Protecting All Against Tetanus Final DraftV4 23jan Web

Protecting All Against Tetanus
Guide to sustaining maternal and neonatal tetanus elimination (MNTE)

and broadening tetanus protection for all populations
FINAL PRE-PRINTING VERSION

23 JANUARY 2019
Protecting All Against Tetanus: Guide to sustaining maternal and neonatal tetanus
elimination (MNTE) and broadening tetanus protection for all populations
ISBN xxxxxxxx
© World Health Organization 2019
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Table of Contents
Acknowledgments .................................................................................................................................. v
Abbreviations and acronyms ................................................................................................................ vi
About this guide ................................................................................................................................... vii
1. Introduction ....................................................................................................................................... 1
Why is there a global goal for maternal and neonatal tetanus elimination (MNTE)? ........................ 2
How can protection against tetanus and MNTE be sustained? .......................................................... 4
2. Building routine immunization (3 primary infant and 3 booster doses of TTCV) for long-term
protection against tetanus ..................................................................................................................... 7
What is the WHO recommended routine vaccination schedule for TTCV?........................................ 8
What TTCVs can be used for the childhood vaccination schedule? ................................................... 9
Why use tetanus-diphtheria containing combination vaccines (DT/Td) rather than TT? ................ 12
Are TTCVs safe? ................................................................................................................................. 13
What strategies can be used to achieve high coverage of the primary series of TTCV? .................. 14
What strategies and opportunities can be used for TTCV booster doses? ...................................... 17
Is it necessary to introduce all three TTCV booster doses into the immunization schedule together
at the same time? ............................................................................................................................. 30
What is the catch-up schedule for children >1 year of age or adolescents who missed or did not
complete the primary series of TTCV? .............................................................................................. 31
What activities need to be undertaken to ensure successful roll out of a routine childhood 6-dose
TTCV schedule? ................................................................................................................................. 33
3. Antenatal care (ANC) contacts and tetanus vaccination status of pregnant women .................... 37
What is the role of vaccinating pregnant women and how will this change as countries establish
the 6-dose routine child/adolescent schedule? ............................................................................... 38
What are current WHO recommendations for antenatal care (ANC) contacts? .............................. 39
How to screen and vaccinate pregnant women for protection against tetanus? ............................ 41
What records/cards do pregnant women need to keep? ................................................................ 44
What does “protection at birth” (PAB) mean and why is it important? ........................................... 45
What is routine administrative TTCV2+ coverage monitoring?........................................................ 47
4. Ensuring clean birth and umbilical cord care practices................................................................... 49
Why are clean birth and umbilical cord care important for MNTE? ................................................. 50
How can clean birth and clean cord care practices be achieved? .................................................... 51
What practices ensure a clean birth and cord care? ........................................................................ 53
What are clean birth kits (CBK) and childbirth checklists? ............................................................... 55
5. Tetanus surveillance ......................................................................................................................... 60
What is tetanus surveillance and why is it necessary? ..................................................................... 61
What are the WHO recommended standards for tetanus surveillance? ......................................... 63
iii
6. Monitoring & Evaluation (M&E) ...................................................................................................... 66
What monitoring and evaluation is required for tetanus vaccination? ........................................... 67
Programmatic M&E: what monitoring tools need to be in place or revised? .................................. 68
How to periodically assess if MNTE status is sustained? .................................................................. 69
Annex 1. What is tetanus? ................................................................................................................ 80

Annex 2. Estimating target populations using UN Population Division estimates and projections . 83
Annex 3. Determining the number of TTCV doses to be administered to a pregnant woman at ANC
contact or health facility – health worker training scenarios ........................................................... 85
Annex 4. How to implement the protection at birth (PAB) method in practice? ........................... 86
Annex 5. Example of national tally sheet for TTCV2+ (or Td2+) for pregnant women .................... 89
Annex 6. Five moments for hand hygiene ....................................................................................... 90
Annex 7. WHO Recommended Surveillance Standards for Neonatal Tetanus (NT) ........................ 92
Annex 8. WHO Recommended Surveillance Standards for Non-NT .............................................. 102
Annex 9. Illustrative example of job aid on screening for vaccine eligibility ................................. 110
Annex 10. Serosurveys.................................................................................................................... 112
Annex 11. Methodology for a post-validation assessment of MNTE ............................................. 123
iv
Acknowledgments
This document was developed by the Expanded Programme on Immunization (EPI),

Department of Immunization, Vaccines and Biologicals (IVB) of the World Health
Organization (WHO) with extensive review and inputs from numerous colleagues in
headquarters and regional offices, individuals and consultants, and partner organizations.
Sincere thanks to all those who contributed their experience and knowledge.
This Guide’s development and publication was possible thanks to support and contributions
from various donors.
v
Abbreviations and acronyms
AEFI Adverse event(s) following immunization

ANC Antenatal care
CBK Clean birth kit
CHD Child Health Days
cMYP Comprehensive multi-year plan
DHS Demographic and Health Survey
HBR Home-based records
HMIS Health management information system
HPV Human papillomavirus
ICC Interagency Coordinating Committee
IEC Information, Education and Communication
LQA-CS Lot quality assurance – cluster sample
MCHD Maternal and Child Health Days
M&E Monitoring and evaluation
MICS Multiple Indicator Cluster Survey
MNTE Maternal and neonatal tetanus elimination
NITAG National Immunization Technical Advisory Group
Non-NT Non-neonatal tetanus
NT Neonatal tetanus
PAB Protection at birth
PCV Pneumococcal conjugate vaccine
PIRI Periodic intensification of routine immunization
RCA Root cause analysis
RED/REC Reaching Every District/Reach Every Child
SBA Skilled birth attendant
SIA Supplementary immunization activity
Td Tetanus-diphtheria toxoid
Tdap Tetanus-diphtheria-acellular pertussis
TIG Tetanus immune globulin
TTCV Tetanus toxoid-containing vaccine
TTCV2+ Two or more TTCV doses at the time of last pregnancy
WRA Women of reproductive age
2YL Second year of life
vi
About this guide
For the first time, this document pulls together in one place all the latest information,
recommendations, and strategies that are required to both sustain maternal and neonatal
tetanus elimination (MNTE) and broaden protection against tetanus for all people. It is a
technical resource that is relevant not only for countries that have already successfully
achieved elimination status, but also for those still working towards MNTE.
This guide is intended for use by national immunization programme managers and staff, and
immunization partners involved in providing implementation support to countries.
The specific objectives of this guide are:

• to describe the strategies and activities required to (i) sustain the elimination of
maternal and neonatal tetanus, and (ii) ensure long-term protection against tetanus
for all people;
• to inform the policy discussions and operational decisions related to tetanus
vaccination and sustaining MNTE at the country level;
• to provide up-to-date references on global policy recommendations as well as
technical and strategic issues.
This document provides guidance and options to assist countries to decide and plan the
policy changes and activities that are needed to successfully sustain MNTE and ensure long-
term protection against tetanus for all populations.
Chapter by chapter, this guide explains how the core programmatic components for
preventing MNT [antenatal care (ANC) vaccination of pregnant women and clean births with
skilled health personnel] are interconnected with the implementation of routine tetanus
vaccination (for both sexes with booster doses across the life course) to ensure elimination
is sustained and that all populations are protected.
vii
1. Introduction
In this introductory chapter you will learn:

• Why there is a global goal for MNTE
• How protection against tetanus and MNTE can be sustained
• What are the recommended strategies for achieving and sustaining MNTE.
You can use this information to:

• Improve/refresh your technical knowledge and understanding of MNTE
• Prepare briefing notes for policy and decision makers (including NITAGs)
• Develop training curriculum for health workers.
1
Why is there a global goal for maternal and neonatal tetanus elimination
(MNTE)?
The burden of maternal and neonatal tetanus

Tetanus: quick facts
(MNT) is a health equity issue affecting those
• The causative agent of tetanus is the
who are the most disadvantaged, poor, and
bacterium Clostridium tetani.
without access to adequate health services.
MNT has often been referred to as a “silent • Spores of C. tetani are found
killer” since the victims often die without everywhere in the environment.
being officially recorded. A case of maternal • Tetanus occurs when spores enter
and/or neonatal tetanus represents a triple the human body through wounds
failure of the public health system – failure of and produce neurotoxin.
the routine immunization programme, failure • Vaccination against tetanus is the
of antenatal care, and failure of ensuring clean main means of protection.
and safe birth practices.
Unlike polio and smallpox, tetanus cannot be eradicated as the spores are ubiquitous in the
environment and there are animal reservoirs (tetanus spores in soil or fomites
contaminated with animal and human faeces can contaminate wounds of all types).
However, MNT can be eliminated through universal active immunization of children,
mothers, and other women of reproductive age and improving maternity care with
emphasis on hygienic birth and cord care practices, i.e. the number of cases can be reduced
to an extent that it ceases to be a public health problem.
Maternal and Neonatal Elimination (MNTE) Goal: key details
When in the late 1980s WHO estimated that annual global neonatal tetanus (NT)
mortality rate was approximately 6.7 NT deaths per 1000 live births, the global health
community committed itself to decrease incidence of NT cases.
• In 1989: the 42nd World Health Assembly called for the elimination of neonatal
tetanus in 59 priority countries by 1995.
• In 1990: the World Summit for Children listed neonatal tetanus elimination as one
of its goals.
• In 1991: the MNTE goal was endorsed by the 44th World Health Assembly, but due
to slow implementation of the recommended strategies for NT elimination, the
target date for the attainment of elimination by all countries was postponed to
2000.
• In 1999: progress towards the attainment of the global elimination goal was
reviewed by UNICEF, WHO, and UNFPA, and the Initiative was re-constituted.
Elimination of maternal tetanus was added to the goal with a 2005 target date,
which was later shifted to 2015.
• By the end of 2015, there were still 21 countries that had not yet attained
elimination.
• Progress continues: today only 14 countries remain to eliminate MNTE.
2
While considerable progress has been achieved, by end 2018, 14 countries in three regions1
still have not reached MNTE status. Figure 1 shows the dynamic of progress made by the
countries since neonatal tetanus (NT) was first declared a target in 1989.
Figure 1
Maternal and neonatal tetanus elimination progress since 1989: priority countries validated for
elimination
1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999
NT World Goal again Initial New
eliminatio Summit for endorsed at eliminatio elimination
n declared Children the 44th n target initiative
a goal at included NT Health launched
42nd elimination Assembly including
Health as a goal maternal
Assembly tetanus
targeting 59
countries
Countries
achieving
MNTE
validation Burundi Benin
Nepal Egypt Comoros Mozambiqu
Malawi Togo Zambi Banglades Congo e
Zimbabwe Namibia S. Africa Eritrea Rwanda Vietnam a h Turkey Myanmar
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
2nd
eliminatio
n target
Countries
achieving
MNTE
validation
Burkina Fas
o Cote d’Ivoir
Cameroon e
Ghana China Gabon Cambodia
Liberia G. Bissau Iraq India Eq. Guinea Ethiopia
Senegal Tanzania Laos PDR Madagasca Mauritani Indonesia Haiti
Uganda Timor Leste Sierra Leone r a Niger Philippines Kenya
2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
3rd 4th
eliminatio eliminatio
n target n target
1
The priority countries where MNT is still a public health problem include: Afghanistan, Angola, Central African
Republic, Chad, Congo DR, Guinea, Mali, Nigeria, Pakistan, Papua New Guinea, Somalia, Sudan, South Sudan
and Yemen. Two countries have partially eliminated MNT: Pakistan (Punjab province) and Nigeria (south-east
region).
3
Global Vaccine Action Plan (GVAP) goal 2: Achieve MNTE by 2020
• As a result of implementing recommended strategies in the period 1988–2015, the

global estimate of NT deaths declined by 96%.
• Almost all the remaining priority countries will achieve MNTE by the GVAP) target of
2020, if implementation challenges are addressed such as vaccinating high-risk
populations due to geographical and/or security issues.
• Efforts must be made to ensure funding for activities and innovative approaches (e.g. TT
Uniject) to reach vulnerable populations.
For latest update on the progress towards MNTE see GVAP Secretariat Report (2018) available online at:
http://www.who.int/immunization/global_vaccine_action_plan/previous_secretariat_reports_immunization_scorecards/
en/.
The elimination of neonatal tetanus as a public health problem is defined as having less
than one NT case per 1 000 live births in every district or similar administrative unit in the
country each year. Maternal tetanus is assumed to be eliminated once NT elimination has
been achieved2.
As more and more countries are validated3 as having achieved MNTE, attention and
activities must shift towards ensuring that this accomplishment is sustained over the long
term.
More information on MNTE initiative, strategies and validation of MNT elimination, and
programmatic update is available at
http://www.who.int/immunization/diseases/MNTE_initiative/en/. For more on tetanus
disease see Annex 1.
How can protection against tetanus and MNTE be sustained?
The principal strategies for achieving MNTE focused on provision of tetanus toxoid (TT)
immunization through routine and supplementary immunization activities (SIAs) to
vaccinate women 15-49 years of age in areas with limited access to health services,
strengthening of clean birth services, and effective surveillance to detect areas and
populations at high risk for NT. Although these strategies have been very successful, once
2
The neonatal tetanus indicator acts as a proxy for maternal tetanus.
3
For overview of MNTE validation process see
http://www.who.int/immunization/diseases/MNTE_initiative/en/index2.html.
4
elimination status is achieved, the strategies used to reach it need to be adjusted to sustain
elimination (see Table 1).
Table 1
Recommended strategies for achieving and sustaining MNTE
ACHIEVING MNTE SUSTAINING MNTE
Strengthen antenatal care (ANC) Strengthen immunization of pregnant

immunization of pregnant women with women and routine vaccination of all
tetanus toxoid-containing vaccine (TTCV). children/adolescents (both sexes) to receive
3 primary infant doses and 3 booster doses
of TTCV before adolescence.
TTCV Supplementary Immunization Antenatal screening of pregnant women to

Activities (SIAs) in selected high risk areas, verify tetanus vaccination status (to ensure
targeting women of reproductive age (15– tetanus protection at birth – PAB) and
49 years) with 3 properly-spaced doses of vaccinate if required.
the vaccine.
Increased access to skilled health
Promotion of clean birth and clean cord personnel at birth and clean birth/cord care
care practices and health education. practices.
Strong T/NT surveillance and regular

Reliable NT surveillance including case review of data to identify districts at risk of
investigation and response. re-emergence of MNT and needing
corrective action.
Sustaining MNTE requires a comprehensive multi-pronged approach. In the short to

medium term, key activities will continue to focus on women but plans need to begin to
shift towards adjusting the national immunization schedule to provide long-term protection
against tetanus for all people. This means achieving high coverage for both sexes with 6
doses of tetanus toxoid-containing vaccine (TTCV4) – 3 primary infant doses and 3 booster
doses through routine childhood and adolescent vaccination5. Once high homogeneous
vaccination coverage (≥90%) with the 6-dose child/adolescent schedule has been realized, a
large share of future cohorts of women of reproductive age (WRA) will be fully protected
against tetanus throughout their reproductive years and beyond. As a result, antenatal care
(ANC) contacts will increasingly be used to screen and verify the vaccination status of
4
Since 1998 WHO has recommended that all countries replace tetanus toxoid (TT) with the combination
tetanus-diphtheria (Td) vaccine, in order to sustain protection against diphtheria following waning immunity
after the primary series.
5
WHO (2017). Tetanus vaccines. WHO Position Paper. Weekly Epidemiological Record. 92:53–76
(http://www.who.int/immunization/policy/position_papers/tetanus/en/, accessed 22 November 2018).
5
pregnant women, and less as the primary means to vaccinate them with TTCV. This will also
make SIAs targeting WRA unnecessary.
Figure 2
Overview of activities and strategies to sustain MNTE
6
Plans for achieving/sustaining MNTE should be included in the country’s comprehensive
multiyear plan (cMYP) for immunization. The guidelines for developing/revising a cMYP
are available online at:
http://www.who.int/immunization/programmes_systems/financing/tools/cmyp/en/.
2. Building routine immunization (3 primary infant and 3 booster

doses of TTCV) for long-term protection against tetanus
In this chapter you will learn:

• The WHO recommended routine vaccination schedule for TTCV;
• What vaccines to use, and when and why to use DT/Td rather than TT;
• Strategies to achieve high coverage for the primary series of TTCV;
• Strategies and opportunities for TTCV booster doses;
• Interim strategy for TTCV booster dose introduction using multi-age cohort
vaccination schedules;
• Catch-up schedule for children >1 year old or adolescents with incomplete or
unknown TTCV primary series vaccination status;
• Activities to ensure successful roll-out of a routine childhood 6 dose TTCV
schedule.

• Plan the introduction of TTCV booster doses to help achieve and/or sustain MNTE,
and so that all persons are protected;
• Decide the best delivery strategies for 3 booster contacts in your country;
• Develop an introduction plan with necessary activities.
7
What is the WHO recommended routine vaccination schedule for TTCV?
In 2017 WHO issued updated policy recommendations for tetanus vaccination6. WHO
recommends that all populations worldwide should be vaccinated against tetanus. In order
to provide protection throughout adolescence and adulthood, national immunization
programmes should provide a total of 6 doses consisting of 3 primary infant doses and 3
booster doses, preferably administered in childhood and completed by adolescence (Box 1).
Box 1
WHO recommendation: routine vaccination schedule for TTCV
Primary series: The primary infant series of 3 doses of TTCV is the foundation for building
lifelong immunity, with the first dose administered from 6 weeks of age. Subsequent
doses should be given with a minimum interval of 4 weeks between doses. If possible, the
primary series should be completed by 6 months of age.
Booster doses: Three booster doses should be given at ages: 12–23 months, 4–7 years,
and 9–15 years. Ideally, there should be at least 4 years between boosters.
Note: All HIV-infected children should be vaccinated against tetanus following the same schedule.
Data from serological studies suggest that a primary series of 3 TTCV doses in infancy plus a
booster during the second year of life (12–23 months) will provide 3–5 years of protection.
A further booster dose (e.g. in early childhood, or at school entry, 4–7 years) will provide
protection into adolescence, and another booster during adolescence (9–15 years) will
induce immunity that lasts through much of adulthood and which protects women through
their childbearing years (Figure 3).
6
Other background documents can be found at:
http://www.who.int/immunization/sage/meetings/2016/october/presentations_background_docs/en/ and
http://www.who.int/immunization/policy/position_papers/tetanus/en/.
8
Within age limits specified above, countries can adjust or tailor their TTCV vaccination
schedule based on local epidemiology, the objectives of the immunization programme, or
any programmatic issues or opportunities (e.g. existing child health contacts), keeping in
mind the optimal 4-year interval between boosters.
What TTCVs can be used for the childhood vaccination schedule?
Tetanus toxoid is available in a single-antigen vaccine (TT) and in combination vaccines

against other vaccine-preventable diseases such as diphtheria, pertussis, polio, hepatitis B,
and Haemophilus influenzae type b.
Many different TTCVs are licensed worldwide. The choice of which TTCV to use and when
depends on many factors such as price, supply availability, target age, programmatic
simplicity, cold chain capacity, and other vaccines in the national immunization schedule.
National immunization programmes have considerable flexibility in the choice of TTCVs and
given the above mentioned factors, it is expected that the same TTCV product may not be
used for all six of the childhood doses. Table 2 provides a summary of the TTCV product
options that currently exist.
TTCVs can be co-administered with other childhood vaccines. All vaccines that are age-
appropriate and consistent with the child’s prior immunization history can be administered
during the same visit. However, conjugate vaccines such as Hib (PRP–TT) and MenA (PsA–
TT), unless co-administered with TTCV (i.e. given at the same visit), should be administered
at least one month before TTCV.
WHO recommendations for childhood vaccination for tetanus and diphtheria are the
same.
It is important to note that WHO recommendation for diphtheria childhood vaccination
follows the same schedule as tetanus (i.e. 3 primary infant doses of diphtheria toxoid-
containing vaccine, plus 3 booster doses as 12–23 months, 4–7 years, and 9–15 years).
WHO recommendations for childhood vaccination for tetanus and pertussis are aligned.
After the primary infant series (3 doses), a booster dose of pertussis vaccine is
recommended for children aged 1–6 years, preferably during the second year of life (≥6
months after last primary dose), unless otherwise indicated by local epidemiology. This
schedule should provide protection for at least 6 years for countries using whole-cell
9
pertussis vaccines (wP). For countries using acellular pertussis (aP) vaccine, protection
may decline appreciably before 6 years of age.
See WHO vaccine position papers at http://www.who.int/immunization/documents/positionpapers/en/.
10
Figure 3
WHO recommended vaccination schedule and duration of protection
11
Table 2
Tetanus vaccination schedule and TTCV product options
(WHO-prequalified vaccine options in regular font, non-prequalified vaccines in italics)
Primary series 2nd year of life (12–23 months) 4–7 years 9–15 years
(3 doses) (1st booster)* (2nd booster) (3rd booster)
• DTwP or DTaP** • DTwP or DTaP • DTwP or DTaP • Td
• Quadrivalent • Quadrivalent (DTwP-HepB, • DT or Td • TdaP***
(DTwP-HepB; DTwP-Hib; DTaP-HepB,
DTaP-HepB; DTaP-Hib)
DTaP-Hib; DTwP- • Pentavalent (DTwP-Hib-
Hib) HepB; DTPaP-Hib-IPV;
• Pentavalent DTaP-HepB-IPV)
(DTwP-Hib-HepB; • Hexavalent (DTaP-Hib-
DTaP-Hib-IPV; HepB-IPV)
DTaP-HepB-IPV)
• Hexavalent
(DTaP-Hib-HepB-
IPV)
* WHO recommends that a pertussis containing combination vaccine is preferred for the TTCV booster
administered in the second year of life (2YL).
**In most countries the use of DTP for the primary series has been replaced by quadrivalent or pentavalent
vaccines.
***Only acellular pertussis (aP) should be used for persons >7 years of age.
For up-to-date product information on the different TTCVs that are prequalified7 by WHO
check: http://www.who.int/immunization_standards/vaccine_quality/PQ_vaccine_list_en/en/.
For up-to-date information on UNICEF Supply Division vaccine prices see:
https://www.unicef.org/supply/index_57476.html.
Why use tetanus-diphtheria containing combination vaccines (DT/Td)

rather than TT?
To avoid the threat of diphtheria outbreaks and to improve protection against diphtheria,
since 1998 WHO has recommended that all countries replace TT with Td for vaccination of
reproductive age/pregnant women, older children and adolescents. The WHO position
paper on diphtheria vaccine8 provides the background for this recommendation.
7
WHO provides a service to UNICEF and other UN agencies that purchase vaccines, to determine the
acceptability, in principle, of vaccines from different sources for supply to these agencies. For an overview of
the procedure see http://www.who.int/immunization_standards/vaccine_quality/pq_system/en/.
8
WHO (2017). Diphtheria vaccine. WHO Position Paper. Weekly Epidemiological Record. 92: 417–436
(http://apps.who.int/iris/bitstream/handle/10665/258681/WER9231.pdf?sequence=1, accessed 22 November
2018).
12
Although simply replacing TT with Td vaccine provides dual protection with negligible
programmatic shift and marginal increase in cost, globally, however, this replacement has
been incomplete and somewhat slow. As of May 2018, 133 of 194 countries made the
change from TT to Td, which has been proven to be safe and cost effective. Yet, there are
still about 61 countries remaining to fully implement the recommendation in order to
ensure longer lasting protection against diphtheria. In the light of the important public
health benefits of replacing TT with Td, as of January 2020 UNICEF will no longer procure
and/or supply TT vaccine.
Box 2
WHO/UNICEF Guidance on TT-Td replacement
WHO/UNICEF Guidance Note on replacing TT with Td

vaccine (12 September 2018) – provides background,
rationale and practical action steps to make change
from TT to Td.
Available online at:
https://www.unicef.org/health/files/Guide_to_TT_to_T
d_Replacement_Final_12.09.2018.pdf.
Are TTCVs safe?
TTCVs have an excellent safety record. Mild local reactions (e.g. redness, swelling, pain) and
systemic reactions (e.g. fever ≥38°C, irritability, malaise) are common after both primary and
booster TTCV administration. In general, combination vaccines do not result in increased
frequency and/or severity of adverse reactions compared to the individual vaccines given
alone. Serious reactions, for example anaphylaxis or brachial plexus neuritis are very rare or
extremely rare respectively.
For further information on TTCV vaccine safety refer to WHO position paper on tetanus
vaccine9 and a WHO information sheet Observed rate of adverse reactions for diphtheria,
pertussis, and tetanus vaccines available online at:
http://www.who.int/vaccine_safety/initiative/tools/DTP_vaccine_rates_information_sheet.pdf?ua=
1.
9
13
What strategies can be used to achieve high coverage of the primary series
of TTCV?
The first three primary doses of TTCV in the infant vaccination schedule are most commonly
given at 6, 10 and 14 weeks, or 2, 3, 4 months, or 2, 4 and 6 months. These doses are the
foundation for building long-term immunity to tetanus, and therefore it is essential that
national immunization programmes strive to achieve the GVAP coverage goal of ≥90% (with
at least 80% coverage in every administrative unit).
High vaccination coverage depends on well-functioning immunization programmes, strong

health systems and acceptance/demand from the population. There exist many strategies
and resources to assist countries to improve their infant vaccination coverage (see Box 3).
Key among these is the Reaching Every District (RED) approach.
Reaching Every District (RED) approach*
The RED approach highlights the following five operational components to increase vaccination
coverage:
1. Planning and management of resources – for better managing of human, material and
financial resources.
2. Reaching all eligible populations – for improving access and use of immunization and other
health services by all children, adolescents and adults.
3. Monitoring and using data for action – for analyzing the data at all levels to direct the
programme in measuring progress, identifying areas needing specific interventions and making
practical revisions to plans.
4. Supportive supervision – for regular on-site capacity-building, feedback, and follow-up with
health staff.
5. Engaging with communities – for partnering with communities to promote and deliver
immunization services which best fit local needs.
*WHO Regional Office for Africa (2017). Reaching Every District (RED). Brazzaville: WHO Regional Office for Africa
14
Box 3
WHO resources for increasing vaccination coverage
Global Routine Immunization Strategies and

Practices (GRISP) – contains a comprehensive
framework of strategies and practices for routine
immunization, and nine transformative investments
to achieve better immunization programme
outcomes. Available online at:
http://apps.who.int/iris/bitstream/handle/10665/2
04500/9789241510103_eng.pdf?sequence=1.
Reaching Every District (RED), 2017 Edition – a

guide to increasing coverage and equity in all
communities in the African Region. Its purpose is to
support countries to plan and implement the five
components of the RED approach.
http://www.afro.who.int/sites/default/files/2018-
02/Feb%202018_Reaching%20Every%20District%20
%28RED%29%20English%20F%20web%20v3.pdf.
Reducing Missed Opportunities for Vaccination

(MOV) - resource guides for reducing MOV by
making better use of existing vaccination sites and
existing health contacts.
http://www.who.int/immunization/programmes_sy
stems/policies_strategies/MOV/en/.
Periodic Intensification of Routine Immunization

(PIRI) – a paper which summarizes a wide array of
PIRI experiences, based on a desk review of
available documents and grey literature.
http://www.who.int/immunization/programmes_sy
stems/policies_strategies/piri_020909.pdf?ua=1&u
a=1.
15
Immunization in Practice (2015 revision) – a
practical guide targeted at district and health
facility staff, building upon the experiences of polio
eradication.
93412/9789241549097_eng.pdf?sequence=1.
Guide to Tailoring Immunization Programmes

(2013) – provides tools to identify susceptible
populations, determine barriers to vaccination and
implement evidence-based interventions in order
to assist national immunization programmes design
targeted strategies that increase uptake of infant
and childhood vaccinations.
Available online with other related publications at:
http://www.euro.who.int/en/health-
topics/communicable-
diseases/poliomyelitis/activities/tailoring-
immunization-programmes-to-reach-underserved-
groups-the-tip-approach/the-tip-guide-and-related-
publications.
Training for Mid-Level Managers (MLM) – 8

modules on the operational components of the
routine immunization programme.
http://www.who.int/immunization/documents/ml
m/en/.
16
What strategies and opportunities can be used for TTCV booster doses?
In addition to completing the primary series, WHO recommends that three booster doses of
TTCV should be administered as follows:
(i) 1st booster: in the 2nd tear of life (12–23 months of age)
(ii) 2nd booster: between 4–7 years of age
(iii) 3rd booster: between 9–15 years of age.
In many low-income countries, national immunization programmes do not have any booster
doses of vaccines in their current schedules. Therefore, experience providing vaccination to
older target age groups may be limited. While there is increasing attention of the need to
vaccinate throughout the life-course, extending vaccination beyond the first year of life can
be a challenging step which takes special effort and planning to be successful.
In many ways, introducing a booster dose can be similar to the introduction of a new
vaccine – it requires all of the same processes such as decision-making, policy revision,
supply forecasting, cold chain capacity assessment, training of health staff, revision of
home-based records (child vaccination cards), adaptation of recording and reporting
forms/systems, advocacy, communication and social mobilization, strengthened
supervision, etc. (see What activities need to be undertaken to ensure successful roll out of
a routine childhood 6-dose TTCV schedule?, page 32).
Deciding on the best age and strategy to deliver a TTCV booster dose involves careful review
of the opportunities and challenges. Each country will have its unique context and synergies
with other programmes/interventions to consider. The possible platforms to build upon for
each of the TTCV boosters are highlighted below.
(i) 1st TTCV Booster in the second year of life (2YL platform)
Providing a TTCV booster between 12–23 months aligns with other WHO childhood
vaccination recommendations such as the 2nd dose of measles-containing vaccine (MCV2),
meningitis A, and alternative 2+1 schedules for PCV10, as well as boosters of pertussis and
diphtheria11. Additionally, countries may have a well-child visit, vitamin A supplementation,
and/or deworming contacts scheduled within this age range.
Importantly, a 2YL vaccination contact also provides the opportunity to catch up children on
doses of any vaccines they may have missed earlier. In this way, the coverage levels of fully
10
Alternative PCV 2+1 schedule: 2 doses of PCV before 6 months of age, plus booster dose at 9-15 months of
age.
11
See WHO Recommendations for Routine Immunization: Summary Tables, available online at:
http://www.who.int/immunization/policy/immunization_tables/en/.
17
immunized children by 2 years of age (FIC2) can be increased and the individual/public
health benefit of greater population immunity realized.
Comprehensive guidance documents already exist for introducing a routine second dose of
measles vaccine, and for 2YL vaccination (see Box 4). These materials contain detailed
information which is relevant and helpful for planning and implementing a 1st TTCV booster
in the 2YL.
Regarding the options of the vaccine product that can be used for the 1st TTCV booster
please refer to Table 2.
WHO recommends that both pertussis and diphtheria boosters should be given to
children in the second year of life, so the use of TTCV combination vaccines that include
these antigens is strongly encouraged.
For children 12–23 months, combined vaccines with diphtheria antigen should contain full
strength paediatric formulation (i.e. capital “D”, not small “d”).
Box 4
WHO resources for planning the introduction of interventions in the routine immunization
programme in the second year of life (2YL)
A Guide to Introducing a Second Dose of Measles into

Routine Immunization Schedules (2013) – provides
guidance to support policy discussions and operational
aspects of the introduction of a second dose of measles
vaccine into the routine immunization schedule.
/WHO_IVB_13.03_eng.pdf.
Establishing and strengthening immunization in the

second year of life: Practices for vaccination beyond
infancy (2018) – provides practical guidance on how to
improve vaccination coverage during a scheduled visit in
the second year of life that may include other child
health interventions.
6/9789241513678-eng.pdf.
18
A handbook for planning, implementing, and
strengthening vaccination into the second year of life
(2019)
A companion resource to the WHO publication

‘Establishing and strengthening immunization in the
second year of life: Practices for vaccination beyond
infancy’.
(https://www.who.int/immunization/programmes_syste
ms/policies_strategies/2YL/en/)
(ii) 2nd TTCV Booster at 4–7 years

For many national immunization programmes, providing vaccination between 4–7 years of
age can be an entirely new endeavour. The same introduction processes described above
for the 1st TTCV booster dose will need to be considered.
Depending on a country’s programme and capacity, reaching children 4–7 years of age may
be challenging. If vaccination is to be delivered through fixed-site services (either clinic-
based or outreach) then an investment in information, education, and communication (IEC)
will be necessary to ensure mothers/caregivers understand the need to bring their older
children back for vaccination. This IEC effort will need to be continued for many years in
order to change behaviours and assure demand and ultimately high coverage.
A day-care/crèche- or school-based vaccination strategy is an option, as 4–7 years is the age

when many children are in day-care or begin primary school. This may also be an
opportunity to implement school entry vaccination screening at the time of enrolment, to
determine if children of this age have been fully vaccinated. Children with incomplete
vaccination must be referred to health services to determine eligibility and receive their
missing vaccine doses. Such an approach will require strong collaboration with the Ministry
of Education, policy directives, and possibly a legislative or legal framework to empower the
implementation. Depending on the national context, issues of parental consent may also
need to be addressed if vaccination is to take place in nurseries/day-care/crèches/primary
school because children will be unaccompanied by their mothers/caregivers, unlike for
infant vaccination. See Box 6 for WHO document on consent to vaccination.
There are multiple factors to consider when deciding to implement vaccination in schools or
nurseries/day-care/crèches. These are further discussed in the section on the 3rd TTCV
booster dose below.
19
(iii) 3rd TTCV Booster at 9–15 years
Reaching children/adolescents in the 9–15 year old age group with a booster dose of TTCV is
particularly important because it is this age group which is approaching their reproductive
years. Girls especially need to have their tetanus immunity strengthened by a 3rd booster
dose to enable the transfer of antibodies to their newborn (protection at birth) during
future pregnancies. For coverage equity, boys also need to be protected against tetanus to
avoid any future risk of exposure through contamination of wounds from medical
interventions, occupational risks or accidents.
Moreover, when both boys and girls are vaccinated, it can help avoid false rumours about
female sterilization and contraception which have sometimes accompanied tetanus
vaccination activities that targeted girls and women only.
For the 3rd TTCV booster between 9–15 years, there are two current platforms that can
provide opportunities for integration. Within the immunization programme there is the
provision of HPV vaccine (which targets roughly the same age group). More broadly, there is
the global momentum for improving adolescent health (see Box 5).
WHO recommendations for HPV vaccination* and tetanus 3rd booster dose overlap
For girls 9–14 years, WHO recommends a 2-dose schedule of HPV vaccine with a 6-month interval
between doses. An interval no greater than 12–15 months is suggested in order to complete the
schedule promptly and before becoming sexually active. If the interval between doses is shorter
than 5 months, a third dose should be given at least 6 months after the first dose.
A 3-dose schedule (0, 1–2, 6 months) should be used for all HPV vaccinations initiated ≥15 years of
age. Three doses are also needed for those younger than 15 years who are known to be
immunocompromised and/or HIV-infected.
Opportunities should be sought to link the introduction of HPV vaccination to other

vaccinations carried out at the same age (e.g. diphtheria and tetanus vaccination) and
programmes targeting young people (e.g. through school and adolescent health services).
* WHO (2017). Human papillomavirus vaccines. WHO Position Paper. Weekly Epidemiological Record.
92:241–268.
The vast experience from pilot and/or nationwide HPV vaccine introductions can help to
inform the decision, design, and planning for an adolescent TTCV booster (see Box 6).
Where HPV vaccination activities are already part of the national immunization programme,
the 3rd dose of TTCV can be integrated and delivered together with HPV, although for TTCV
it is necessary to vaccinate both boys and girls. As of October 2018, more than 85 countries
have introduced HPV vaccine, and in some Td and other vaccines are co-administered
during the same visit. But many countries that have introduced HPV vaccine have not yet
taken advantage of the opportunity to link HPV and Td vaccination.
20
Box 5
Global commitment to adolescent health
There are few interventions targeting young adolescents, and those that do exist are not
adequately reaching them. This is because the number of contacts with adolescents in the health
system is generally low.
For years, the unique health issues associated with adolescence have been little understood or in
some cases, ignored. But this has now changed.
Adolescent health and development was made an integral part of the

Global Strategy for Women’s, Children’s and Adolescents’ Health (2016-
2030) (The Global Strategy) in support of the Sustainable Development
Goals (SDGs). Available online at: http://www.who.int/life-
course/partners/global-strategy/globalstrategyreport2016-2030-
lowres.pdf.
The Global Accelerated Action for the Health of Adolescents (AA-HA!):

Guidance to Support Country Implementation (2017) provides technical
guidance to policy-makers and programme managers as they respond to
the health needs of adolescents in their countries. Available online at:
http://apps.who.int/iris/bitstream/handle/10665/255415/9789241512343-
eng.pdf?sequence=1.
A multimedia interactive report, Health for the World’s Adolescents: A

Second Chance in the Second Decade (2014) provides global and regional
overview of health–related behaviours and conditions among adolescents,
pulls together WHO recommendations and guidance, and proposes key
actions and approaches that would strengthen national responses to
adolescent health issues. This report is available online at:
http://www.searo.who.int/indonesia/documents/health-for-world-
adolescent-who-fwc-mca-14.05-eng.pdf?ua=1.
21
Box 6
HPV vaccine introduction resources to inform planning and implementation of TTCV adolescent
booster
A guide to introducing HPV vaccine into national

immunization programmes (2016) – provides policy and
operational aspects of HPV vaccine introduction and up-
to-date references on global policy and technical and
strategic issues.
3/9789241549769-eng.pdf?sequence=1.
Resources on delivery strategies:
Scaling up HPV vaccine introduction (2016) – provides a

summary of country-reported experiences introducing
HPV vaccine in their national immunization programme.
9/9789241511544-eng.pdf?sequence=1.
HPV Vaccine Lessons Learnt – comprehensive review of

HPV vaccine delivery experiences across 46 low- and
middle- income countries.
Available online at PATH Cervical Cancer Library:
http://www.rho.org/HPVlessons/index.htm.
HPV Vaccine Communication: Special considerations

for a unique vaccine (2016 update) – provides
communication guidance for countries introducing HPV
vaccine at the national or subnational levels.
9/WHO-IVB-16.02-eng.pdf?sequence=1.
22
Considerations regarding consent in vaccinating
children and adolescents between 6 and 17 years old
(2014) – provides principles and practical approaches to
obtaining consent for vaccinations among
unaccompanied minors.
8/WHO-IVB-14.04-eng.pdf?sequence=1.
Options for linking health interventions for adolescents

with HPV vaccination (2014) – provides an evidence-
based overview of opportunities for synergy and joint
delivery of HPV vaccination with other interventions.
http://www.who.int/immunization/diseases/hpv/AdoPl
usHPV.pdf?ua=1.
There are several commonly used strategies for HPV vaccination which would be adaptable
for TTCV booster delivery:
— vaccine delivery at health-care facilities (may be in conjunction with schools)
— vaccine delivery through outreach (including school-based outreach)
— vaccine delivery through campaigns.
Vaccination at health facilities

Adolescent vaccination at health facilities has been shown to achieve more coverage if
offered as “vaccination days” with minor incentives for those who attend (such as short
waiting times, music, discussion groups, or videos in the waiting areas).
However, a fixed-site, health-care facility delivery strategy may not be effective if there are
barriers for adolescents to access the health-care facility, for example, if opening hours are
not convenient, or if the health facility is far away.
Schools can have an active role in a facility-based delivery strategy. For example, in some
countries, schools are notified on a specific day to bring children/adolescents for vaccination
to the health facility or nearest scheduled outreach session.
23
Vaccination through outreach
In the context of vaccine delivery, outreach refers to any strategy that requires health
workers to leave their facility in order to transport and deliver vaccination services to a
variety of permanent or temporary sites close to large numbers of the target population.
Some examples of outreach venues are community centres, school buildings, markets or
places of worship, if appropriate.
School-based (outreach) strategy

In most countries, ˃90% of both boys and girls attend primary school. In countries where
school health programmes exist and a designated healthcare worker provides regular health
services either at the school or at the health facility, the operational costs of adding TTCV
vaccine delivery to an existing and already funded school health programme infrastructure
may be minimal, assuming the costs for salary and transport are already provided in the
health budget.
If, however, a school health programme with designated staff does not exist, a school-based
delivery strategy may require the health facility staff to travel away from the health centre
to reach all the schools in the catchment area. This is likely to require additional resources
and can be disruptive to delivery of regular services. It may also be inefficient if school
enrolment is low. In this case, special complementary efforts to reach and vaccinate out-of-
school adolescents with TTCV would be needed.
The learning from measles, polio and HPV vaccination is that school-based programmes can
be highly successful. If implemented in a campaign mode they may be costly, however, a
school platform can deliver benefits across interventions and presents an opportunity to
share costs. It should be noted that school children are exposed to a tetanus risk by
participating in various school activities (e.g. sports, gardening). Therefore, TTCV should be
offered to school children of both sexes. Before initiating a school-vaccination programme,
countries need to be able to assess the capacity, strengths, and weaknesses of their school
and health systems to support such programmes (see Box 7).
Box 7
WHO publication for readiness assessment of schools to support vaccination programmes
School Vaccination Readiness Assessment Tool – provides

methodology specifically designed to assess country-wide
readiness to implement school vaccination. It also provides
information useful for assessing and subsequently improving
broader school health services.
http://www.who.int/immunization/hpv/plan/school_readiness_
assessment_tool_who_2013.pdf.
24
Interim strategy: using schools to catch up and deliver three booster doses
A routine 6-dose TTCV childhood schedule is the preferred tetanus vaccination strategy
because it offers continuous protection throughout childhood, elicits a stronger immune
response, and results in early life-long protection for both boys and girls.
While countries work towards building a routine childhood 6-dose TTCV schedule, some
interim strategies may be considered specifically targeting young children/adolescents so
that they are fully protected against tetanus prior to entering their reproductive years. If
high coverage can be achieved, this approach can contribute significantly to sustaining
MNTE, thus reducing thus the need for vaccination through ANC clinics and SIAs. As an
alternative interim strategy, the complete TTCV 3-dose booster series with Td vaccine could
be delivered in primary school using the multi-age cohort schedule proposed below. After 3
years of implementation, the older grades will have been caught up and boosters will need
to be administered only to grades A, B and C.
School multi-age cohort Td vaccination strategy

Years since start
Level Year 4 and
Year 1 Year 2 Year 3
of enrolment beyond
Grade A 1st booster dose 1st booster dose 1st booster dose 1st booster dose
Grade B 1st booster dose 2nd booster dose 2nd booster dose 2nd booster dose
Grade C 1st booster dose 2nd booster dose 3rd booster dose 3rd booster dose
Grade D 1st booster dose 2nd booster dose 3rd booster dose
Grade E 2nd booster dose 3rd booster dose
Grade F 3rd booster dose
High enrolment and attendance, plus good record keeping in order to track doses and
children who change or drop-out of school are essential for success.
Vaccination through campaigns

In some instances there may be benefits or opportunities to deliver a TTCV booster through
a campaign. It may be possible to include a TTCV booster as part of another planned
campaign such as Child Health Days/Weeks, measles-rubella vaccination campaigns
targeting up to 15 year olds, or even invite the adolescent boys to attend tetanus
supplementary immunization campaign planned for reproductive age women (preferably
using Td). Provided that resources are available, countries may wish to organize a catch-up
campaign for the 3rd TTCV dose booster targeting all 9–15 year old children, before reverting
25
to a routine health-facility based vaccination strategy to deliver the booster dose to all
future cohorts of 9 year olds.
In countries with very small and/or hard-to-reach populations (for example, island states)
the use of a campaign strategy for TTCV adolescent booster may be the most practical and
cost-effective. This strategy could be repeated every 5–6 years to ensure complete coverage
of the next cohort of adolescents 9–15 years.
In order to boost routine coverage in all children, WRA, and pregnant women, countries
may opt for a “hybrid” approach, referred to as periodic intensification of routine
immunization (PIRI). PIRI activities are time-limited, and depending on local planning and
flexibility to arrange outreaches, may be organized once or twice a year. During PIRI, routine
services are intensified and expanded to include not only fixed and outreach strategies but
also many additional vaccination posts and possibly house-to-house services.
Table 3 provides a summary of considerations for different TTCV 3rd dose booster delivery
strategies which are also applicable to the 2nd booster for 4–7 year olds. In practice, a
balance of the pros and cons will need to be made. Countries may need to consider trade-
offs between strategies that maximize coverage and those that are most feasible, affordable
and sustainable. Ultimately, a combination of strategies may be required to achieve high
coverage while optimizing resources.
Regardless of the strategy applied, doses should be correctly tallied and recorded in facility-
based administrative records and recorded on the appropriate home-based child or
adolescent record. Long term retention of records should be ensured so that the history of
tetanus vaccination can be verified. WHO has produced a number of resources that provide
practical experience and guidance on the design and use of home-based records (see Box 8).
NOTE: During the transition period, as countries move away from the high-risk SIA approach
of vaccinating women of reproductive age (except in selected hard-to-reach areas with
limited health services) and work towards providing 3 childhood booster doses of TTCV, it
may be necessary to catch up young children/adolescents who were not able to benefit
from the provision of the first two TTCV boosters (i.e. at 12–23 months and 4–7 years). This
is discussed in section Vaccination through outreach (page 25).
26
Box 8
WHO resources on home-based records
Practical Guide for the Design, Use and Promotion of Home-

Based Records in Immunization (2015) — In response to a
recognized need for more guidance on the content and design
of home-based records, WHO has developed a practical guide
to provide direction to immunization programme managers
and national health programmes on how to improve the use
and design of home-based records, and serve as a reference
with developing or revising home-based records.
http://www.who.int/immunization/monitoring_surveillance/r
outine/homebasedrecords/en/.
The home-based vaccination record repository — An online

repository for home-based vaccination records, including
national immunization or child health cards, is maintained by
UNICEF to support the free and open exchange of information
related to home-based record content and design, with the
aim of improving child health outcomes.
Available online at: https://www.technet-
21.org/en/topics/home-base-records.
WHO recommendations on home-based records for

maternal, newborn and child health (2018) — This report
summarizes the final recommendation and the process for
developing the guideline on home-based records for maternal,
newborn and child health. The primary audience for the
guideline is policy makers and health programme managers of
MNCH and immunization programmes in ministries of health
where decisions are made and policies created on the use and
implementation of home-based records.
www.who.int/maternal_child_adolescent/documents/home-
based-records-guidelines/en/.
27
Table 3
Considerations for different adolescent (3rd booster dose) TTCV delivery strategies
DELIVERY STRATEGY
CONSIDERATIONS OUTREACH
HEALTH FACILITY COMMUNITY OUTREACH SCHOOL-BASED OUTREACH CAMPAIGN
Access Adolescents must come to health A variety of locations is possible If enrolment is high, larger number of Large number of adolescents can be
centre (may not be successful if adolescents vaccinated at the same time vaccinated at the same time
the adolescents are shy; requires May need special communications effort
facilities to be “adolescent to make sure adolescents attend (e.g. Requires health workers to travel to Large number of vaccinators needed
friendly”) through social media) school (may disrupt regular services)
May need coordination with Requires health workers to leave health Parental consent process Can be used as initial “catch-up” of
schools to encourage and release facility but can be part of regular health several age cohorts
adolescents to go to facility facility outreach Teachers can assist with vaccination
sessions
Parents may be present at time of
vaccination
Does not require health workers

to leave
Working hours may need to be

adapted to be made more
convenient if the health facility is
far away
Equity Accommodates in- and out-of In- and out-of school adolescents In-school adolescents only In- and out-of school adolescents
school adolescents
Community May need intensive mobilization Using same outreach locations as for Schools can help facilitate sensitization Needs comprehensive strategy and
for adolescents to attend, infant vaccination may make and mobilization of parents/communities intense community mobilization
mobilization partnering with communities mobilization easier
Frequency of Continuous, all year round Only when outreach is planned/occurs Requires regular visits to all schools Annual or periodically, depending on
(frequency will depend on the number of the number of cohorts targeted
vaccination school classes targeted for vaccination)
Vaccine supply Requires continuous available Challenging to know exact number of Enrolment lists can facilitate estimate of Large volume of vaccine needed over
supply with other routine vaccines adolescents who will attend outreach needed vaccine and related supplies short duration
(ensure planning and placement of session Distribution challenges - must be
orders) able to redistribute/ resupply quickly
during campaign
Cold chain Cold chain available at health Vaccine carriers must be prepared to Vaccine carriers must be prepared to Vaccine carriers must be prepared to
centre maintain cold chain maintain cold chain maintain cold chain as the large
management volume of vaccine required at one
28
time may be challenging to store in
the existing cold chain.
Integration with With HPV (and other vaccines); With HPV; possible co-delivery with With HPV; possible co-delivery with Integrate with other vaccination
may help to strengthen interventions of short duration short-duration interventions possible; campaigns or age-appropriate
other Adolescent Friendly Health synergistic opportunities interventions, e.g. deworming
interventions Services Integration with school health platform
may be possible
Monitoring Tally sheets and registers Tally sheets, registers and HBRs available Tally sheets, registers and HBRs available Need to consider volume and how to
available, as well as home-based and taken to the outreach and taken to the school best record doses given, in tally
records (HBRs) Persons asked to bring their HBRs, as Persons asked to bring their HBRs, as sheets as well as HBRs
available available
School enrolment lists can facilitate
identifying and recording vaccinated
students.
Cost Low, when supported by national Medium-High (depends on use of Medium-high (depends on school Generally high (but for small
health budget existing outreach sessions that are enrolment, depends on use of existing populations may be cost-effective),
already planned and funded in health outreach sessions that are already needs to include expenses for per-
budget) planned and funded or if additional diems and transport.
resources are required for healthcare
workers to travel to schools)
Note: A combination of strategies may be needed to achieve high coverage while optimizing resources and to include out-of-school/hard-to-reach/vulnerable
targeted adolescents. Strategies may also vary throughout a country, based on local/provincial/district characteristics or opportunities.
29
Is it necessary to introduce all three TTCV booster doses into the
immunization schedule together at the same time?
For sustainability, and to develop early long-term Benefit of vaccinating early

protection, countries should strive towards a
routine childhood vaccination schedule that • Studies show that children
develop higher antibody levels
provides 6-doses of TTCV by adolescence. This will
than adults.
provide protection throughout the reproductive • The immune response to TTCVs
years thereby sustaining MNTE, and beyond. tends to decrease with age.
However, it is recognized that it may be difficult for many national immunization
programmes in low-income countries to rapidly introduce all three of the TTCV booster
doses at the same time, particularly if their programmes do not already have policies and
activities in place to vaccinate school-age children. Countries may build their tetanus
schedules incrementally, one booster at a time, also considering other new vaccine
introductions (e.g. MCV2, HPV) as platforms for efficiently adding a TTCV booster.
Each and every additional booster dose of TTCV in childhood is of benefit. Although tetanus
antibody levels are high after 3 primary TTCV doses in infancy, levels decline over time. A
booster dose in the 2nd year of life rapidly increases antibody levels. Repeat boosting with
two more doses by adolescence elicits a robust humoral immune response lasting decades
(Figure 4).
Figure 4
Antibody response to TT and duration of immunity after 6 properly spaced doses (TO BE REPLACED
WITH NEW GRAPHIC)12
12
Adapted from WHO (2018). The Immunological Basis for Immunization Module 3: Tetanus Update 2018.
Geneva: World Health Organization.
(http://apps.who.int/iris/bitstream/handle/10665/275340/9789241513616-eng.pdf?ua=1, accessed 22
November 2018).
30
What is the catch-up schedule for children >1 year of age or adolescents
who missed or did not complete the primary series of TTCV?
If tetanus vaccination is started >1 year of age (i.e. no primary series received) then only 5
appropriately spaced doses of TTCV are required to obtain long-term protection. The 5-dose
“catch-up” schedule for children >1 year of age, adolescents and adults (including pregnant
women) with no previous immunization against tetanus is the same for males and females
and is as shown in Table 4.
Table 4
Catch-up vaccination schedule for previously unvaccinated and vaccine options according to age
Minimum interval from the most recent dose administered

No. of dose
Vaccine 1st dose 2nd dose 3rd dose 4th dose 5th dose
(age-appropriate)
1–4 years:
DTwP, DTaP, or DT
At least 1
4–7 years: At least 4 At least 6 At least 1
As early as year after
DTwP, DTaP, Td, or weeks after months after year after
possible the 3rd
DT the 1st dose the 2nd dose the 4th dose
dose
˃7 years:
Td or TdaP
The reason that older age groups need only 5 doses for catch up is because the third dose is
given 6 months after the second dose, thereby eliciting a stronger antibody response. In
infants (i.e. <1 year of age) the first three doses are given closer together (i.e. minimum
interval of 4 weeks between doses), mainly to ensure immunity to pertussis and protect
infants who are at risk for complications or death if they get pertussis at such a young age.
Generally, if the country is using a DTP-containing vaccine with a whole-cell pertussis (wP)
component then children up to 7 years of age who are previously unvaccinated would
benefit from receiving a catch-up vaccination with DTwP. Those who are 7 years or older
can receive Td because vaccines containing wP component are not recommended for
those >7 years.
For countries using aP combinations, these can be given to all age groups. Since the duration
of protection of aP against pertussis is shorter than wP, more boosters of aP containing
vaccines may be required.
In some countries of Eastern and Southern Africa, several cases of tetanus following male
circumcision for the prevention of HIV infection have highlighted the tetanus immunity gap
31
in adolescent and adult males13. See Box 9 for vaccination opportunities and guidance
specific for these situations.
Box 9
Voluntary male circumcision (VMMC) for HIV prevention and tetanus vaccination for
adolescent boys and adult males14
WHO/UNAIDS recommends male circumcision as an intervention for HIV prevention in

countries and regions with heterosexual epidemics, where there is high HIV burden and
low male circumcision prevalence, and where there is limited contact with the health
services. VMMC service delivery provides an opportunity to reach adolescent boys and
adult men with relevant services, including vaccination with TTCV.
Methods for male circumcision have different risks for tetanus which should be mitigated.
Several surgical methods are available including conventional and device-based
circumcision.
For conventional surgical male circumcision, depending on the country context and the
individual’s vaccination record, a dose of TTCV may be added at the time of or prior to
surgery. Another dose, with an interval of at least 4 weeks, could be given at the follow-
up visit. The client should be referred to a health facility to receive a third dose 6 months
later.
Circumcision using the elastic collar compression (Day7) method has the greater risk of
tetanus compared to conventional surgery and should be undertaken only if the client has
been adequately protected against tetanus prior to device placement.
• For those not previously vaccinated, 2 doses of TTCV should be administered at least 4
weeks apart, with the second dose at least 2 weeks before placement of the device.
• If an individual has documented evidence of 3 doses received in infancy, and 1 dose
during adolescence or adulthood, a booster dose of TTCV should be given at least 2
weeks before the device placement.
Individuals should be provided with and educated to keep their vaccination record/card.
13
Dalal S, et al. (2016). Tetanus disease and deaths in men reveal need for vaccination. Bulletin of World
Health Organization. 94: 613–621 (www.who.int/bulletin/volumes/94/8/15-166777.pdf, accessed 22
November 2018).
14
WHO (2018). Manual for male circumcision under local anaesthesia and HIV prevention services for
adolescent boys and men. Geneva: World Health Organization
(http://apps.who.int/iris/bitstream/handle/10665/272387/9789241513593-eng.pdf?ua=1, accessed 22
November 2018).
32
What activities need to be undertaken to ensure successful roll out of a
routine childhood 6-dose TTCV schedule?
Expanding the TTCV schedule to include three booster doses requires comprehensive
planning. In many ways, this effort will follow the processes and activities that countries use
for introducing a new vaccine (see Box 10).
Box 10
WHO guidance on new vaccine introduction
Principles and considerations for adding a vaccine to a national

immunization programme: From decision to implementation and
monitoring (2014) – resource document for countries that explains the
principles, issues and processes to be considered when introducing a
new vaccine into a national immunization programme.
www.who.int/immunization/programmes_systems/policies_strategies/vaccine
_intro_resources/nvi_guidelines/en/.
Rather than repeating in detail, some of the key activities and reference to additional
resource materials is summarized below.
Decision-making and policies:

• Involve the National Immunization Technical Advisory Group (NITAG) or its equivalent.
• Review policies and legislation concerning vaccination of school children.
• Consider consent processes.
• Involve other ministries (e.g. education, finance, etc.).
• Obtain endorsement from inter-agency coordinating committee (ICC) where available,
and engage key stakeholders, such as paediatricians’, midwives’ and nurses’
associations.
• Estimate costs, prepare detailed introduction plan, update cMYP, and secure financial
resources (submit applications to donors for funding, if applicable).
Forecasting and procuring supply:

• Estimate target populations using population data from various sources [UN Population
Division (see Annex 2) school enrolment, census, other programmes, etc.].
• Estimate number of doses and injection equipment needed.
• Verify cold chain capacity and distribution schedule.
• Procure vaccine and injection equipment (using UNICEF Supply Division Procurement
Services if needed).
• Procure tally sheets, registers and home-based records as needed.
33
Microplanning:
• Complete district level microplanning.
• Prepare and compile budgets.
• Develop a plan for using the TTCV booster contacts to provide catch up of previously
missed doses of other childhood vaccines and estimate the supply needs of these other
vaccines.
Recording and reporting:

• Adapt/revise home-based records/immunization cards, recording forms and systems.
Training and supportive supervision:

• Develop training materials and job aids.
• Undertake training of health workers.
• Distribute/communicate any revised policy directives.
• Revise supervision checklist and strengthen supportive supervision.
• Incorporate revised TTCV schedule into training curriculum of academic programmes for
doctors, nurses and other healthcare professionals.
Communications/hesitancy
• Develop a communication plan15 including a crisis management plan16, following
Knowledge, Attitude and Practice (KAP) studies where appropriate (see Box 11).
• Identify target audiences (including media, parents, school teachers, etc.).
• Develop and test key messages (see Box 12).
• Anticipate rumours and proactively address vaccine hesitancy and possible anxiety-
related reactions (see Box 13).
Monitoring and evaluation

• Adapt immunization coverage wall monitoring charts, and monthly coverage reporting
processes to include booster doses of TTCV (see Chapter 5 for more information).
• Review monthly reporting of doses administered and coverage to assess performance
and need for corrective action.
• Consider doing a special post-introduction evaluation (PIE)17, 6-months after
implementation, or include in the next Immunization Programme Review.
15
WHO Regional Office for Europe (2017). New vaccine introduction. Checklist for planning communication
and advocacy. Copenhagen: World Health Organization Regional Office for Europe.
(http://www.euro.who.int/__data/assets/pdf_file/0008/337490/02_WHO_VaccineSafety_SupportDoc_NewVa
ccIntro_Proof8.pdf?ua=1, accessed 22 November 2017).
16
WHO Regional Office for Europe (2017). Crisis communications plan template. Copenhagen: World Health
Organization Regional Office for Europe. (http://www.euro.who.int/__data/assets/pdf_file/0014/333140/VSS-
crisis-comms-plan.pdf?ua=1, accessed 22 November 2018).
17
Given the burden of multiple assessment and review exercises, WHO no longer recommends that a PIE
should be conducted after every new vaccine introduction (unless the vaccine product or strategy is drastically
34
Box 11
Crisis communications plan and vaccine safety
Countries should prepare crisis communication plans that allow for a rapid and effective
response to adverse events following immunization (AEFI), anti-vaccine movements, and
any allegation that can have a negative effect on public acceptance of TTCVs and trust in
the immunization programme.
Countries should have in place the basic elements of a crisis plan, which may include:
• an AEFI committee at different levels which can meet immediately to discuss and
plan action;
• clear channels of communication with various media;
• engaging with credible opinion and traditional leaders to address misconceptions
and rumours;
• training of health workers on inter-personal communication and on how to
communicate with the public about AEFI and safety concerns;
• an AEFI action plan with specific roles for immunization programme partners.
Box 12
Examples of key communication messages on TTCV boosters
• The organism that causes tetanus is present everywhere in the environment.

• Tetanus is deadly at any age and vaccination is the key method for protection.
• TTCV boosters for young children and adolescents are needed to give long-term
protection to girls and boys against tetanus.
• Each additional booster vaccination against tetanus extends protection lasting for
many more years.
• Everyone needs to be protected, but tetanus vaccination is especially important to
prevent newborns and mothers getting tetanus during delivery (use local names for
MNT).
• TTCV is safe and has been used around the world for many decades.
• TTCV boosters are available free of charge at (location) (date, time).
• Three boosters are needed for long-term protection at ages 12–23 months, 4–7 years
and at 9–15 years.
• The government supports TTCV booster vaccination and has added it to the national
immunization schedule.
different from current practice). All programmatic assessments should ideally be combined into one
comprehensive EPI Programme Review and performed only every 3–5 years.
35
Box 13
WHO resources on vaccine safety and AEFI communication
WHO e-Learning Course in Vaccine Safety (2013) – remote

training package developed as a course on Vaccine Safety Basics
to help health workers understand the origin and nature of
adverse events, the importance of pharmacovigilance, and risk
and crisis communication.
Available as CD-ROM, downloadable PDF, and e-learning on:

http://www.who.int/vaccine_safety/initiative/tech_support/ebasi
c/en/.
Vaccine Safety Events: Managing the Communications Response

(2013) – provides practical, informative strategies and tools to
help plan and manage a communications response following a
vaccine-related event in a local community, at the national level,
or beyond.
http://www.euro.who.int/__data/assets/pdf_file/0007/187171/V
accine-Safety-Events-managing-the-communications-
response.pdf.
How to respond to vaccine deniers in public (2016) – based on

psychological research on persuasion, on research in public
health, communication studies and on WHO risk communication
guidelines, this document provides basic broad principles for a
spokesperson of any health authority on how to respond to vocal
vaccine deniers.
http://www.euro.who.int/__data/assets/pdf_file/0005/315761/B
est-practice-guidance-respond-vocal-vaccine-deniers-public.pdf
and http://www.euro.who.int/en/health-topics/disease-
prevention/vaccines-and-
immunization/activities/communication-and-advocacy/facing-
vocal-vaccine-deniers-in-public-debate.
For more resources on building and restoring confidence in vaccines and vaccination in
routine work and in crisis, see Vaccination and Trust Library available online at:
http://www.euro.who.int/en/health-topics/disease-prevention/vaccines-and-
immunization/publications/vaccination-and-trust.
36
3. Antenatal care (ANC) contacts and tetanus vaccination status of
pregnant women

• The role of vaccinating pregnant women and how this will change as countries
establish the 6-dose routine child/adolescent schedule;
• The current WHO recommendations for antenatal care (ANC) contacts;
• How to screen and verify the tetanus vaccination status of pregnant women;
• What records/cards pregnant women need to keep;
• What “Protection at Birth” (PAB) means and why it is important;
• Routine administrative TTCV2+ coverage monitoring.

• Plan how the ANC and EPI programmes can work together to protect against
tetanus;
• Train health workers to screen correctly to determine what dose(s), if any, a
pregnant women needs;
• Improve the use and retention of home-based records/cards;
• Ensure PAB and TTCV2+ coverage monitoring is implemented and calculated
correctly.
37
What is the role of vaccinating pregnant women and how will this change as
countries establish the 6-dose routine child/adolescent schedule?
In order to achieve and sustain MNTE, countries Maternal tetanus: Tetanus

must ensure that at least 80% of pregnant women occurring during pregnancy or
in every district are fully vaccinated against tetanus. within six weeks after any type
Pregnant women can contract tetanus during of pregnancy termination
unclean miscarriage, abortion, and childbirth. (birth, miscarriage, abortion).
Increasingly, as countries implement the routine 6-dose child/adolescent tetanus

schedule, fewer and fewer pregnant women will require tetanus vaccination during their
pregnancy because they will have already been fully protected as children/adolescents.
However, achieving at least 80% coverage of 6 TTCV doses by adolescence in every

district will take time. Because it is essential that every mother and newborn is protected
against tetanus, it will always be necessary for ANC programmes to screen pregnant
women to check that they are fully protected against tetanus, and administer any TTCV
doses needed for long-term protection. It is important that received doses are accurately
recorded on the appropriate home-based card and that their long-term retention is
ensured so that the history of tetanus vaccination can be verified and unnecessary
vaccinations avoided.
TTCVs are safe for pregnant women. There is no evidence of adverse pregnancy
outcomes or risk to the foetus from TTCV vaccination during pregnancy18. TTCVs are also
safe to use in HIV-infected and immunocompromised persons.
Anyone who receives 6 doses of TTCV starting with the primary series in infancy (or
5 doses if first vaccinated after infancy) achieves long-term protection and is
protected against tetanus throughout their adulthood and beyond.
18
WHO (2014). Safety of Immunization during Pregnancy. Geneva: World Health Organization
(http://www.who.int/vaccine_safety/publications/safety_pregnancy_nov2014.pdf, accessed 22 November
2018).
38
What are current WHO recommendations for antenatal care (ANC)
contacts?
Following a comprehensive review of evidence in 2016, WHO issued new recommendations

on ANC19.
WHO now recommends a minimum of eight ANC

contacts, scheduled to take place as follows:
• the 1st contact in the first trimester (up to 12
weeks of gestation);
• two contacts scheduled in the second trimester
(at 20 and 26 weeks of gestation); and
• five contacts scheduled in the third trimester (at
30, 34, 36, 38 and 40 weeks).
It is important that all pregnant women attend an

antenatal clinic or can be reached by health staff in the community. Starting from the first
ANC contact, WHO recommends verifying the TTCV status of pregnant women and
administering TTCV if needed20. See How to screen and vaccinate pregnant women for
protection against tetanus? (page 40) for vaccination schedule for TTCV unvaccinated and
partially vaccinated pregnant women.
For effective implementation, ANC health-care providers need to be trained to screen the
vaccination status of pregnant women and if needed, either refer for appropriate
vaccination, or administer the TTCV themselves. The vaccine, equipment and supplies
(refrigerator, needles and syringes, safety boxes) need to be readily available for provision
of ANC vaccination in the facilities and/or during community outreach.
When a pregnant woman attends an ANC visit, the health worker has an opportunity to:
• explain the advantages and encourage delivery at a health facility;
• reinforce the importance of delivery with skilled health personnel (competent maternal
and newborn health professional) if the childbirth will happen outside of health facility
and provide information on how to access such services;
• explain the principles of clean cord care practices, especially if unsafe practices are
likely;
19
WHO (2016). WHO recommendations on antenatal care for a positive pregnancy experience. Geneva: World
health Organization (http://apps.who.int/iris/bitstream/handle/10665/250796/9789241549912-
eng.pdf?sequence=1, accessed 22 November 2018).
20
Policy-makers in low prevalence/high-income settings may choose not to include tetanus vaccination among
ANC interventions if effective tetanus immunization programmes and good post-exposure prophylaxis exist
outside of pregnancy.
39
• emphasize the importance of timely infant vaccination and communicate the
infant/child vaccination schedule to pregnant women.
If these services are not available or affordable, or if women prefer to deliver at home (non-
facility delivery) without skilled health personnel, health workers should make additional
effort to instruct pregnant women and their family on:
• how to ensure clean and safe childbirth at home
• how to ensure clean and appropriate cord care
• how to avoid harmful cord care practices
• how to recognize complications, especially early signs of tetanus
• when and where to seek care in case of complications.
Additionally, if appropriate and available, provide these women with a clean birth kit (CBK)
and instruct them on how to use it (see What are clean birth kits and childbirth checklists?,
page 54).
Home-based records for pregnant women and their unborn child may be distributed during
ANC contacts and the importance of their retention well explained.
Box 14
WHO resources focusing on a positive pregnancy experience through improved quality of antenatal
care
WHO recommendations on antenatal care for a positive

pregnancy experience (2016) – comprehensive guideline
intended to reflect and respond to the complex nature of the
issues surrounding the practice and delivery of ANC, in
accordance with a human rights-based approach.

www.who.int/reproductivehealth/publications/maternal_peri
natal_health/anc-positive-pregnancy-experience/en/.
40
Antenatal care infographics – part of innovative, evidence-
based approaches to antenatal care, focusing on contacts as an
active connection between a pregnant woman and a health
care provider, to ensure an effective transition of a positive
pregnancy experience to positive labour, childbirth and
motherhood experience.

http://www.who.int/reproductivehealth/publications/materna
l_perinatal_health/ANC_infographics/en/.
How to screen and vaccinate pregnant women for protection against

tetanus?
At the first ANC contact the tetanus vaccination status of pregnant women should be
verified by card or history.
If card and/or history confirm that the pregnant woman is fully protected against tetanus
(i.e. has received 6 TTCV doses in childhood/adolescence, or 5 doses if first vaccinated
after 1 year of age/during adolescence/adulthood, including during previous
pregnancies), then no further vaccination is needed. Vaccination of a “fully protected”
pregnant woman (or any individual) should be avoided in order to prevent the risk of
increased local reactions caused by pre-existing high levels of tetanus antibodies.
However, it is still very important to record this pregnant woman as “fully vaccinated
with TTCV” on her home-based record or ANC card and in the immunization register,
even though she did not receive any TTCV doses in the current pregnancy.
If the pregnant woman does not have a card and the history seems unreliable, her
vaccination status is considered unknown. Pregnant women with unknown vaccination
status and those who have not been previously vaccinated should receive at least 2 TTCV
doses as early as possible, with an interval of 4 weeks between the doses. Administer the
2nd dose at least 2 weeks before birth to allow for adequate immune response. Further
doses of TTCV should be administered as shown in Table 5.
If the pregnant woman has received 1–4 doses of TTCV in the past, administer one dose
of TTCV before delivery (see Table 5). For various training scenarios see Annex 3.
If the pregnant woman can confirm by card that she has received some but not all the
needed doses of TTCV, provide vaccination following the schedule for partially
41
vaccinated women shown in Table 6. The last dose of TTCV must be administered at least
two weeks before delivery.
If the woman underwent miscarriage or unsafe abortion, and if she is considered
unprotected against tetanus, vaccinate her immediately as shown in Table 5, to protect
her against future tetanus risks.21
Table 5
TTCV vaccination schedule for WRA and pregnant women with unknown vaccination status or
without previous exposure to TTCV22
Expected duration of
Dose of TTCV When to give
protection
At first contact or as early in pregnancy None
TTCV 1
as possible
At least 4 weeks after TTCV1 (at the 1-3 years
TTCV 2
latest 2 weeks prior to birth)
At least 6 months after TTCV2, or during At least 5 years
TTCV 3
subsequent pregnancy
At least 1 year after TTCV3, or during At least 10 years
TTCV 4
subsequent pregnancy
At least 1 year after TTCV4, or during For all childbearing age
TTCV 5
subsequent pregnancy and much of adulthood
Table 6
TTCV vaccination schedule for partially vaccinated pregnant women23
Recommended TTCV doses
Previous vaccinations
Age of last Later (with
(from vaccination At present ANC
vaccination interval of at
record) contact/pregnancy
least one year)
Infancy 3 TTCV primary doses 2 doses of TTCV 1 dose of TTCV
(minimum 4 week
interval between
doses)
Early 3 TTCV primary doses + 1 dose of TTCV 1 dose of TTCV
childhood/ 1 booster
school age (total of 4 TTCV doses)
School age 3 TTCV primary doses + 1 dose of TTCV None (fully
2 boosters protected)
(total of 5 TTCV doses)
Adolescence 3 TTCV primary doses+ None (fully protected) None (fully
3 boosters protected)
21
In addition, offer prophylaxis with human tetanus immune globulins (TIG) if the wound is large and possibly
infected with soil or unclean instruments. A single intramuscular dose is recommended as soon as possible. TIG
should be readily available in all countries.
22
WHO (2006). Standards for maternal and neonatal care. Geneva: World Health Organization
(http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/immunization_tetanus.pdf,
accessed 22 November 2018).
23
42
(total of 6 TTCV doses)
All doses given should be properly recorded in the home-based record or

ANC/maternal health card and in the standard facility register and tally sheet. Accurate
recording by dose number (i.e. TTCV2, TTCV3, etc.) is important so that repeated
unnecessary vaccinations can be avoided.
Maternal and neonatal tetanus can be

If a case of NT is identified, the mother
prevented if:
should receive one dose of TTCV as soon as
possible, and the infant should be treated 1. Women of reproductive age are fully
according to national guidelines (see Annex 1 vaccinated against tetanus before they
for more information). A second dose of TTCV become pregnant.
should be given to the mother at least 4
weeks after the first, and the third dose at 2. Pregnant women are screened for
least 6 months after the second. Other un- or protection against tetanus and vaccinated
under- vaccinated women living in the same with TTCV as appropriate.
area should be identified and vaccinated as 3. Clean practices are used during birth
appropriate (see Table 5). All cases of NT and in the care of infant’s umbilical cord.
should be recorded and reported to the
district authority, and all NT cases from low-
risk areas should be investigated.24
In countries which have not achieved MNTE status, the “high-risk” approach should be
part of the elimination strategy. This entails coordinating three rounds of vaccination
campaigns25 and targeting all WRA in high-risk districts to provide 3 doses of TTCV,
irrespective of previous vaccination status. The interval between rounds 1 and 2 (i.e.
TTCV doses 1 and 2) should be at least 4 weeks, and between rounds 2 and 3 (i.e. TTCV
doses 2 and 3) at least 6 months. Ensuring clean birth and cord care practices are
essential complementary activities.26
24
WHO (2006). Standards for maternal and neonatal care. Geneva: World Health Organization
(http://www.who.int/reproductivehealth/publications/maternal_perinatal_health/immunization_tetanus.pdf ,
25
For more on campaigns see Field Guide: WHO (2016). Planning and Implementing High-Quality
Supplementary Immunization Activities for Injectable Vaccines. Geneva: World Health Organization
(https://www.who.int/immunization/diseases/measles/SIA-Field-Guide.pdf, accessed 23 January 2019).
26
43
What records/cards do pregnant women need to keep?
In many countries, women are given their own home-based record (HBR) or case notes
to carry during pregnancy. These may be paper (e.g. card, journal, handbook) or in
electronic format (e.g. memory stick), and women are expected to safeguard and bring
them to all health visits.
In maternal and child health, the HBR can take various forms such as antenatal care
records, vaccination cards, child health booklets, and antenatal and child health books.
HBR or case notes contain patient data which facilitates access to women’s medical
records when needed (e.g. if women change health-care provider, in case of emergency,
etc) and may serve as important data collection and surveillance tools. Depending on the
design and content, they can also be an effective tool to improve health awareness and
client– health care provider communication (e.g. reminders about next appointments).
In some countries, TTCV vaccination of pregnant women is recorded in the same
booklet/record used for the child’s vaccination. In these instances, the mother/child
vaccination record is given to the mother at the first ANC contact and she is instructed to
keep and use it for her newborn child’s vaccination history.
Promote lifetime vaccination records
Permanent, lifetime vaccination cards should be given to every woman who receives
TTCV vaccination. The lifetime cards help health workers schedule vaccination
appointments correctly and avoid giving women too many (or too few) vaccines. It is
important that women understand that the record is valuable and should be kept
safely. For example, make sure health workers ask women for their vaccination cards
or home-based record every time they come for a health service as a means of
reinforcing their importance.
For more information on HBR for maternal, newborn and child health and
implementation recommendations see Box 8 and
http://www.who.int/maternal_child_adolescent/documents/home-based-records-
guidelines/en/.
44
What does “protection at birth” (PAB) mean and why is it important?
Maternal tetanus immunization leads to the production of antibodies and trans-placental

transfer of these to the developing foetus. Because this process of passively acquiring
maternal antibodies is highly efficient, the infant usually has a serum tetanus antibody
concentration at birth greater than, or equal, to that of the mother27. In this way,
through maternal vaccination, both mother and infant are protected from tetanus
occurring during the first few months after
birth. Protection at birth (PAB) against tetanus
A birth is considered protected against

Protection at birth (PAB) is a monitoring
tetanus when occurring during the period
method to determine whether a birth was of protection conferred by the maternal
protected against tetanus, based on written immunization status.
maternal records and/or questioning the
mother (mother’s recall) about the number
and timing of TTCV doses she had previously received.
Only valid doses (at least two), or those given with the minimum required time intervals
between doses, are to be counted. A birth is considered protected if it occurred within
the duration of protection offered by the last valid dose (see Table 7). TTCV doses
received by mothers during childhood are included only if documented in paper or
electronic records (e.g. infant or school vaccination records).
Table 7
Protection at birth based on maternal vaccination history (birth is PAB or considered protected if
it occurred within the duration of protection offered by the last tetanus vaccine dose)
Cumulative number of Minimal interval Duration of protection from

TTCV doses administered between doses to be receipt of last dose
to mother considered valid (PAB status)
TTCV2 4 weeks 3 years
(PAB if birth within 3 years)
TTCV3 6 months 5 years
TTCV4 1 year 10 years
TTCV5 1 year Much of adulthood
(PAB for all subsequent births)
27
Wilcox CR, et al. (2017). Factors affecting FcRn-mediated transplacental transfer of antibodies and
implications for vaccination in pregnancy. Frontiers in Immunology. 8:1294
(https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5671757/, accessed 22 November 2018).
45
If a birth was assessed as unprotected, the mother should receive a dose of TTCV during
that visit and should be followed up with a subsequent TTCV dose(s) if needed, thereby
protecting future pregnancies. The same applies for mothers whose children were
protected at birth but who remain eligible for additional TTCV doses in order to be fully
vaccinated and protected.
How is protection at birth (PAB) implemented, recorded, and coverage calculated?

WHO recommends that PAB status is assessed and recorded to estimate protection
against tetanus in pregnant women. Together with records on facility-based deliveries (if
available), PAB coverage can be used as a proxy marker to assess the district level risk of
MNT.
Traditionally, PAB has been assessed and recorded at the first vaccination contact for the
new-born baby/infant, usually at the Penta1/DPT1 visit. However, all post-natal care
visits (currently recommended at 24 hours, day 3, and between 7–14 days and 6 weeks
after delivery) present an opportunity to check PAB. With the increased integration of
maternal, post-natal and vaccination services there are other contact opportunities
where PAB status could be assessed and recorded (see Table 8). PAB status can be
recorded in the home-based record, ANC card, child’s vaccination card, and tally sheets.
Table 8
Opportunities to implement assessment and recording of PAB status
Contact to
assess/record Considerations
PAB
At birth • Best for countries with high proportion (%) of facility-based
deliveries.
• Requires collaboration between maternal and immunization
services.
• PAB could be recorded in mother’s ANC card, or integrated maternal
and child card, or child immunization card, and recorded on facility
registers/tally sheets.
• Especially appropriate if Hep B and BCG are given at time of birth
(along with vaccination card).
1st postnatal • Would capture all infants born (non-facility and facility) as mother is
contact – required to come to the health facility after birth, but requires strong
ideally 24 hours postnatal programme implementation and access to services to
after birth28 achieve high coverage.
(e.g. HepB birth • Requires collaboration between maternal and immunization
dose) services.
28
WHO (2013). WHO recommendations on postnatal care of mother and newborn. Geneva: World Health
Organization
(http://apps.who.int/iris/bitstream/handle/10665/97603/9789241506649_eng.pdf;jsessionid=CA66BC00A6F6
8EEE2B597CC699361998?sequence=1, accessed 22 November 2018).
46
• PAB could be recorded in mothers ANC card, or integrated maternal
and child card, or child immunization card if it has been given, and
recorded on facility registers/tally sheets.
First • Vaccination services usually have high attendance (high Penta 1
vaccination coverage).
contact of the • Easy to do and record (cards and registers and tally sheets available)
infant both for facility-based and outreach vaccination sessions.
(Penta1/DTP1) • Does not require collaboration with other programmes.
PAB coverage is the proportion of births in a given year that can be considered as having
been protected against tetanus as a result of maternal immunization.
PAB coverage is calculated as follows:
Total number of infants who were protected

against neonatal tetanus by their mother ′ s TTCV status
%𝑃𝐴𝐵 = x 100
Total number of live births
Annex 4 provides an overview of how to implement the PAB method in practice and
examples of tools (i.e. reporting form, NT protection calculator, etc.).
What is routine administrative TTCV2+ coverage monitoring?
Experience has shown that aggregated administrative monitoring of the second or

subsequent dose of TTCV (TTCV2+) coverage of pregnant women is difficult to do
accurately, particularly at the national level, unless countries have electronic registers.
Emphasis should be on making sure that doses of TTCV are recorded on home-based
records for maternal, newborn and child health, and that these records/cards are
retained over the long term or at least through reproductive age for women29 .
Good recording of maternal and infant TTCV doses will enable PAB to be accurately
monitored (see What does “protection at birth” mean and why is it important?, page 44).
Immunization coverage surveys (e.g. DHS, MICS) can be used to periodically assess
TTCV2+ coverage in mothers who had a pregnancy in the past 12 months, and can also
be used to validate PAB coverage.
29
WHO (2018). WHO recommendations on home-based records for maternal, newborn and child health.
Geneva: World Health Organization (http://www.who.int/maternal_child_adolescent/documents/home-
based-records-guidelines/en/, accessed 22 November 2018).
47
In countries that continue with routine administrative monitoring of TTCV2+ coverage, as
a refinement WHO recommends that the numerator includes those pregnant women
who are already fully protected through previous TTCV vaccination to avoid
underestimation.
TTCV2+ coverage for pregnant women is the proportion of pregnant women in a given year
who are fully vaccinated for this pregnancy (who received TT2, TT3, TT4, or TT5 dose),
INCLUDING those pregnant women already fully protected/vaccinated against tetanus prior
to the pregnancy.
%TTCV2+ coverage of pregnant women =
𝑇𝑜𝑡𝑎𝑙 𝑛𝑜. 𝑜𝑓 𝑤𝑜𝑚𝑒𝑛 𝑣𝑎𝑐𝑐𝑖𝑛𝑎𝑡𝑒𝑑 𝑤𝑖𝑡ℎ 2 𝑜𝑟 𝑚𝑜𝑟𝑒 𝑑𝑜𝑠𝑒𝑠 𝑜𝑓 𝑇𝑇𝐶𝑉 𝑑𝑢𝑟𝑖𝑛𝑔 𝑝𝑟𝑒𝑔𝑛𝑎𝑛𝑐𝑦
+ 𝑝𝑟𝑒𝑔𝑛𝑎𝑛𝑡 𝑤𝑜𝑚𝑒𝑛 𝑎𝑙𝑟𝑒𝑎𝑑𝑦 𝑓𝑢𝑙𝑙𝑦 𝑝𝑟𝑜𝑡𝑒𝑐𝑡𝑒𝑑, 𝑖𝑛 𝑎 𝑦𝑒𝑎𝑟
=
𝐸𝑠𝑡𝑖𝑚𝑎𝑡𝑒𝑑 𝑛𝑢𝑚𝑏𝑒𝑟 𝑜𝑓 𝑝𝑟𝑒𝑔𝑛𝑎𝑛𝑡 𝑤𝑜𝑚𝑒𝑛 𝑑𝑢𝑟𝑖𝑛𝑔 𝑡ℎ𝑒 𝑦𝑒𝑎𝑟30
ANC cards, immunization registers and tally sheets should be adapted to include a
column for “Fully Immunized Prior to the Pregnancy”. For an example of a tally sheet see
Annex 5.
30
For information on how to obtain estimates of national numbers of births see WHO Working Draft (2015) of
Assessing and improving the accuracy of target population estimates for immunization coverage. Geneva:
World Health Organization
(http://www.who.int/immunization/monitoring_surveillance/data/Denominator_guide.pdf?ua=1, accessed 22
November 2018).
48
4. Ensuring clean birth and umbilical cord care practices

• Why clean birth and umbilical cord care are important for MNTE
• How can clean birth and clean cord care practices be achieved
• What practices ensure a clean birth and cord care
• What are clean birth kits (CBK) and childbirth checklists.

• Plan and improve birth practices so that there is no risk of tetanus and other
causes of perinatal mortality;
• Train health workers;
• Develop information, education and communication (IEC) materials for women
and communities.
49
Why are clean birth and umbilical cord care important for MNTE?
A clean birth, along with appropriate hygienic practices post-childbirth, can effectively
reduce risks of tetanus, even if maternal TTCV coverage is suboptimal in a country. Clean
birth can also reduce other causes of perinatal mortality such as infections other than
tetanus that could result in neonatal sepsis.
A newly cut umbilical cord can be a pathway for local and invasive infections. Localized
infection of the umbilical stump (omphalitis) may progress beyond the subcutaneous
tissues, involve abdominal wall muscles, the umbilical and portal veins, and lead to systemic
sepsis which, if untreated, has a high case-fatality rate.
In many cultures around the world there is a desire to actively care for the umbilical cord of
the newborn, irrespective of whether they are born at home or in health-care facilities.
These traditional practices vary by country or cultural groups within a country, and include
application of a wide range of substances31 such as:
• Oils, herbs/spices/plants;
• Minerals and powders;
• Animal dung;
• Water;
• Bodily fluids;
• Food;
• Heat (e.g. hot knife, steam, burning);
• Personal care or medical substances (e.g. creams, ointments, toothpaste, alcohol,
iodine, herbal medicines, etc.);
• Other substances (e.g. burnt cotton, shells, tar, fish bones, crushed wasp nests, etc.).
Application of substances to the stump is not indicated because it delays the physiological
drying of the umbilical cord stump and can be harmful. In settings with poor hygiene,
adequate cord care practices for the newborn, especially if provided by skilled health
personnel, has the potential to avoid preventable neonatal deaths. Evidence suggests that
clean birth practices can reduce the incidence of NT by 55–99%.32 See WHO
31
Coffey PS, Brown SC (2017). Umbilical cord-care practices in low- and middle-income countries: a systematic
review. BMC Pregnancy and Childbirth 17:68
(https://bmcpregnancychildbirth.biomedcentral.com/track/pdf/10.1186/s12884-017-1250-7, accessed 11
January 2019).
32
WHO (2016). Report of the SAGE working group on maternal and neonatal tetanus elimination and broader
tetanus prevention, September 2016. Geneva: World Health Organization
(http://www.who.int/immunization/sage/meetings/2016/october/1_Report_of_the_SAGE_Working_Group_o
n_Maternal_and_Neonatal_Tetanus_27Sep2016.pdf, accessed 11 January 2019).
50
recommendation for cord care in section What practices ensure a clean birth and cord
care?, page 52.
How can clean birth and clean cord care practices be achieved?
Having skilled health personnel is key to ensuring clean birth and cord care (see
Box 15 for definition of skilled health personnel).
Increasing the number of deliveries with a competent maternal and newborn health
professional in order to reduce maternal and neonatal deaths is a global goal of the Every
Newborn Action Plan (ENAP)33, the Global Strategy for Women’s, Children’s and Adolescent
Health34, the Sustainable Development Goals (SDGs)35, and Ending Preventable Maternal
Mortality (EPMM) Initiative36.
At the community level, skilled health personnel will often be the only qualified and
accredited health care workers with exclusive responsibility for the care of women during
pregnancy, childbirth, and the immediate postnatal period. Others, ranging from traditional
birth attendants (TBAs), nurses to specialist physicians, will certainly contribute to the care
of women and newborns, but none of these will have either the wide-ranging competence
or the mandate for all the tasks the skilled health personnel is required to perform.
Globally the proportion of women giving birth with a competent MNH professional has
increased in the last two decades. However, there are great disparities in coverage and
quality of care between and within countries. Countries are encouraged to ensure, without
delay, that skilled health personnel providing care during childbirth are available to all
pregnant women and newborn.
Box 15
Sustainable Development Goals and definition of by skilled health personnel
33
WHO (2014). Every newborn, an action plan to end preventable deaths. Geneva: World Health Organization
(http://apps.who.int/iris/bitstream/10665/127938/1/9789241507448_eng.pdf, accessed 22 November 2018).
34
Promoting health through the life-course: Commitments to Every Woman Every Child’s Global Strategy for
Women’s, Children’s, and Adolescents’ Health (2016-2030) [website]. Geneva: World Health Organization
(http://www.who.int/life-course/partners/global-strategy/en/, accessed 15 January 2019).
35
Sustainable Development Goals [website]. United Nations
(http://www.un.org/sustainabledevelopment/sustainable-development-goals/, accessed 15 January 2019).
36
WHO (2015). Sexual and reproductive health: Strategies toward ending preventable maternal mortality
(EPMM). Geneva: World Health Organization
(http://www.who.int/reproductivehealth/topics/maternal_perinatal/epmm/en/, accessed 15 January 2019).
51
A critical progress indicator adopted by the Sustainable Development Goals (SDG) and the
Global Strategy for Women's, Children's and Adolescents' Health, 2016-2030 agenda is
the “percentage of births delivered by skilled attendant at birth” (SBA).
WHO, UNFPA, UNICEF, ICM, ICN, FIGO and IPA proposed a revised definition of skilled
health personnel providing care during childbirth (previously referred to as “skilled birth
attendants” or SBAs) in order to standardize and improve the accuracy of measurement37.
Skilled health personnel are competent maternal and newborn health (MNH)
professionals educated, trained and regulated to national and international standards.
They are competent to:
i. Provide and promote evidence-based, human-rights based, quality, socio-
culturally sensitive and dignified care to women and their newborns;
ii. Facilitate physiological processes during labour and delivery to ensure a clean and
positive childbirth experience; and
iii. Identify and manage or refer women and/or newborns with complications.
In addition, as a part of an integrated team of MNH professionals (including midwives,

nurses, doctors, obstetricians, neonatologists, paediatricians and anaesthesiologists), they
perform all signal functions of emergency maternal and newborn care to optimize the
health and well-being of mothers and newborns within an enabling and supporting
environment.
Box 16
WHO publication on skilled health personnel
Definition of skilled health personnel providing care during

childbirth (2018)
This 2018 joint statement by the World Health Organization
(WHO), the United Nations Population Fund (UNFPA), the
United Nations Children’s Fund (UNICEF), the International
Confederation of Midwives (ICM), the International Council of
Nurses (ICN), the International Federation of Gynecology and
Obstetrics (FIGO) and the International Pediatric Association
(IPA) presents the 2018 definition of skilled health personnel
providing care during childbirth, which is revised and refined
definition of the widely used term “skilled birth attendant”
(SBA). Available online at:
http://www.who.int/reproductivehealth/publications/statem
ent-competent-mnh-professionals/en/.
37
WHO (2018). Definition of skilled health personnel proiding care during childbirth. Geneva: World Health
Organization (http://apps.who.int/iris/bitstream/handle/10665/272818/WHO-RHR-18.14-eng.pdf?ua=1,
52
What practices ensure a clean birth and cord care?
A clean birth is a delivery using hygienic practices and attended by competent maternal and
newborn health personnel in a health care facility or at home.
Knowledge about the importance of clean birthing practice has been available for a long
time. In various regions/countries practices may be summarized differently (e.g. ‘three
cleans’38, ‘five cleans’39, ‘six cleans’40) but they all emphasize ensuring clean hands, clean
birth surface and clean cord care (cut, tie and stump).
Clean birth practices should include:

• Clean hands of birth attendant: wash hands with clean water and soap, once before
the delivery and once before cord cutting (see Annex 6).
• Clean delivery surface: use a clean plastic sheet for mothers to lie on during delivery
to maintain clean birth canal and perineum, and to protect the newborn from
potential sources of infection.
• Clean cord cut: use a new razor blade or other new sharp instrument from its
original packing to prevent the transmission of tetanus-causing spores and other
pathogenic organisms via the umbilicus to the infant.
• Clean cord ties: use clean or sterile thread or narrow tape to tie the umbilicus tightly
and keep the stump healthy.
• Clean cord stump care: in high neonatal mortality settings and where locally
recommended for newborns born outside of health facilities, apply chlorhexidine to
the cord stump (see below). For those born in health facilities, dry cord care is
recommended as per national protocol.
Standard precautions and cleanliness as principles of good care should be observed at all
times. These principles are:
1. Wash hands with soap and water
38
WHO Regional Office for the Americas (2005). Neonatal Tetanus Elimination Field Guide. Washington: WHO
Regional Office for the Americas
(http://www1.paho.org/hq/dmdocuments/2011/FieldGuide_NeonatalTetanus_2ndEd_e.pdf, accessed 22
November 2018).
39
WHO Collaborating Centre for Training and Research in Newborn Care (2005). Teaching aids on newborn
care. New Delhi (http://www.newbornwhocc.org/teaching.html, accessed 22 November 2018).
40
The Partnership for Maternal Health (2006). Opportunities for Africa’s Newborns. Geneva: WHO on behalf of
The Partnership for Maternal Health (http://www.who.int/pmnch/media/publications/oanfullreport.pdf,
53
2. Wear gloves (sterile when attending to woman in labour, delivery and immediate
postpartum care; clean when dealing with handling and cleaning instruments, handling
contaminated waste, blood and body fluid spills).
3. Protect yourself from blood and other bodily fluids (wear gloves, long apron, protect your
eyes and mouth).
4. Practice safe sharps disposal.
5. Practice safe waste disposal.
6. Deal with contaminated laundry (do not touch directly clothing or sheets stained with
blood or body fluids).
7. Sterilize and clean contaminated equipment.
8. Clean and disinfect gloves*.
9. Sterilize gloves*.
* Reusing gloves is not recommended. If it is necessary because of limited supply, gloves can
be disinfected by soaking overnight in bleach solution or sterilized by autoclaving.
For updated recommendations relevant to maternal and perinatal health refer to

Pregnancy, Childbirth, Postpartum and Newborn Care: a guide for essential practice (see Box
17).
WHO recommendations on cord clamping and care
WHO recommendations on cord clamping41

• Late cord clamping (performed after one to three minutes after birth) is recommended
for all births while initiating simultaneous essential newborn care.
• Early cord clamping (<1 minute after birth) is not recommended unless the neonate is
asphyxiated and needs to be moved immediately for resuscitation.
WHO recommendations on cord care42

• Daily chlorhexidine (7.1% chlorhexidine digluconate aqueous solution or gel,
delivering 4% chlorhexidine) application to the umbilical cord stump during the first
week of life is recommended for newborns who are born at home in settings with high
neonatal mortality (30 or more neonatal deaths per 1000 live births).
• Clean, dry cord care is recommended for newborns delivered in health facilities and at
home in low neonatal mortality settings. Use of chlorhexidine in these situations may
be considered only to replace application of a harmful traditional substance, such as
cow dung, to the cord stump.
41
WHO (2018). Intrapartum care for a positive childbirth experience. Geneva: World Health Organization
(http://apps.who.int/iris/bitstream/10665/260178/1/9789241550215-eng.pdf?ua=1, accessed 22 November
2018).
42
WHO (2013). Postnatal care of the mother and newborn. Geneva: World Health Organization
(http://apps.who.int/iris/bitstream/10665/97603/1/9789241506649_eng.pdf?ua=1, accessed 22 November
2018).
54
What are clean birth kits (CBK) and childbirth checklists?
Along with training of health workers, media and public health messaging, and community-
based behaviour change and training, one of the approaches to increase uptake of clean
childbirth practices includes the distribution of clean birth kits (CBK).
WHO established the contents of clean birth kits (CBK) and their correct use in the 1990s.
They differ from country to country depending on local guidelines and regulations, and the
contents will also vary depending on where it is intended to be used (i.e. home delivery
without skilled health personnel, home delivery by skilled health personnel, essential
newborn kits for health facilities, essential newborn kits for hospitals, see Table 9).
Mother-held CBKs are highly cost-effective and considered appropriate in conflicts or

complex humanitarian emergencies, or in settings where there is low coverage of facility
births, as long as they are not a disincentive for facility birth.
United Nations Population Fund (UNFPA), WHO and UNICEF have developed essential
reproductive health kits for emergency situations43 designed to respond to three month’s
need for various population sizes and intended for the use of:
• community: kits packaged for individual distribution to pregnant women and kits
with equipment and supplies for skilled health personnel;
• primary health care level: kits with equipment and supplies for essential newborn
care for uncomplicated births, newborn resuscitation, stabilizing newborns with
serious infection prior to referral, and caring for preterm babies; and
• referral hospital level: kits with equipment and supplies to provide comprehensive
emergency obstetric and newborn care at the hospital (e.g. complicated births,
newborn infections, newborn resuscitation, care for preterm babies with
complications.
For detailed information on the contents of the kits, guidance for their use and orders
please see https://www.unfpa.org/resources/humanitarian-emergencies-procurement.
43
UNFPA. Reproductive health kits management guidelines for field offices. United Nations Population Fund
(https://www.unfpa.org/resources/reproductive-health-kits-management-guidelines-field-offices, accessed 15
January 2019).
55
Table 9
Example of essential supplies for clean birth and newborn care44,45
Where? What is needed? Who uses it?

Plastic sheet, soap, disposable razor
blade, cord tie, cotton cloth ‘tetra’,
Clean birth kit for home The person attending
gloves, plastic bag for disposal of
delivery without skilled birth when there is no
placenta, pictorial instruction for use
health personnel skilled health personnel
leaflet, pictorial leaflet on maternal
and newborn danger signs
The above, plus protective apron and
Essential newborn kit for
mask, portable weighing scale, Skilled health
home delivery by skilled
essential medicines, bulb syringe or personnel
home personnel
portable suction unit
Essential clean birth and
Medical devices, delivery set, suture
newborn kits for primary Skilled health
set, sterilization kit, lighting,
health facilities and personnel and doctors
medicines, treatment guidelines
referral hospitals
Where permitted by local regulations, individual clean birth kits for home delivery may also
include44:
• The antiseptic chlorhexidine for newborn skin washing and umbilical cord cleaning.
In high mortality settings, chlorhexidine has been shown to reduce newborn deaths
by as much as 23 percent when applied within the first 24 hours of birth.
• Misoprostol pills, a uterotonic drug which contracts the uterus, can help to prevent
excessive bleeding after delivery.
To ensure a high-quality of care of births in health facilities, in 2016 WHO developed quality
of care standards which define the requirements. Accompanying these standards are a
WHO Safe Childbirth Checklist and an Implementation Guide which are designed as tools to
improve the quality of care provided to women giving birth in health facilities (see Box 17).
All of these materials support the implementation of clean birth and cord care practices.
44
The Partnership for Maternal, Newborn and Child Health (2006). Opportunities for Africa’s newborns:
practical data, policy and programmatic support for newborn care in Africa. World Health Organization on
behalf of The Partnership for Maternal, Newborn and Child Health
(http://www.who.int/pmnch/media/publications/oanfullreport.pdf, accessed 22 November 2018).
45
UNFPA (2011). Inter-agency reproductive health kits for crisis situations. New York. United Nations
Population Fund, Humanitarian Response Branch (https://www.unfpa.org/sites/default/files/resource-
pdf/RH%20kits%20manual_EN_0.pdf, accessed 22 November 2018).
56
Box 17
Resources on pregnancy, childbirth and newborn care
Pregnancy, Childbirth, Postpartum and Newborn Care: A

guide for essential practice (2015) – compiles all the
updated norms and standards that enable health care
workers to provide high-quality, integrated care during
pregnancy, childbirth and after birth to both mothers and
newborns. The recommendations are specifically for skilled
attendants working at the primary health-care level, either
at the facility or in the community. The guide can be
adapted to local needs and resources.
http://apps.who.int/iris/bitstream/10665/249580/1/97892
41549356-eng.pdf?ua=1.
Managing complications in pregnancy and childbirth: a
guide for midwives and doctors (2nd edition, 2017) – a
manual for midwives and doctors at the district hospital
who are responsible for the care of women with
complications of pregnancy, childbirth or the immediate
postpartum period, including immediate problems of the
newborn.
Avalable online at:
http://apps.who.int/iris/bitstream/handle/10665/255760/9
789241565493-
eng.pdf;jsessionid=7B0C6E2929C8588C0E1C2D5ECF71CBB5
?sequence=1.
Early essential newborn care clinical practice pocket guide

(2014) – is a good example of a user-friendly guide
providing evidence-based protocol to essential newborn
care focusing on the first hours and days of life, developed
in the WHO Western Pacific Region.
http://iris.wpro.who.int/bitstream/handle/10665.1/10798/
9789290616856_eng.pdf;jsessionid=C0109A4E43F771350C
03604ADCF32CAA?sequence=3.
WHO recommendations: intrapartum care for a positive

childbirth experience (2018) – consolidated new and
existing WHO recommendations, intended to inform the
development of relevant national- and local-level health
policies and clinical protocols, and to ensure good-quality
and evidence-based care irrespective of the setting or level
of health care.
789241550215-eng.pdf?sequence=1.
57
WHO recommendations on postnatal care of the mother
and newborn (2013) – guidelines that address timing,
number and place of postnatal contacts, and content of
postnatal care for all mothers and babies during the six
weeks after birth. Primarily intended for health
professionals who are responsible for providing postnatal
care to women and newborns, but can be included in job
aids and tools for both pre- and in-service training of health
professionals.
89241506649_eng.pdf?sequence=1.
The Safe Childbirth Checklist (2015) – an organized list of

evidence-based essential birth practices targeting major
causes of maternal and neonatal deaths and intrapartum-
related stillbirths. The Checklist may need to be adapted to
reflect the local context and/or national guidelines and
protocols. An Implementation Guide for health facilities
has been developed to help birth attendants and health-
care leaders successfully launch and sustain use of the
WHO Safe Childbirth Checklist.
http://www.who.int/patientsafety/implementation/checkli
sts/childbirth/en/.
Standards for improving quality of maternal and newborn

care in health facilities (2016) – include eight domains of
quality of care that should be assessed, improved and
monitored within the health system.
789241511216-eng.pdf?sequence=1.
58
Inter-Agency Reproductive Health Kits for Crisis Situations
(2011) – manual which provides information on
procurement procedures and contents of standardized
emergency kits designed for worldwide use, pre-packed
and kept ready for immediate dispatch in crisis situations.
https://www.unfpa.org/sites/default/files/resource-
pdf/RH%20kits%20manual_EN_0.pdf.
Newborn health in Humanitarian Settings: Field Guide

(2018) – provides essential guidance and tools to health
staff involved in designing, managing, monitoring and
evaluating newborn health services within humanitarian
settings.
https://www.healthynewbornnetwork.org/resource/newbo
rn-health-humanitarian-settings-field-guide/.
59
5. Tetanus surveillance

• What is tetanus surveillance and why it is necessary
• WHO recommended standards for tetanus surveillance.

• Establish reliable tetanus surveillance systems
• Monitor that MNTE is achieved and sustained.
60
What is tetanus surveillance and why is it necessary?
Tetanus surveillance is the systematic, timely, and continuous collection, analysis and
interpretation of epidemiological data on tetanus cases, linked with timely dissemination of
the results so that appropriate action can be taken to control or prevent further cases of
tetanus.
Many countries have regulations for mandatory reporting of a list of notifiable diseases,
tetanus being one of these. Surveillance reports should distinguish and separately
categorize cases of neonatal (aged 0–28 days) and non-neonatal (aged >28 days) tetanus
(see Table 10 for case definitions).
Surveillance for neonatal tetanus

A key objective of neonatal tetanus surveillance is to detect cases of NT towards monitoring
achievement and maintenance of MNTE, defined as less than one NT case per 1 000 live
births annually in every district or equivalent administrative unit.
61
NT surveillance data (or a lack thereof) are used to identify areas and sub-populations at
high-risk for NT and to guide an effective response. High-quality surveillance data, along
with other key programme indicators, at the national and subnational (i.e. district) levels,
enables monitoring of the impact of interventions, and are necessary to identify areas of
increased risk for MNT and to target interventions to maintain elimination.
Surveillance for non-neonatal tetanus

The objective of surveillance for non-NT is to monitor disease burden and changing
epidemiology over time in order to assess the impact of vaccination and to identify gaps in
the immunization programme and health systems in general.
Information from non-NT surveillance should be used to tailor strengthening of routine

immunization services and optimize strategies and vaccination schedules, including
introduction and timing of booster doses. It can also be used to identify clustering of
tetanus cases warranting investigation. Finally, rapid detection of cases can help save lives,
i.e. through initiating receipt of proper treatment, including administration of antitoxin.
Table 10
WHO case definitions for tetanus
Neonatal tetanus (NT), Non-neonatal tetanus

Maternal tetanus
aged 0-28 days (non-NT), aged ˃28 days
Suspected case: Suspected case is any case Tetanus occurring during
—any neonate who could suck with acute onset of at least pregnancy or within 6 weeks
and cry normally during the first 2 one of the following signs: after any type of pregnancy
days of life and developed — trismus (lockjaw) termination (birth,
tetanus-like illness or death — risus sardonicus miscarriage or abortion)46.
between 3 and 28 days of age; (sustained spasm of the
OR facial muscles)
— any neonate who died of an — generalized muscle
unknown cause during the first spasms (contractions).
month of life.
46
It includes postpartum or puerperal tetanus resulting from septic procedures during delivery, postabortal
tetanus resulting from septic abortion, and tetanus incidental to pregnancy resulting from any type of wound
during pregnancy.
62
Confirmed case: any suspected Confirmed case: suspected
case found to have all three of the case clinically confirmed as
following: tetanus by physician/trained
—normal ability to suck and cry clinician.
during the first 2 days of life; AND
—could not suck normally
between 3 and 28 days of age;
AND
—developed muscle stiffness
and/or spasms (jerking).
Importance of accurate and complete reporting of non-neonatal tetanus (non-NT)

surveillance for MNTE
Surveillance for non-neonatal tetanus can detect cases of maternal tetanus. However, in
most countries non-NT surveillance occurs through aggregate reporting which lacks
specific information (i.e. age, sex, pregnancy status) to distinguish maternal tetanus. If
country programmes decide that maternal tetanus is of special priority, reports of
maternal tetanus should be handled similarly to those of neonatal tetanus.
What are the WHO recommended standards for tetanus surveillance?
In 2018, WHO published an updated second edition of Surveillance standards for vaccine-
preventable diseases (see
Box 18). This document provides surveillance standards (see
Table 11) and performance indicators for both NT and non-NT surveillance, and detailed
guidance for surveillance activities including:
• case detection
• case definitions and final classification
• case investigation, public health response and clinical case management
• data elements for collection, as well as reporting, analysis, and use
• surveillance performance indicators.
63
Countries may adapt these standards based on local epidemiology, policy, disease control
objectives and strategies. Relevant extracts are provided in Annex 7 for NT surveillance and
in Annex 8 for non-NT surveillance.
Box 18
WHO resources on vaccine-preventable disease surveillance
Surveillance standards for vaccine-preventable diseases,

second edition (2018) – provides NT and non-NT
surveillance standards and detailed guidance for
surveillance activities.
http://www.who.int/immunization/monitoring_surveillanc
e/burden/vpd/standards/en/.
Neonatal tetanus surveillance standards available at:

e/burden/vpd/WHO_SurveillanceVaccinePreventable_14_N
eonatalTetanus_R1.pdf?ua=1.
Non-neonatal tetanus surveillance standards available at:
e/burden/vpd/WHO_SurveillanceVaccinePreventable_15_N
on_neoTetanus_R1.pdf?ua=1.
Making disease surveillance work (2008) – Module 8 of

WHO training for mid-level managers series provides the
basic concepts of surveillance and explains in practical
terms how to manage a surveillance system for vaccine-
preventable diseases.
http://apps.who.int/iris/bitstream/handle/10665/70184/W
HO_IVB_08.08_eng.pdf?sequence=8.
Immunization in practice: a practical guide for health staff

(2015 update), Module 6: Monitoring and surveillance –
explains how to collect and report data for the monitoring
of immunization services and the surveillance of vaccine-
preventable diseases.
789241549097_eng.pdf?sequence=1&isAllowed=y.
64
Table 11
WHO recommended surveillance standards for tetanus
Neonatal Tetanus (NT) Non-Neonatal Tetanus (Non-NT)
The minimal recommended standard: The minimal recommended standard:

Nationwide, case-based surveillance (meaning Nationwide, surveillance with aggregate routine
every suspected NT case should be investigated reporting from inpatient facilities and investigation
and classified as confirmed or discarded). of any unusual disease clusters.
NT surveillance is population-based and includes Non-NT surveillance is population-based and

all neonates aged 0–28 days. includes all persons aged >28 days.
Laboratory confirmation is not an aspect of NT Laboratory confirmation is not an aspect of non-NT

surveillance, as the basis of tetanus diagnosis is surveillance, as the basis of tetanus diagnosis is
clinical rather than laboratory-based. clinical rather than laboratory-based.
Enhanced surveillance for non-NT:

• Case-based surveillance.
• Either nationwide or sentinel surveillance is
advised depending on the local context (public
and private referral hospitals with intensive
care capacity located in areas with high non-NT
burden).
Linkages to other surveillance Linkages to other surveillance

• Ideally, NT surveillance is linked with active • Ideally, non-NT surveillance is linked with
surveillance for AFP and measles-rubella, aggregate surveillance systems for other
and routine aggregate surveillance for “zero diseases through systems such as IDSR and
reporting” as part of Integrated Disease Early Warning, Alert and Response Network
Surveillance and Response (IDSR). (EWARN).
• Linkage to vital event surveillance and • In some cases, HMIS reporting may be used for
neonatal death surveillance47 may be useful facility-based aggregate reporting of non-NT
for increasing NT surveillance sensitivity and cases.
helping to conserve resources. • Linkage to maternal death surveillance and
response (MDSR) and other maternal child
health post-partum surveillance systems may
be relevant in some countries.
47
WHO (2016). Making every baby count: audit and review of stillbirths and neonatal deaths. Geneva: World
Health Organization (http://apps.who.int/iris/bitstream/handle/10665/249523/9789241511223-
eng.pdf?sequence=1, accessed 22 November 2018).
65
6. Monitoring & Evaluation (M&E)

• What monitoring and evaluation (M&E) is required for tetanus vaccination;
• How to periodically assess if MNTE status is sustained;
• What to do if M&E and/or periodic assessment of MNTE finds that elimination
status is at risk.

• Design/adapt recording and monitoring tools for tetanus vaccination, including
boosters;
• Plan and conduct a post-validation assessment of MNTE to ensure it is sustained.
66
What monitoring and evaluation is required for tetanus vaccination?
A successful monitoring and evaluation system for tetanus vaccination consists of:
1. continuous programmatic monitoring that provides information on implementation
performance of tetanus vaccination (i.e. vaccine supply/stock, number of doses
administered, coverage of 3 primary infant doses and 3 booster doses, TTCV2+, PAB,
AEFI reporting, etc.), and
2. periodic assessment to check that MNTE status is maintained.
These two activities are interlinked and will be explained in this chapter. Reliable disease
surveillance data (described in Chapter 5) provide an important complement to
programmatic monitoring and evaluation, as it confirms the impact of the programme.
67
What is most important is that countries (especially those that achieved MNTE by
conducting TTCV campaigns for women of reproductive age in high-risk districts) recognize
that even though they validated MNTE, strong surveillance and constant attention to TTCV
protection levels (i.e. high coverage) must continue so that elimination status is sustained.
Programmatic M&E: what monitoring tools need to be in place or revised?
Most national immunization programmes are already providing TTCV to pregnant women
through ANC contacts, and have an M&E system in place for this. However, as discussed in
Chapter 3, there may be a need to revise the ANC TTCV recording forms and monitoring
processes in order to improve accuracy, particularly for tallying pregnant women who are
already fully vaccinated with TTCV. Additionally, the ANC M&E system needs to monitor
and report the doses, coverage, and other relevant information (e.g. stock, AEFI, etc.) for
the TTCV administered through its services.
As additional child/adolescent TTVC boosters are added, the main recording and reporting
tools that are used by the immunization programme will need to be adapted or developed
to include the booster doses of TTCV vaccine. These are:
• vaccination register and defaulter tracking system
• tally sheet
• home-based record (vaccination card) defaulter tracking system
• stock record
• integrated monthly report.
Depending on the national schedule and delivery strategy for TTCV booster doses, and given
that the administration of these boosters spans several age groups over time, it will likely be
necessary to introduce several new monitoring tools and processes for the booster doses
given to older children/adolescents.
When there is a pre-existing vaccination contact with the same age group, such as MCV2 or
HPV vaccination, then the M&E tools can be adapted to include the TTCV booster. Likewise,
if TTCV booster vaccination includes a 4–7 year old target group, then this opportunity
(possibly at entry to day-care/crèche/school) can be used to check the vaccination status of
these children and catch up missed doses of other childhood vaccines (see Annex 9 for Job
Aid).
Good coordination and collaboration between national ANC and EPI programmes is
needed to obtain high-quality TTCV data (e.g. TTCV2+ and PAB coverage is correctly and
accurately calculated) so that the TTCV performance information from both programmes
can be shared and reviewed to inform any needed corrective actions.
68
Given the great diversity of approaches and country context, there are no generic M&E tools
or processes to recommend for TTCV. Each country will need to design its own system
according to its unique programme of service delivery. Those countries that have moved to
electronic monitoring systems will have clear advantages as it will be much easier to retain
and track the vaccinations given to individuals over the life course.
Helpful general information on immunization programme monitoring can be found in WHO

publication Immunization in Practice: A Practical Guide for Health Staff, Module 6 –
Monitoring and Surveillance (see Box 18) and also a forthcoming WHO resource Handbook
on the use, collection and improvement of immunization data (see Box 20).
How to periodically assess if MNTE status is sustained?
It is a proud moment when a country is officially How can we know that MNTE is
being sustained?
validated48 as having successfully achieved
• Periodically conduct a post-
elimination of maternal and neonatal tetanus.
validation assessment exercise.
This end to a major public health problem usually
and/or
represents years of hard work and investment,
• Check on MNTE as part of
and is accompanied by much national and
regular programme review
international media attention and celebration. opportunities.
Unfortunately, given the ubiquitous nature of Clostridium tetani in the environment, if high
coverage of vaccination with TTCV is not sustained, in the absence of high rates of clean
birth and cord care practices, it is possible that a country could lose its MNT elimination
status. For this reason, countries that have been validated need to periodically assess
whether MNTE is being sustained. If weaknesses or concerns are identified, corrective
actions must be planned and implemented swiftly.
A high-performing and reliable surveillance system for NT49 provides essential information
for MNTE monitoring and is the best method for monitoring programme success and
sustaining of MNTE status. However, as described in Chapter 5, vaccine preventable disease
48
WHO (2014). Validation of Maternal and Neonatal Tetanus Elimination (including a guide to the use of Lot
Quality Assurance – Cluster Sample Surveys to assess neonatal tetanus mortality). Geneva: World Health
Organization. For further information on the method of validating MNTE see
https://www.who.int/immunization/diseases/MNTE_initiative/en/index2.html.
49
Reliable NT surveillance: a) 0 cases notification functioning, b) completeness of district health facility
surveillance reporting ≥80%, c) annual review of hospital records at least once a year. The needs: 1. Case
definition of NT cases available and known in all health facilities, 2. Case investigation forms for suspected
cases available and cases investigated, 3. If rural district, functional community level surveillance.
69
surveillance systems are not always sufficiently robust and/or adequately funded in some
countries to be confidently relied upon.
As a consequence, countries that have validated elimination need to periodically conduct a

post-validation assessment of MNTE (a standalone exercise) or include checking on MNTE as
part of regular programme review opportunities (such as annual VPD data desk review, or
national immunization programme review). There may also be other periodic opportunities,
such as serosurveys (see Annex 10) or DHS/MICS/immunization coverage surveys, which can
provide information for monitoring MNTE. Nevertheless, surveys rarely provide precise
district-level coverage estimates and therefore, if MNTE status is to be reconfirmed as
validated, special surveys may need to be designed for selected districts.
Countries themselves, with support from partners/stakeholders, can decide which

approach(es) to use. The decision will depend on many factors such as overall performance
of the immunization programme, consideration of risk factors that might affect MNTE status
(e.g. emergencies, natural disasters, civil unrest/conflicts), available time and funding, and
the unique opportunities that arise.
Table 12 describes and outlines the pros and cons of various options that countries may
consider using to assess if MNTE is sustained after validation. It is possible that countries
may use a combination of approaches over time. Guidance for each of the options is
described in the following pages.
Table 12
Approaches to assessing if MNTE is sustained after validation
Approach Description PROs CONs

Compile and review
key MNTE indicators Conducted annually Possible tendency to
(fewer) as part of conduct in isolation (need
A. Annual VPD annual process of Integrated with to specifically invite other
data desk review immunization performance review MCH/ANC programmes to
programme VPD data of other vaccines join and share their data).
desk review.
No special funds Less focus on tetanus
If quality district needed alone (diluted)
coverage data,
especially PAB and Good quality data at
health facility district level is required
70
deliveries are More likely to for a valid assessment
available, this happen as being (and this may not be
approach can avoid established as norm available from low
having to do the more performing districts).
resource-intensive Linkage to cMYP and
post-validation annual planning
assessment.
MNTE sustainability
included as a part of Gives visibility to Frequency every 3-5 yrs
periodic national sustaining MNTE
immunization
programme review Partner involvement Availability of other
programmes to join
This would require Field visits
adapting the approach
outlined in C below, Funded High-quality data at
B. National and visiting the “at district level is required
immunization risk” districts as part Findings linked to for a valid assessment.
programme of the fieldwork. The action through
review questionnaires/data recommendations
collection variables and work-plan
used in Approach C
could be adapted and
imbedded into those
used for the
Immunization
Programme Review.
5-step method to Very rigorous Intensive

review core and
surrogate MNT risk Involves EPI, MCH Vertical approach (focus
indicators which and surveillance on MNTE only)
C. Post-validation requires planning, and programmes
assessment of depending on the size May be more costly
MNTE of a country, may Linked to action (outsourcing for
require 3-4 weeks preparation, workshop
preparation, a 3-day and implementation, if no
workshop, and field in-house expertise)
visits.
Irregular frequency
Serosurvey Accurate( if
correctly Usually implemented at
DHS/MICS surveys implemented) national level, rather than
D. Other
focus on districts at high
opportunities
Vaccination coverage Integrated risk for MNTE
surveys
Costly
71
May require specialized
external technical
expertise
Option A – Including MNTE sustainability in annual desk review of data

WHO and UNICEF encourage countries that have achieved MNTE to review their
surveillance and other relevant datasets annually, with the purpose to identify if any
districts are at risk of MNT re-emergence and if necessary, design and implement corrective
actions quickly. When undertaken jointly, this annual data review can serve to further
improve the synergy of EPI and MNCH programmes.
Beyond MNTE, for all programmes it is good management practice to carry out data desk
reviews regularly and at all administrative levels so that data problems can be identified and
addressed. The vision is that through the “use of data for action” all countries continuously
improve the performance of their national immunization programmes (see Box 20 for
guidance).
WHO recommends, that at a minimum, countries undertake an annual data review as an

initial step in compiling and critically analyzing the available information needed for an
annual programme performance review. A good time for such a review is after all annual
data are collated and before the WHO/UNICEF Joint Report Form is prepared and
submitted.
A desk review can be performed by immunization programme staff alone or it can be done
in collaboration with ANC and Health Management Information System (HMIS) staff. If
MNTE is to be included, a collaborative approach is the preferred option because it will
facilitate review of the non-immunization parameters, such as skilled birth delivery data.
Full datasets should be reviewed (i.e. full national dataset in the case of a national level
review).
In addition to vaccination coverage data, the desk review should include review of reported
NT surveillance by district. Silent districts should be identified. The desk review of data does
not require additional data collection. It is a review of existing data from routine
information systems and selected reproductive health data which focuses on the following
domains of data quality:
— completeness of administrative data;
— internal consistency of administrative data;
— external comparisons and consistency of administrative data (i.e. consistency
with survey estimates);
— consistency of population data estimates (i.e. target population, the
denominator for calculating coverage).
72
Normally, the desk review requires monthly or quarterly data by subnational administrative
area for the most recent reporting year, and annual aggregated data for the last three
reporting years, for the selected programmatic indicators.
Through analysis of the selected programme indicators, the desk review process quantifies
problems of data completeness, accuracy and consistency, and thus provides valuable
information on the adequacy of health-facility data to support planning and annual
monitoring.
Increasingly, donors (such as Gavi50) are making reviews of data and data quality along with
a data quality improvement plan, a requirement for countries to receive funding (see Box
19). With very little additional effort, these can also be used as opportunities to verify the
sustainability of MNTE.
Box 19
Gavi data quality requirements
Gavi requires that countries applying for all types of Gavi support:
1) Undertake routine monitoring of vaccination coverage data through an annual desk

review.
2) Conduct periodic (once every five years or more frequently where appropriate) in-
depth assessments of routine administrative vaccination coverage data.
3) Conduct periodic (at least once every five years) nationally representative vaccination
coverage surveys.
4) Use 1 and 2 to develop a data quality improvement plan, that it is ideally integrated
into other EPI plans.
WHO has developed a number of technical guides to support countries in the review of data
and data quality (Box 20).
Box 20
WHO key resources for data and data quality assessments/reviews
Handbook on the collection, assessment and use of immunization

data (to be published in 2019) – provides a framework for the
systematic assessment and strengthening of national and subnational
immunization data and information systems. This critical information
is intended for country decision-makers to improve and use
immunization and surveillance data, and enable them to:
1. decide what data are needed for programme improvement, and
use them for action;
50
Gavi. Support Guidelines. Geneva: Gavi the Vaccine Alliance (https://www.gavi.org/support/process/apply/,
accessed 15 January 2019).
73
2. develop efficient tools and information systems to collect those
data;
3. assess immunization data and systems, and implement data
quality improvement plans.
http://www.who.int/immunization/monitoring_surveillance/en/.
Data Quality Review (2017) – Module 2 of the Data Quality Review

(DQR) Toolkit. This toolkit is the result of collaboration between
WHO, The Global Fund, Gavi, and (USAID)/MEASURE Evaluation and
integrates and builds upon previous and current tools and methods
designed to assess data quality at facility level. It proposes a unified
approach to data quality, taking into account best practices and
lessons learned from many countries.
http://www.who.int/healthinfo/tools_data_analysis/dqr_modules/e
n/.
Option B – Integrating MNTE sustainability into a national immunization programme

review51
A national immunization programme review (also referred to as an EPI Review), is the
comprehensive assessment of the strengths and weaknesses of an immunization
programme at national, subnational and service-delivery levels. The purpose of this review
is to provide evidence for the programme’s strategic directions and priority activities.
With this in mind, an EPI review should be conducted before the immunization
programme’s strategic planning cycle, such as the cMYP. Review findings are presented
formally to the Ministry of Health, other relevant ministries, and often the country’s
Interagency Coordinating Committee (ICC) for their responses and endorsement for
incorporation into the next strategic plan.
Because EPI reviews are comprehensive and look at all aspects of the immunization
programme, it is only natural that they include the assessment of MNTE sustainability. WHO
recommends that EPI reviews should be conducted every 3–5 years. In 2017 WHO
published a new Guide for Conducting a National Immunization Programme Review (see Box
21).
51
Assessment of MNTE sustainability could also be incorporated into Reproductive Health Programme reviews
of ANC and skilled birth delivery, these reviews could assess the performance and missed opportunities for
TTCV vaccination of pregnant women at ANC contacts and clean delivery practices.
74
Periodic post-validation assessment of MNTE could also be included in a VPD surveillance
review as it is an exercise that may identify missed NT cases. Guidance on how to conduct a
VPD surveillance review is also provided in the Guide for Conducting a National
Immunization Programme Review (Box 21).
Box 21
WHO resource for conducting EPI reviews
A Guide for Conducting a National Immunization Programme Review

(2017) – provides guidance to individuals and teams responsible for
planning and implementing an EPI Review, with the main objectives to set
a benchmark for conducting quality EPI reviews, share best practices in
order to increase the efficiency and quality of reviews, including through
the integration of assessments as feasible, and to emphasize that EPI
reviews should be country-driven and part of a strategic planning
process.
http://www.who.int/immunization/documents/WHO_IVB_17.17/en/.
Option C – Conducting a post-validation assessment of MNTE

Annex 11 provides the full details on the methodology for conducting a stand-alone post-
validation assessment of MNTE. Use of MNTE risk assessment data sheet must be the
starting point for the post validation assessment. WHO website contains the MNTE risk
assessment data spreadsheet (Excel file format), sample tools, data tables and
questionnaires that can be adapted to the local context
(https://www.who.int/immunization/diseases/tetanus/en/).
A post-validation assessment comprises a desk-review of data to determine if MNTE

indicator standards are being maintained and to identify any districts that are potentially at
risk of not sustaining MNTE. It includes field visits and interviews at both the facility and
community level, which in the poorer performing districts (particularly if there is any doubt
about the quality of district level data), is critical to cross check the reported coverage of
TTCV, ANC and skilled birth delivery . The assessment includes bottleneck analysis and
development of a workplan and timeframe for implementing corrective actions, if needed.
The success of a post-validation assessment depends on good preparation and planning, as

well as well as the participation of other relevant programmes (particularly MNCH and ANC).
75
Option D – Using serosurveys52 to assess MNTE sustainability
In 2016, WHO Strategic Advisory Group of Experts

Glossary
(SAGE) on immunization recommended that
Serosurvey – the collection and testing
of blood specimens from a defined tetanus serosurveys be considered where feasible,
population over a specified period of to validate assessments of disease risk identified
time to determine antibodies against a using other data sources, and to guide vaccination
given etiologic agent as a direct
strategies. In 2018, WHO developed guidance for
measure of the population's immunity
tetanus serosurveys53 that references the
Seropositivity – serologic evidence of Guidelines on the use of Serosurveys in Support of
the presence of an antibody of a specific Measles and Rubella Elimination54 and the
type in the serum
updated WHO Vaccination Coverage Cluster
Seroprevalence – the proportion of Survey Reference Manual55.
people in a population who test positive
for serum antibodies against a specific Natural tetanus infection is not a source of
disease or pathogen; it is often immunity, so immunity presents an attractive
presented as a per cent of the total biomarker of vaccination coverage. Serosurveys
specimens tested
provide objective measures for estimating
Serosurveillance – serosurveys population immunity. Tetanus serosurveys can be
conducted routinely or periodically used by country programmes to provide an
immunologic assessment of true protection of
mothers and infants, and the correlation between maternal histories and their actual
protection. This may be useful for monitoring of disease risk and when assessing the
sustainability of MNTE. Routine serosurveillance programmes are however most common in
higher-income countries.
Use of tetanus serosurveys for monitoring achievement and maintenance of MNTE
MNTE is defined as a district level goal of <1 neonatal tetanus case per 1 000 live births in
every district per year. MNTE strategies include coverage with >80% of women with
52
Information on immunization coverage survey methods is available online at
http://www.who.int/immunization/monitoring_surveillance/routine/coverage/en/index2.html.
53
WHO (2018). Tetanus Serosurveys. Geneva: World Health Organization
(http://www.who.int/immunization/monitoring_surveillance/burden/vpd/WHO_SurveillanceVaccinePreventa
ble_25_Annex2_R1.pdf?ua=1, accessed 22 November 2018).
54
WHO (2019). Guidelines on the use of serosurveys in support of measles and rubella elimination. Geneva:
World Health Organization (insert link).
55
WHO (2018). Vaccination Coverage Cluster Survey: Reference Manual. Geneva: World Health Organization
(http://apps.who.int/iris/bitstream/handle/10665/272820/WHO-IVB-18.09-eng.pdf?ua=1, accessed 15
January 2019).
76
protective TTCV doses in every district. Conducting tetanus serosurveys in every district to
evaluate this indicator would be resource-intensive, and is not recommended.
However, serosurveys performed at the national level or in designated high-risk districts

that document >80% seroprotection can provide evidence compatible with elimination.
Nationally representative serosurveys may indicate the presence of important immunity
gaps, but may not confirm absence of immunity gaps in specific districts, required to
validate the sustainability of MNTE status.
Because tetanus is not eradicable and many countries have achieved MNTE through time-
limited campaigns, serosurveys should be considered where feasible to monitor
population immunity and MNT risk and guide vaccination strategies, especially in high-risk
districts.
Integrating the fieldwork with other surveys or laboratory testing efforts is recommended
where possible to allow monitoring of impact and sharing of costs across public health
programmes.
Before undertaking a tetanus serosurvey, programme-specific questions should be defined

so that specific objectives would drive the design of the serosurvey. Table 13 provides
possible objectives of serosurveys by target population.
Population-based cluster surveys are a method for obtaining estimates of seroprevalence

representative of the target population. During the planning and design stages, a protocol is
developed which defines preparation and implementation activities. More information on
survey design and sampling methodologies are available in Annex 10 and the WHO
Vaccination Coverage Cluster Survey Reference Manual56, while considerations for protocol
development, budgeting and implementation are included in the WHO Guidelines on the
Use of Serosurveys in Support of MR Elimination54.
Given the high cost of serosurveys, opportunities can be explored for integration with other
activities and cost savings. These can be generated by integrating tetanus serosurveys
implementation with other surveys such as Demographic Health Surveys (DHS), periodically
conducted in many countries. DHS often include blood sample collection for children and
WRA, and collect information on TTCV coverage, neonatal deaths, deliveries in health
facilities and by skilled health personnel, ANC visits, parity, obstetric care, health care
access, and socio-demographics that can inform interpretation of serosurvey results.
Table 13
Objectives of tetanus serosurveys by target population
56
(http://apps.who.int/iris/bitstream/handle/10665/272820/WHO-IVB-18.09-eng.pdf?ua=1, accessed 15
January 2019).
77
Target population Objectives of tetanus serosurveys
All ages and both sexes • Assess disparities in seroprotection (examples: adult males vs
females, young vs school-age children).
• Determine duration of immunity and need for booster dose
introduction or schedule optimization.
• Evaluate impact of catch-up vaccination or campaigns on
tetanus immunity (including TT-conjugate vaccines).
Children • Evaluate population immunity, compared with vaccination

coverage (ages 6–11 and 12–23 months).
(e.g. 6–23 months, 12–35 • Identify areas and subgroups needing targeted remediation
months, 6 months–5 (outreach, school-based immunization, etc.).
years, 1–15 years) • Determine duration of immunity and need for booster doses
(for example, at ages 12–23 months, 4–7 years, 9–15 years.)
Women of reproductive • Evaluate population immunity, compared with vaccination
age before achieving coverage (e.g.TTCV2+/PAB).
MNTE • Monitor impact of targeted campaigns in areas at high risk for
neonatal tetanus.
• Identify areas and subgroups needing targeted remediation
through campaigns, outreach or another strategy.
Women of reproductive • Monitor population immunity for maintenance of MNTE (e.g. in

age after achieving MNTE countries relying on campaigns to achieve MNTE).
• Provide evidence needed for TTCV booster dose introduction as
part of sustaining elimination.
• Identify areas and subgroups for targeted remediation such as
outreach vaccination or improved ANC and obstetric care.
AIDS Indicator Surveys (AIS) and Malaria Indicator Surveys (MIS) are other periodic surveys
that almost always include collection of blood samples. Serosurveys for vaccine-preventable
diseases (polio, measles, rubella, diphtheria, etc.) or other diseases (such as parasites,
arboviral, or food- and water-borne diseases) may also be options for integration in some
countries.
Another widely conducted periodic survey is the Multiple Indicator Cluster Survey (MICS),
but it less often includes collection of blood samples.
An additional potential opportunity for integration and cost savings is through the use of
multiplex laboratory testing such as bead-based immunofluorescence assays. Tetanus
multiplex assays have been demonstrated to have good performance and cost saving
compared to other laboratory tests. For more detail on options and cost see Annex 10.
Serosurvey findings should be interpreted in the context of current and historic data on
immunization programme policies and performance, including any past supplementary
immunization activities and disease incidence, if available. Tetanus survey results may differ
78
from administrative vaccination coverage or coverage survey estimates. For interpretation
of data, explanations of disparities between seroprotection rates and vaccinations coverage,
and use of results see Annex 10.
79
Annex 1. What is tetanus?
Clinical features
Tetanus is an acute infectious disease caused by tetanospasmin, a toxin produced by the spores of
bacterium Clostridium tetani (C. tetani) that grows in anaerobic conditions found in devitalized tissue
and decaying matter. Tetanus toxin disseminates to nervous tissue via the blood and lymphatic
system or enters the central nervous system along the peripheral motor neurons. The toxin blocks
inhibitory neurotransmitters of the central nervous system, resulting in muscular rigidity and
prolonged spasms.
Three clinical types of disease are often described.
1. Localized tetanus is uncommon and consists of spasms of muscles surrounding the site of
injury. Although generally mild, localized tetanus may progress to generalized form of
disease.
2. Cephalic tetanus is rare, associated with head or face lesions and/or with chronic ear
infections. It presents as cranial nerve palsies and may progress to generalized tetanus.
3. Generalized tetanus is most common (˃80% of cases) and presents as a generalized spastic
disease. The common first sign is muscular stiffness in the jaw (trismus or lockjaw), followed
by stiffness in the neck, difficulty in swallowing, rigidity of abdominal muscles, and spasms.
Typical features are the facial expression resembling a forced grin known as “risus
sardonicus”, and the position of backward arching of the head, neck and spine
(ophisthotonus). Generalized spasms are initially induced by sensory stimuli, but they occur
spontaneously as the disease progresses. During spasms the limbs are drawn up and flexed,
fists are tightly clenched, and toes are hyper-flexed. Intense spasms can lead to convulsive
fits. Ultimately, breathing becomes difficult as spasms become more frequent and
prolonged, leading to respiratory failure. Spasm of the glottis can result in immediate death.
Neonatal tetanus (NT) is a form of generalized tetanus occurring in newborn infants, most
often as a result of an infected umbilical cord stump. It is characterized by a newborn infant
who sucks and cries for the first few days after birth, but who subsequently develops
excessive crying and progressive difficulty to suck and breastfeed. Death occurs as a result of
paralysis of the respiratory muscles and/or inability to feed.
Depending on age, quality of care available, and the length of the incubation1 period, the case-
fatality rate of tetanus ranges from <1% for localized, 15–30% for cephalic, and 10–70% for
generalized, including neonatal, tetanus. Higher mortality rates are associated with shorter
incubation periods.
Tetanus can occur at any age and case-fatality rates are high. In the absence of medical
intervention, the case-fatality rate approaches 100%. Even with intensive care, case-fatality rates
are high (10–20%).
1
The incubation period of non-neonatal tetanus usually varies 3-21 days, although it may range from 1 day to
several months. The median interval to onset of symptoms is 7 days. In general, shorter incubation periods are
associated with more heavily contaminated wounds, more severe disease, and a worse prognosis. For
neonatal tetanus, the average incubation period is about 7 days, with a range from 3 to 14 days after birth in
90% of cases.
80
Reservoir and transmission
The spores of C. tetani are found everywhere in the environment, particularly in soil, ash, intestinal
tracts/faeces of animals and humans, and on the surfaces of skin and rusty tools like nails, needles,
barbed wire, farm implements, etc. Being very resistant to heat and most antiseptics, the spores can
survive for years.
Tetanus is not transmitted from person to person. Rather, C. tetani enters the human body through
contaminated wounds or tissue injuries, including those resulting from unclean deliveries, burns,
dental extractions and surgical procedures such as abortions and circumcision performed under
unhygienic conditions. Cases can occur in patients unable to recall a specific wound or injury and
may follow inapparent wounds or those considered trivial.
Neonatal tetanus usually occurs through introduction of tetanus spores via the umbilical cord during
the delivery through the use of an unclean instrument used to cut the cord or after delivery by
‘dressing’ the umbilical stump with substances contaminated with tetanus spores (see Chapter 4).
A person who recovers from tetanus does not develop immunity and must receive or complete a
tetanus vaccination series to prevent future disease.
Risk groups
Anyone who has not received a complete vaccination series against tetanus and who has greater
than usual risk of traumatic and puncture injury is at risk of contracting tetanus. This includes un- or
under-vaccinated women of reproductive age and their newborn delivered by untrained birth
attendant where delivery conditions and postpartum cord care practices are unclean.
Diagnosis
The diagnosis of tetanus is primarily based on clinical features, secondarily supported by
epidemiologic setting, and does not depend on laboratory confirmation. There are no reliable
confirmatory laboratory tests. WHO definitions for tetanus cases are summarized in the Table 11,
Chapter 5.
Clinical case management of neonatal tetanus

NT is a medical emergency requiring hospitalization, immediate treatment with human tetanus
immune globulin (TIG), agents to control muscle spasm (preferred choice benzodiazepines), and
antibiotics (preferred choice metronidazole or penicillin G). A single intramuscular dose of human
TIG is recommended as soon as possible to prevent further progression of the disease. If TIG is not
available, equine-derived antitoxin tetanus serum (ATS), can be given in a single intravenous dose,
after testing for hypersensitivity. Alternatively, intravenous immune globulin (IVIG) may be used.
Supportive care should be provided including keeping patients in a dark and quiet environment to
reduce the risk of reflex spasms, and nasogastric feeding for newborn infants. If muscle spasms are
occurring, it is critical to maintain a safe airway. If mechanical ventilation is not available, patients
should be carefully monitored in order to minimize spasm and autonomic dysfunction while avoiding
respiratory failure.
Clinical case management of non-neonatal tetanus

Non-NT is a medical emergency requiring hospitalization and immediate treatment with TIG, drugs
to control muscle spasm (preferred choice benzodiazepines), wound care, and antibiotics (preferred
81
choice metronidazole or penicillin G). A single intramuscular dose of human TIG is recommended as
soon as possible to prevent further progression of the disease. If TIG is not available, equine-derived
anti-tetanus serum (ATS) can be given in a single intravenous dose after testing for hypersensitivity.
Alternatively, intravenous immunoglobulin (IVIG) may be used.
Supportive care should be provided; patients should be kept in a dark and quiet environment to
reduce the risk of reflex spasms. If muscle spasms are occurring, it is critical to maintain a safe
airway. If mechanical ventilation is not available, patients should be carefully monitored in order to
minimize spasm and autonomic dysfunction while avoiding respiratory failure. Finally, before
discharge, age-appropriate tetanus toxoid containing vaccines (TTCV) should be administered to
prevent future disease.
Health burden of tetanus

The health burden of tetanus is almost completely preventable through immunization with TTCV
which are included in routine immunization programmes globally, and administered during
antenatal care contacts (ANC) in many countries.
In many countries tetanus disease surveillance is not well established and its incidence is not known
accurately. WHO estimates that in 2015, the latest year for which estimates are available,
approximately 34 000 newborns died from NT, which represents a 96% reduction from the situation
in the late 1980s. However, in 2017, a total of 12 476 tetanus cases including 2266 neonatal cases
were reported through the WHO/UNICEF Joint Reporting Form2 indicating the low reporting
sensitivity and uncertainty about the true disease incidence. However, WHO/UNICEF global and
regional summary data reflect the changing picture of tetanus with decreasing NT and persistent
burden of non-NT.
In settings where high TTCV coverage has not been achieved, immunity gaps exist. The immunity
gaps in women of reproductive age (WRA) and in their newborn infants who are not protected
against birth-associated tetanus contribute to continuing maternal and neonatal tetanus burden in
low-income countries. Immunity gaps have also been identified in school-aged children and
adolescents and notably adolescent/adult males in low income countries who did not receive
booster doses following the primary series given in infancy3, and who also need sustained protection
against tetanus following injuries and surgical procedures (e.g. motorbike accidents, voluntary male
circumcision as part of the programme for HIV/AIDS prevention, etc.). Because non-NT is beginning
to predominate globally, further reductions in disease incidence can be gained as countries are able
to ensure and maintain high coverage of the complete vaccination series (3 primary and 3 booster
doses prior to adolescence). Ultimately, the most equitable and sustainable approach is to ensure
tetanus protection over the life course for all members of the population.
2
WHO. Global and regional data and statistics [online database]. Geneva: World Health Organization
(http://www.who.int/immunization/monitoring_surveillance/data/regions/en/, accessed 15 January 2019).
3
82
Annex 2. Estimating target populations using UN Population Division
estimates and projections
Official United Nations population estimates and projections have been prepared by the UN
Population Division and are available in the series of Excel files that can be downloaded from the
following link: https://population.un.org/wpp/ . A new Revision is issued every two years and the
2017 Revision provides population projections for the period 2015-2100. The next Revision is due in
the first half of 2019.
To obtain the single age cohort estimates, do the following:
1. Open the UN Population Division home page (https://population.un.org/wpp/) and select

‘Download Data Files’.
2. Under Major topic/Special Groupings select ‘Interpolated indicators’ and the subgroup you are
interested in (e.g. Age composition, Annual Population by age, both sexes).
83
3. Download the Excel file and filter the year and the country you are looking for.
84
Annex 3. Determining the number of TTCV doses to be administered to a
pregnant woman at ANC contact or health facility – health worker training
scenarios
At a pregnant woman’s first contact with the health facility, health personnel enquire about her
previous vaccination history and examine her vaccination cards/records to determine the number of
Td doses required. A pregnant woman is deemed fully protected against tetanus upon receipt of 6
doses of a tetanus-containing vaccine, with the last dose being received in the adolescent period.
The following scenarios are used to determine the number of doses of tetanus-containing vaccines
to be administered to pregnant women when they visit the health facility.
If a pregnant woman visits the health facility for the first time and this is NOT her first pregnancy her
vaccination status must be reviewed against the schedule to ensure that she has been appropriately
vaccinated. Efforts are usually made by health workers to complete vaccination schedules post-
pregnancy.
85
Annex 4. How to implement the protection at birth (PAB) method in
practice?
Introduction of the PAB method may require a modification of vaccination cards/home-based records,
tally sheets, and immunization registers as well as an inclusion of this indicator in the HMIS at all levels,
along with quality training and supervision of workers at immunization sites for it to be successful.
Mothers need to bring their ANC or maternal immunization card to facilitate the process, otherwise
the health worker will have to rely on the mother’s recall to assess the number of TTCV doses received
in the past and their timing.
Materials required:
• revised child vaccination cards/home-based records with space to record PAB;
• revised immunization tally sheets that include a space for recording PAB status;
• revised immunization reporting forms adapted to include PAB totals;
• the PAB calculator (Figure 1), available from WHO, can facilitate the process for health
workers when they assess infants until they are confident with the method;
• availability/retention of long lasting immunization cards for mothers and children to prevent
the need to take and rely on mother’s recall of TTCV doses (which can be difficult given
other injections received by the mother during pregnancies or outside of pregnancies).
Method to assess PAB:

When mothers bring their children for their first vaccination1 of Penta/DTP1:
1) If the mother has a card

a. Ask to see it and check the number of Td doses given during the last pregnancy and
during previous pregnancies if indicated on the card (1 to 5 doses).
b. Note when the last Td dose was administered.
c. Tally PAB (birth protected against tetanus) if the mother has received:
• 2 properly spaced Td doses while pregnant with the child, OR
• 1 Td doses while pregnant with the child and 1 TT/Td doses at any time
before the pregnancy in the past, OR
• NO dose of Td while pregnant with the child BUT 3 or more doses at any
time during her reproductive years before that pregnancy.
• NO dose of Td while pregnant BUT 5 (if tetanus vaccination started during
adolescence or adulthood) or 6 TTCV doses previously which provides long-
term protection.
2) If mother does not have a card ask her questions about her Td immunization history:
a. How many doses of Td did she receive while pregnant with the child? If she received 2
doses, the birth was protected (PAB).
If she received one dose or no Td doses ask:
1
There are other contacts that can be used to assess PAB. Refer to Table 8 for implementation options.
86
b. Did she receive any doses of Td before this pregnancy? If yes, how many doses of Td did
she receive while not pregnant during Td/TT SIAs (special event when all women of
reproductive age, including pregnant and non-pregnant, received an injectable vaccine)?
c. Did she have previous pregnancies? If yes, ask her the number of Td/TT doses she
received during last 3 pregnancies.
Estimate if the infant was PAB based upon number of doses received and timing of last Td/TT doses
and tally accordingly (PAB or not PAB) using criteria listed above.
How to introduce the PAB method at district and health facility level
• Start implementing the PAB method in 1–2 districts or in health centres with high coverage ANC1
(over 80%) to understand and optimize the process of implementing this new method. Training,
vaccination cards/home-based records, recording and reporting forms are required.
• Prepare materials for training health staff to use the PAB method.
— Adapt vaccination cards/home-based records, tally sheets, recording and reporting
forms and make enough available for use during the training
— Distribute the list of questions to ask mothers to each trainee. Adapt question to local
context if needed.
• Prepare training agenda topics for each category of staff to be trained, district supervisors and
health facility staff.
• Make sure health facilities use the recommended 5-dose Td schedule for maternal vaccination.
• Conduct practical training for supervisors, vaccinators, and other health facility staff with hands-
on skills that are required, such as history taking, correctly assessing PAB, and correctly recording
on the tally sheet, etc.
• Make sure district supervisors master the method, and can effectively detect and correct mistakes.
• After 2–3 months compare administrative maternal Td coverage rates and the coverage assessed
by PAB method. Determine if you can extend the method nationally.
Example of reporting form for assessing protection at birth (adapted from Ghana reporting form)
87
Section A: Health facility information
1. Health Facility/District/Region:____________________________________________
2. Type of service:
a) Health facility (__)
b) Community outreach (__)
3. Date of visit _____________________
Section B: Mother information
1. Age of mother in years ______________
2. Gravida (total pregnancies so far) __________
3. Parity (total deliveries of number of children so far) _________
4. Have you ever received any TTCV vaccination (before or during last pregnancy)?
a) Yes (___)
b) No (___)
If No, skip to question 9.
5. If Yes in question 4, total number of TTCV vaccinations ____________
6. Source of information:
a) Maternal health record (___)
b) History/recall (___)
7. Did you receive TTCV vaccination in last pregnancy (this child)

a) Yes (___)
b) No (___)
If No, skip to question 9.
8. If Yes in question 7, what is the total number of TTCV vaccinations received? ___________
Decision point (use NT protection calculator if available)

Was the child protected from tetanus at birth?
Yes (___) No (___)
Decision rule:
If mother received 2 or more valid doses of TTCV – tick ‘yes’
If mother received less than 2 doses of TTCV – tick ‘no’
An easy to use tool for assessing PAB can be developed and used at the health facility, like the NT
protection calculator featured in Figure 1. It is used to assess PAB at the Penta1/DTP1 contact as
indicated in the instructions below.
Figure 1
NT protection calculator
88
Instructions for use of NT protection calculator:
Question 1: Ask the mother how many years ago she received her last dose of TTCV vaccine. Check
her vaccination card if available. Rotate the disk until it points to the indicated number of years. If
the answer is less than one year, assume one year.
Question 2: Ask the mother how many doses of TTCV vaccine she has received in her life. Check her
vaccination card if available. Look at the colour in the window corresponding to the number of doses
received.
Answer: If the colour in the window is green, the child was protected at birth by maternal
antibodies. If the colour in the window is red, the child was not protected by maternal antibodies at
birth, but may have been protected by clean birth practices. If the mother is eligible for TTCV
vaccination, vaccinate her.
Annex 5. Example of national tally sheet for TTCV2+ (or Td2+) for pregnant
women
89
Proper recording of TTCV2+ coverage in pregnant women is important for NT prevention and should
be emphasized to health workers. When assessing vaccination status, health workers must check
whether a pregnant woman was fully vaccinated prior to pregnancy and vaccinate her if needed.
Such monitoring of TTCV vaccination status prevents the unnecessary vaccinations of pregnant
women. The example below is a national aggregate tally sheet for TTCV2+vaccination coverage in
pregnant women, and can be adapted to the specific country context.
Fully %TTCV2+
Inadequately Fully vaccinated for this vaccinated coverage
vaccinated
Total
pregnancy prior to the for
Region/ TTCV2+
Target pregnancy pregnant
District g=b+c+
b c d e women =
a d+e+f
(1st dose)
(2nd (3rd (4th (5th f g/target x
dose) dose) dose) dose) 100
Region/
District 1
Region/
District 2
Region/
District 3
Region/
District 4
Region/
District 5
Region/
District 6
Region/
District 7
Region/
District 8
Region/
District 9
Region/
District 10
Region/
District 11
Region/
District 12
Region/
District 13
Private
Sector
Total
Annex 6. Five moments for hand hygiene
90
Hand hygiene is the primary measure to reduce infections. Cleaning hands at the right times and in
the right way makes most health care-associated infections preventable. In 2009, WHO developed
guidelines for hand hygiene in health care which provides a thorough review of the evidence on
hand hygiene in health care and specific recommendations to improve practices and reduce
transmission of pathogenic microorganisms to patients and health care workers. These guidelines
are complemented with a guide for implementation and an implementation toolkit which contain
many ready-to-use and field-tested practical tools (see http://www.who.int/gpsc/5may/tools/en/).
The approach ‘My 5 Moments of Hand Hygiene’ explains five situations when cleaning the hands
properly is recommended.
WHEN?
1 Clean your hands before touching a patient when
BEFORE TOUCHING A approaching him/her.
PATIENT WHY?
To protect the patient against harmful germs carried on your
hands.
WHEN?
2 Clean your hands immediately before performing a
BEFORE CLEAN/ASEPTIC clean/aseptic procedure.
PROCEDURE WHY?
To protect the patient against harmful germs, including the
patient’s own, from entering his/her body.
WHEN?
3 Clean your hands immediately after an exposure risk to body
AFTER BODY FLUID fluids (and after glove removal).
EXPOSURE RISK WHY?
To protect yourself and the health-care environment from
harmful patient germs.
WHEN?
4 Clean your hands after touching a patient and her/his
AFTER TOUCHING A immediate surroundings, when leaving the patient’s side.
PATIENT WHY?
WHEN?
5 Clean your hands after touching any object or furniture in the
AFTER TOUCHING patient’s immediate surroundings, when leaving – even if the
PATIENT patient has not been touched.
SURROUNDINGS WHY?
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Annex 7. WHO Recommended Surveillance Standards for Neonatal Tetanus
(NT)1
Effective NT surveillance is a key component of the MNTE strategy.
Rationale and objectives of surveillance

Every NT case is an event that marks the failure of multiple levels of the health system. The key
objective of NT surveillance is to detect cases of NT towards monitoring achievement and
maintenance of MNTE, defined as less than one NT case per 1 000 live births annually in every
district. NT surveillance data (or a lack thereof) are used to identify areas and subpopulations at
high-risk for NT and guide effective public health response for MNTE. High-quality surveillance data
and other key programme indicators should be used at the national and subnational (district) levels
to monitor the impact of interventions and achievement and maintenance of MNTE.
Type of surveillance recommended

The minimal recommended standard for NT surveillance is nationwide, case-based surveillance,
meaning that every suspected NT case should be investigated and classified as confirmed or
discarded. NT surveillance is population-based and includes all neonates aged 0–28 days. Laboratory
confirmation is not an aspect of NT surveillance, as the basis of tetanus diagnosis is clinical rather
than laboratory-based.
Case detection
• Facility-based. Conduct facility-based surveillance by sensitizing surveillance focal points and
key clinical staff (such as paediatric ward and special care nursery staff) at designated
reporting sites to immediately report every suspected NT case to the designated surveillance
staff. The network of reporting sites should include both public and private facilities.
• Passive surveillance. Report the number of suspected NT cases seen at designated reporting
sites at a specified frequency (weekly or monthly) to the next higher level, even if there are
zero cases (referred to as “zero reporting”). Health facility reports should be regularly
monitored and verified by surveillance staff.
• Active surveillance. Make regular visits to reporting sites that are most likely to admit NT
patients (weekly at major health facilities), or as part of active search for acute flaccid
paralysis (AFP) and measles-rubella. During visits, review facility registers for unreported NT
cases and ask key clinical staff whether any new NT case has been identified since the
previous visit. At a minimum, every facility should review registers for NT cases annually.
Active surveillance can also be conducted in the community during outreach visits, SIAs or
case investigations.
• Community-based surveillance. Community-based surveillance should be done in high-risk
areas through a network of traditional birth attendants, community leaders, traditional
healers or other community members that are sensitized to report suspected NT cases and
1
Excerpt from Neonatal tetanus surveillance standards (2018) available at:
http://www.who.int/immunization/monitoring_surveillance/burden/vpd/WHO_SurveillanceVaccinePreventab
le_14_NeonatalTetanus_R1.pdf?ua=1.
92
deaths to health authorities. In these cases, lay case definitions may be used in order to
ensure that all suspected NT cases and deaths are detected and reported.
Linkages to other surveillance

Ideally, NT surveillance is linked with active surveillance for AFP and measles-rubella and routine
aggregate surveillance for zero reporting as part of the Integrated Disease Surveillance and Response
(IDSR). Linkage to vital events surveillance and neonatal death surveillance may be useful for
increasing NT surveillance sensitivity and helping to conserve resources.
Case definitions and final classification

All suspected NT cases should be investigated. The basis for case classification is entirely clinical and
does not depend on laboratory confirmation.
Suspected NT case
A case that meets either of the following two criteria:

• any neonate who could suck and cry normally during the first two days of life and
developed tetanus-like illness or death between 3 and 28 days of age;
OR
• any neonate who died of an unknown cause during the first month of life.
Final case classification

Confirmed Discarded Not investigated
Any suspected NT case found

to have all three of the The suspected NT case that Any suspected NT case not
following: has been investigated and investigated or without
- normal ability to suck and cry does not satisfy the clinical information available on age
during the first two days of criteria for confirmation or has and symptoms to confirm the
life; an alternate diagnosis. case.
AND
- could not suck normally
between 3 and 28 days of age;
AND
- developed muscle stiffness
and/or spasms (jerking).
Case investigation
• Ideally, every NT case should be investigated. However, before achieving MNTE, the emphasis
should be on implementing SIAs and community interventions to reduce NT burden in known
high-risk areas.
• Once MNTE has been achieved, each suspected NT case or death should be investigated by
trained staff to confirm or discard the case, ideally within seven days of notification. The sooner
the mother and persons who attended the birth are visited, the more likely they are to be
available and remember relevant details.
• All reported cases or deaths should be investigated using a standard case investigation form to
confirm the NT diagnosis based on case history and symptoms. The investigation should
93
determine why the infant contracted tetanus, such as lack of maternal vaccination, birth
unattended or attended by unskilled staff, use of unhygienic cutting tools or application of
substances to the umbilical stump. A simplified algorithm can be used to determine if the
mother and infant were protected at birth (PAB) against tetanus, based on maternal vaccination
history (see Box 1 below).
• As NT diagnosis is entirely clinical, misdiagnosis can occur due to lack of training or lack of
exposure to NT cases in low-incidence settings. Misdiagnosed cases of NT are most commonly
meningitis, sepsis (including umbilical sepsis) or birth defects. Trismus (lockjaw) is absent in
these illnesses. In addition, there is no bulging of the fontanelle in NT. During tetanus spasms,
the child is conscious, and the spasm is often brought on by stimuli such as light and sound,
unlike other convulsions from other causes such as high fever where the child is unconscious. In
addition to clinical presentation, details from the case investigation (such as lack of maternal
vaccination, unskilled birth attendant or application of unhygienic substances to the cord) may
support the NT diagnosis.
Ensure that the filled case investigation form details the findings and actions taken or
recommended, and is sent to the next level. Also give written feedback to the reporting facility and
community.
Box 1
Simplified protection at birth (PAB) method
During case investigations, surveillance staff can use a simplified PAB method to determine
whether a birth is protected against tetanus based on written maternal immunization records
and questioning the mother about the number TTCV doses she received during the last
pregnancy and the number of doses she received during school-age, previous pregnancies, or
campaigns/outreach occurring any time before the last pregnancy. A birth is protected if the
mother received:
• two TTCV doses while pregnant with the last child (with second dose delivered at least
two weeks before birth);
OR
• one TTCV dose while pregnant with the last child (delivered at least two weeks before
birth) and one or more doses at any time before that pregnancy;
OR
• no dose while pregnant with the last child and three or more adolescent/adult doses at
any time before that pregnancy.
Public health response

• The mother of the suspected NT case and any other unprotected woman of reproductive age in
the community should receive TTCV as indicated (two doses separated by four weeks) to protect
her and infants during future births. If possible, the mother should be provided a TTCV dose
94
before leaving the hospital, as part of outreach vaccination organized in conjunction with case
investigation, or within six months of confirming the NT case.
• Identification of a confirmed NT case may indicate a more systematic problem. A rapid
community assessment should be conducted to determine the need for interventions.
— Starting from the house where the confirmed NT case occurred, move house to house to
interview 10–15 other mothers of the community who delivered in the last two years
about their vaccination status, delivery place and attendant, application of substances to
the umbilical cord, and the survival and vaccination status of their last born child.
— If at least 80% of mothers are protected (either through clean birth, including delivery by
a skilled birth attendant and hygienic cord practices, or PAB status), the response can be
limited to vaccination of the mother of the NT case and promotion of hygienic cord care
practices.
— If less than 80% of mothers are protected, determine the cause of non-protection and
formulate an appropriate intervention. If less than 80% of mothers are protected
through vaccination, assure that this community is added to the microplan for routine
vaccination sessions, including outreach sessions that should include vaccination of
pregnant women with TTCV. Make a return visit with a basket of interventions, including
providing TTCV to pregnant women.
— If less than 90% of last-born children received DTP3, strengthen routine immunization
services in the area (e.g. incorporate community in outreach microplans, reduce missed
opportunities at outreach sessions, ensure vaccination at antenatal care visits and sick
child visits).
— Complete corrective actions based on the factors that placed the infant at risk for NT.
Corrective actions may include maternal vaccination, education on correct delivery or
cord care practices and better coordination with maternal and child health services.
Specimen collection
No specimens are collected for NT cases, as there is no laboratory diagnosis of NT.
Laboratory
Tetanus diagnosis is entirely based on clinical features and does not depend on laboratory
confirmation. C. tetani is recovered from microbiologic culture of wounds in only about 30% of
cases, and the organism is sometimes isolated from patients who do not have tetanus. As non-
toxigenic strains of C. tetani also exist, definitive laboratory diagnosis is not currently possible.
Data collection, reporting and use

Recommended data elements
(* designated core variable required to be completed as part of an adequate case investigation)
• Case notification
— Name (if confidentiality is a concern the name can be omitted so long as a unique
identifier exists)*
— Unique case identifier
— Date of notification*
— Source of notification (health facility location, name of person)
— Date of case investigation*
95
• Geographic information
— Place of residence (city, district, and province)
— Reporting health facility
• Demographics
— Date of birth*
— Sex*
• Clinical
— Age of baby in days at onset of symptoms
— Date of onset (date of onset of lockjaw/inability to suck)*
— Date of hospitalization
— Signs and symptoms, including at minimum:
▪ Ability to suck and cry during the first 2 days of life*
▪ Between 3 and 28 days of age, cannot suck normally*
▪ Muscle stiffness and/or spasms (jerking)*
• Neonatal outcome
— Final outcome of child’s illness: alive, dead, unknown*
— Final classification: confirmed, discarded, not investigated, unknown
— Date of discharge/death
• Maternal and perinatal risk factors
— Age of mother
— Ethnic group
— Migrant status (mother’s length of residency in locality where delivery took place)
— Number of live births delivered (including this most recent one) by the mother
— Number of previous births with similar symptoms and whether child(ren) survived
— Number of antenatal care (ANC) contacts the mother had with a trained healthcare
worker during this last pregnancy
— Location of ANC (for follow-up regarding missed vaccination opportunity)
— PAB status of last birth (see Box 1)*
— Place of birth: hospital, health centre, home, other, or unknown*
— Assistance during childbirth: health staff (skilled birth attendant), traditional birth
attendant, family member/alone, other, or unknown*
▪ If not health staff, ask if clean surface and hands were used for delivery
— Tool(s) used to cut umbilical cord and sterilization of tool (cleaned and boiled)*
— Substance put on umbilical cord*
— Maternal outcome (dead, alive; cause of death)
• Public health response
— Mother given TTCV (such as Td) dose(s) at the time of case detection/investigation, or as
soon as possible afterwards (yes, no, not needed/already protected,
unknown/unavailable)
▪ If given protective dose, record date that TTCV dose was given
Reporting recommendations and requirements

The number of NT cases should be reported separately from non-NT cases by designated reporting
sites weekly, monthly or at another specified frequency, even if there are zero cases (zero
96
reporting). Copies of case investigation forms or electronic data from these forms should be
forwarded to the national level.
Cases of NT (0–28 days of age) should be reported annually to WHO-UNICEF, and separately from
non-NT (˃28 days of age), through the WHO/UNICEF Joint Reporting Form available online at
http://www.who.int/immunization/monitoring_surveillance/routine/reporting/en/. Reporting of NT
is not required by International Health Regulations (IHR).
Recommended data analyses

• Number and incidence of confirmed NT cases per 1 000 live births, by month, year, sex, and
district
• Percentage of confirmed NT cases that were PAB by maternal vaccination (see Box 1)
• Percentage of confirmed NT cases whose mother received ANC, and among those who
received ANC, those not vaccinated (for analysis of missed opportunities)
• Percentage distribution of confirmed NT cases by
— Place of birth (health facility or home delivery)
— Type of birth assistance
— Type of cord-cutting tools used
— Type of umbilical cord dressing used
— Mother’s age
— Mother’s parity (first birth vs. multiple births)
• Distribution of outcomes (death, left against medical advice, survived, unknown) among
confirmed NT cases
• Percentage of confirmed NT cases whose mother received a TTCV dose(s) after the NT case
occurred, as a result of the case detection/investigation or soon after
• Percentage of neonatal deaths attributable to NT (if part of neonatal death surveillance)
• Risk assessments (see section Using data for decision-making below)
As with other diseases, surveillance data should be triangulated with data from the immunization
programme, such as vaccination coverage, history of SIAs, ANC coverage, and skilled birth
attendance (SBA) coverage to understand the entire picture of the disease when formulating
conclusions and new policies or strategies.
Using data for decision-making

• Monitor achievement and maintenance of MNTE (<1 NT case per 1 000 live births in every
district) and document evidence towards validation and /or sustainability of elimination.
• Input data such as NT rates, TT protection, ANC and SBA coverage into annual risk assessments
to identify high-risk geographical areas for targeting improvements in antenatal, obstetric, and
vaccination services and conducting targeted SIAs for women of reproductive age.
• Identify with results of case investigations NT risk factors such as place/type of delivery, cord
care, age and parity of mother, migrant status and ethnicity, in order to design appropriate
messaging and interventions.
• Monitor impact of interventions, including SIAs.
• Identify missed opportunities for maternal immunization with TTCV, such as ANC visits, child
visits and outreach vaccination sites.
97
• Document evidence needed for immunization policy or strategy change (for example,
introduction of WHO-recommended booster doses and school-based immunization if first-time
mothers are not being reached with vaccination at ANC visits).
• Rapidly identify cases for appropriate case management (refer NT cases for medical care and
provide TTCV dose to mother).
• Monitor surveillance performance indicators and identify areas that need targeted surveillance
reviews or strengthening (this may be needed when surveillance data appears unreliable when
compared with NT risk).
Surveillance performance indicators

• Evaluate NT surveillance through periodic national reviews approximately every five years,
integrating with other VPDs and including triangulation of aggregate and case-based NT
reports as well as a review of facility records for missed cases.
• Conduct retrospective review of facility registers in hospitals and large health clinics
at least annually to identify previously unreported NT cases alongside other VPDs and other
diseases.
• As part of the quarterly EPI data review meetings, review surveillance, coverage, and
programme performance data at national and subnational level to help identify potential
areas where surveillance gaps might exist or surveillance needs to be strengthened.
• At least annually, review the indicators listed in Table 1.
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Table 1
Neonatal tetanus surveillance performance indicators
Surveillance Description Target Formula Notes
indicator
Completeness of Percentage of designated sites ≥90% # sites reporting NT/#
reporting reporting NT data, even in the designated reporting sites for
absence of cases (zero reporting) NT surveillance x 100 (for
given time period)
Timeliness of Percentage of designated sites ≥80% # of surveillance units in the At each level reports should be
reporting reporting NT data on time, even in country reporting by the received on or before the
the absence of cases (zero deadline/# of designated requested date.
reporting) reporting sites for NT
surveillance x 100
Completeness of Proportion of neonatal tetanus ≥90% # of NT case investigations/# If case-based database only
investigation suspected cases that have been of suspected NT cases includes data on case investigations
investigated (only among cases reported x 100 performed, this indicator can be
reported from health facilities) calculated as: # suspected cases in
the case-based dataset/# suspected
cases in the aggregate report x 100
This indicator will reflect the
representativeness of case-based
surveillance and efficiency of case
investigations.
Timeliness of Percentage of all suspected cases ≥80% # suspected NT cases
investigation investigated within 7 days of investigated within 7 days of
notification notification/# suspected NT
cases investigated x 100
Adequacy of Percentage of investigated ≥80% # of suspected NT cases for 1) The core variables are: case
investigation suspect cases with complete which an adequate identification, date of birth, sex,
information for all core variables investigation was completed place of usual residence, date of
with collection of 12 core illness onset, date of notification,
variables/# of suspected NT date of investigation, symptoms in
cases investigated x 100 case definition, outcome
(alive/dead), maternal vaccination
history, place/type of delivery, tool
99
for cutting cord, and material
applied to cord.
2) For any case, if information on

any of the core variables is missing,
the investigation will be considered
inadequate.
Achievement and Percentage of districts with <1 NT 100% # districts with <1 NT case per Ideally, this indicator should be
maintenance of case per 1 000 live births 1,000 live births/total # calculated using confirmed NT
MNTE districts x 100 cases. If the completeness of
investigating suspect cases is <90%,
the indicator can be calculated
using suspect cases to highlight
districts needing targeted
interventions and programme
strengthening.
Adequate case Percentage of confirmed NT cases 100% # of mothers of NT cases that
response for which the mother received a received a TTCV dose in
TTCV dose in conjunction with conjunction with case
case detection or investigation detection or
investigation/total # of NT case
investigations x 100
100
Contact tracing and management
As tetanus is not contagious, no contact tracing is needed.
Surveillance, investigation and response during outbreaks

Tetanus is not considered an outbreak-prone disease. In general, NT outbreaks do not occur, but
clusters linked to a single source of substandard clinical care have been observed. For disease
clusters occurring in countries where MNTE has already been achieved, every case should still be
investigated and there should be no change in the surveillance process. Before achieving MNTE,
disease clusters should be investigated to determine risk factors, but the primary emphasis should be
on implementing SIAs in known high-risk areas to reduce NT burden.
Special considerations in surveillance of neonatal tetanus

• Risk assessments. NT risk assessments are used to identify high-risk areas for targeted SIAs,
programme improvement, and field evaluation during MNTE validation. For countries yet to
achieve MNTE, NT risk assessments should be performed at least every one to three years,
triangulating district-level data on NT cases and rates, skilled birth attendance (SBA), TT/PAB
coverage from routine and SIAs, and other proxy indicators. For countries that have already
achieved MNTE, regular risk assessments using the same inputs should be done (Annex 11).
• Ethical and equity issues. Discussion of neonatal deaths may be a sensitive topic, especially
among some cultures and ethnic groups. NT may occur most frequently among marginalized
groups missed by the immunization programme, such as migrants, the homeless and residents in
urban slums, who may be sensitive to questioning by outside government officials. Use guidance
from local health staff on how best to address these challenges.
• Neonatal death surveys. The relative contribution of NT to neonatal mortality can be assessed
through audits of neonatal deaths at health facilities or in community settings, as described in
the document called Making every baby count: audit and review of stillbirths and neonatal
deaths1 and implemented in some countries as part of the Every Newborn Action Plan. In some
countries, activities in sentinel communities may approach or achieve real-time reporting of
neonatal deaths and attempts should be made to link NT case detection to investigation through
case-based surveillance. Of note, neonatal mortality cluster surveys (with verbal autopsies) are
also conducted in the districts determined to be of highest risk for NT during MNTE validation
exercises2.
• Serological surveys or serosurveillance. Where feasible, serosurveys of tetanus IgG among adult
women should be considered as a complementary tool for monitoring MNT risk and guiding
vaccination strategies. Because immunity does not result from natural infection, tetanus
seroprotection reflects population immunity from vaccination. Close attention should be paid to
the survey objective, sampling strategies and laboratory methods to ensure that results are valid
and interpretable. Serosurveillance should not replace NT surveillance.
1
WHO (2016). Making every baby count: audit and review of stillbirths and neonatal deaths. Geneva: World
Health Organization (http://apps.who.int/iris/bitstream/10665/249523/1/9789241511223-eng.pdf?ua=1,
2
WHO, UNICEF. Pre-validation assessment guidelines [for maternal and neonatal tetanus elimination]. Geneva:
World Health Organization; 2013 draft. Available upon request from the World Health Organization.
101
Annex 8. WHO Recommended Surveillance Standards for Non-NT1
Rationale and objectives of surveillance

The need for improved tetanus surveillance is underscored by the absence of reliable global
estimates of non-NT cases and deaths, including maternal tetanus (see Box 1). A key objective of
surveillance for non-NT is to monitor disease burden and changing epidemiology over time in order
to assess the impact of vaccination and to identify gaps in the immunization programme. This
information should be used to inform targeted strengthening of routine immunization services and
optimize strategies and immunization schedules, including introduction and timing of booster doses.
Another key objective is detecting and investigating unusual disease clusters. Finally, rapid detection
of cases can help save lives and allow for proper treatment, including antitoxin, to begin.
Box 1
Maternal tetanus
Maternal tetanus is defined as tetanus occurring during pregnancy or within 6 weeks after
pregnancy ends (with birth, miscarriage or abortion) and has the same risk factors and means of
prevention as neonatal tetanus. For this reason, NT elimination (<1 case per 1 000 live births) is
considered a proxy for maternal tetanus elimination.
If country programmes decide that maternal tetanus is of special priority, reports of maternal
tetanus could be handled similar to reports of neonatal tetanus, including case investigation, rapid
community assessments and public health response (see Annex 7). When feasible, serosurveys of
tetanus immunity among women of reproductive age can be a complementary tool for monitoring
MNT risk and guiding vaccination strategies (see Annex 10).
Type of surveillance recommended

The minimal recommended standard for non-NT surveillance is nationwide, aggregate surveillance
with routine reporting from inpatient facilities and investigation of any unusual disease clusters. Non-
NT surveillance is population-based and includes all persons ≥28 days of age. Laboratory
confirmation is not an aspect of non-NT surveillance, as the basis of tetanus diagnosis is clinical
rather than laboratory-based.
Enhanced surveillance for non-NT consists of case-based surveillance to aid understanding the
epidemiology of the disease and causes of infection and to allow monitoring of treatment practices
and disease outcomes. Either nationwide or sentinel surveillance would be advised, depending on
the burden of disease, health-seeking behaviours and resources available in the country (sentinel
surveillance requires fewer resources).
Case detection
• Establish a formal surveillance network of inpatient facilities designated for non-NT reporting
and sensitize surveillance focal points and key clinical staff (such as ICU staff) to recognize
and report non-NT cases per national guidelines.
1
Excerpt from Non-neonatal tetanus surveillance standards (2018) available at:
http://www.who.int/immunization/monitoring_surveillance/burden/vpd/WHO_SurveillanceVaccinePreventabl
e_15_Non_neoTetanus_R1.pdf?ua=1.
102
• Report the aggregate number of inpatients with a final diagnosis of non-NT at designated
reporting sites at a specified frequency (weekly or monthly), even if there are zero cases
(referred to as zero reporting). Health facility reports should be regularly monitored and
verified by surveillance staff. Unusually high numbers reported in a given month may
represent a data entry error that needs to be corrected, or a disease cluster that needs
investigation.
• For countries deciding to establish case-based surveillance for non-NT, public and private
referral hospitals with intensive care capacity located in areas with high non-NT burden
should be prioritized as sentinel sites to capture the majority of non-NT cases. Later,
surveillance can be expanded to include additional sites that represent a larger extent of the
population.
Linkages to other surveillance

Ideally, non-NT surveillance is linked with aggregate surveillance systems for other diseases through
systems such as IDSR and EWARN. In some cases, HMIS reporting may be used for facility-based
aggregate reporting of non-NT cases. Linkage to maternal death surveillance and response (MDSR)
and other maternal child health post-partum surveillance systems may be relevant in some
countries.
Case definitions and final classification

Suspected non-NT case
Any person >28 days of age with acute onset of at least one of the following:
- trismus (lockjaw)
- risus sardonicus (sustained spasm of the facial muscles)
- generalized muscle spasms (contractions).
Final case classification

Confirmed Probable Discarded
A suspected non-NT case A suspected non-NT case A case that has been
clinically confirmed as tetanus without clinical confirmation investigated and does not
by a physician/trained by a physician/trained satisfy the clinical criteria for
clinician. clinician. confirmation or has an
alternate diagnosis.
Note: The basis for case classification is entirely clinical and does not depend on laboratory confirmation. In
low incidence settings, many clinicians may have never seen a tetanus case, making clinical diagnosis more
challenging. During tetanus spasms, the patient is usually conscious, and the spasm is often brought on by
stimuli such as light and sound, unlike other convulsions where the patient may be unconscious. Although
tetanus diagnosis usually includes a history of injury or wound, tetanus may also occur in patients who are
unable to recall a specific wound or injury. The most common differential diagnoses for tetanus are
hypocalcemic tetany, drug-induced dystonias (from drugs such as phenothiazines), meningoencephalitis,
strychnine poisoning, and trismus due to dental infections.
103
Case investigation
In countries conducting aggregate surveillance, information should be collected at designated health
facilities from inpatient records for cases with a final diagnosis of non-NT, and reported to the next
higher level based on national surveillance guidelines. No further investigation is needed except in
the case of unusual disease clusters.
In countries conducting case-based surveillance, each suspected tetanus case should be investigated
using a standard case investigation form, ideally within seven days of notification, to confirm the
diagnosis and determine the cause of infection. Send filled case investigation forms detailing findings
and actions taken or recommended to the next level and give written feedback to the reporting
facility and community.
Tetanus immunoglobulin (TIG) or antitoxin tetanus serum (ATS) should be given immediately, even if
investigation cannot be performed in a timely manner.
Specimen collection
No specimens are collected for non-NT cases, as there is no laboratory diagnosis.
Laboratory
Same as for NT, non-NT diagnosis is entirely based on clinical features and does not depend on
laboratory confirmation.
Data collection, reporting and use

Recommended data elements
Aggregate surveillance
• Age group (optimal for tetanus epidemiology are 29 days–4 years, 5–14, 15–44, 45–64 and
65+ years, but can be aligned with needs of integrated surveillance system)
• Sex
• Month
• Geographical area
• Immunization status (if possible)
Case-based surveillance
• Case notification
— Name (if confidentiality is a concern the name can be omitted so long as unique
identifier exists.
— Unique case identifier (such as EPID number)
— Date of notification
— Source of notification (health facility location, name of person)
— Date of case investigation
• Demographics
— Sex
— Date of birth (or age if date of birth not available)
— Race/ethnicity (if relevant)
— Migrant status
— Educational status
— Place of residence (city, district, province)
104
• Clinical
— Date of onset
— Date of hospitalizations
— Signs and symptoms (at a minimum)
▪ Trismus
▪ Risus sardonicus
▪ Muscle spasms
• Vaccination status
— Number of tetanus vaccine doses (preferably by documentation, by recall if
documentation not available)
— Date of vaccine doses, especially the last dose
— Receipt of tetanus conjugate vaccines (such as Hib, MenA, MenC, Pneumo, Typhoid,
depending on formulation)
• Risk factors
— Occupation
— History of wound or injury (including chigger/jigger infestation and intravenous drug
use)
— History of surgery or medical procedure (e.g. male circumcision)
— History of dental or ear infection
— Maternal tetanus
▪ Current or recent pregnancies (within the last 6 weeks)
• Number of antenatal care (ANC) contacts during pregnancy
• Pregnancy outcome (live birth/healthy child, live birth/NT case, still
birth, miscarriage, or abortion)
• Information on birth/pregnancy termination (date, location, who
attended, clean surface/hands/tools)
▪ Parity
— Application of unhygienic substances to wounds
• Treatment
— Tetanus immunoglobulin (TIG), antitoxin tetanus serum (ATS), intravenous immune
globulin (IVIG) given
▪ Date of administration
— Antibiotics given (type)
▪ Date of administration (starting date)
• Outcome
— Outcome (patient survived, died, unknown)
— Final classification (confirmed, probable, discarded)
— Date of discharge/death
Reporting recommendations and requirements

The number of non-NT cases should be reported separately from NT cases by designated reporting
sites weekly, monthly or at another specified frequency, even if there are zero cases (zero reporting).
Case investigation forms or electronic data from these forms should be forwarded to the national
level.
105
For the purpose of case counts, tally only confirmed inpatient cases for national reporting because
non-NT is managed on an inpatient basis. Including outpatients would likely result in overestimation
because of problems like misdiagnosis, reporting errors from smaller facilities or double-counting of
outpatients referred for inpatient admission.
Cases of non-NT should be reported annually to WHO-UNICEF and separately from NT, through the
JRF (http://www.who.int/immunization/monitoring_surveillance/routine/reporting/en/). Reporting
of NT is not required by International Health Regulations (IHR).
Recommended data analyses are:

• number of non-NT cases and incidence rates by month, year and geographical area
• incidence rates by sex and age group (29 days–4 years, 5–14, 15–44, 45–64, and 65+ years)
• trends in the sex ratio of non-NT cases over time
• proportion of cases protected against tetanus (see Table 1)
• proportion of cases by risk factor
• proportion of cases receiving TIG/ATS/IVIG
• case-fatality ratio (number of non-NT deaths / number of non-NT cases x 100)
• proportion of maternal tetanus cases.
As with other diseases, surveillance data should be triangulated with data from the immunization
programme, such as coverage and historic vaccination schedules, to understand the entire picture of
the disease when formulating conclusions and new policy.
Table 1
Expected duration of protection provided by valid tetanus toxoid containing vaccine (TTCV) doses – a
valid dose is defined as a dose administered after the minimum time interval required. TTCV doses
received by adolescents and adults during childhood are only included if verified by reviewing written
records such as infant or school vaccination records.
Cumulative no. of
TTCV doses if Cumulative no. of TTCV Minimum interval Duration of protection
vaccination began in doses if vaccination begun between doses to be from receipt of last
infancy ≥1 year of age considered valid dose
TTCV1 TTCV1 — None
TTCV2/TTCV3 TTCV2 4 weeks 3 years
TTCV4 TTCV3 6 months 5 years
TTCV5 TTCV4 1 year 10 years
TTCV6 TTCV5 1 year 20–30 years
Using data for decision making

• Monitor disease burden and impact of vaccination, including TTCV campaigns targeting women
of reproductive age or wide-age range campaigns for both sexes with TT-conjugate vaccines such
as MenA.
106
• Identify and investigate non-NT disease clusters to determine risk factors and appropriately
design risk mitigation strategies such as provision of vaccine and improved hygiene practices.
• Identify gaps in the immunization programme (areas with low coverage, cold chain issues
resulting in frozen TTCV, etc.) to inform targeted strengthening of routine immunization services
or need for catch-up vaccination.
• Identify groups at higher risk for tetanus infection (women of reproductive age, school-age
children, male adults, elderly) to inform changes in policy or strategy such as introduction of
booster doses or optimization of schedule.
• Monitor maternal tetanus to strengthen MNTE strategies and reduce missed opportunities for
vaccination such as ANC, sick visits and outreach.
• Periodically assess tetanus risk factors (occupation, road accidents, unclean deliveries/surgeries,
migrant status, ethnicity) to appropriately design and implement messaging and interventions.
• Rapidly identify cases for appropriate case management, including provision of TIG/ATS/IVIG.
• Monitor surveillance reporting to identify areas that need targeted surveillance reviews or
strengthening, where surveillance data appear unreliable.
Surveillance performance indicators

Evaluate non-NT surveillance through periodic national reviews approximately every five years,
integrating with other VPDs and including triangulation of aggregate and case-based NT reports as
well as a review of facility records for missed cases. Targeted subnational reviews and data quality
assessments can be conducted more frequently. As part of the quarterly EPI data review meetings,
review surveillance, coverage and programme performance data at national and subnational level to
help identify potential areas where surveillance gaps might exist or surveillance needs to be
strengthened. Regular monitoring of surveillance indicators could help identify specific areas of the
surveillance system and reporting network that should be targeted for improvement (Table 2).
Contact tracing and management

As tetanus is not contagious, no contact tracing is needed.
Surveillance, investigation and response in outbreak settings

Definition of outbreak
For non-NT, traditional communicable disease outbreaks do not occur because there is no person-to-
person transmission, but cases may cluster together in time and space as a result of the same
environmental exposure. A specific threshold has not been defined for the number of non-NT cases
that should trigger investigation, but any substantial increase compared with previous reporting from
the same area within a comparable timeframe should be investigated. A cluster of non-NT cases
could include those occurring within the same geographic and time proximity, or multiple cases
determined to be linked to the same source or event. Clusters of non-NT cases have been
documented after natural disasters (earthquakes, tsunamis, typhoons), after male circumcision and
from injection drug use.
Changes to surveillance in an outbreak setting

Even in countries with aggregate surveillance, data should be regularly monitored to identify
potential clusters of non-NT disease. Clusters should be followed up with investigation to determine
if there is a common cause. If a cluster is identified, consider line listing of cases with a limited set of
107
variables so that more detailed analysis of cases can be performed (by age, sex, vaccination status,
risk factors, treatment, etc.). This information can be used to inform risk mitigation efforts, including
provision of vaccine and promotion of improved hygiene practices, both for individuals and for
healthcare settings.
Special aspects of investigation

If there is a non-NT cluster, it is important to identify environmental exposure risk factors
(nosocomial, occupational, accident).
Table 2
Performance indicators for non-NT surveillance
Surveillance Indicator Target How to calculate Comments
attribute (numerator/denominator)
Completeness Percentage of ≥90% # designated sites reporting Designated reporting
of reporting designated non-NT/# designated sites for non-NT
reporting sites reporting sites for non-NT surveillance might
reporting non- surveillance x 100 (for given only include hospitals
NT data, even in time period) or referral hospitals,
the absence of rather than all health
cases facilities.
Timeliness of Percentage of ≥80% # designated sites reporting At each level reports
reporting designated sites non-NT on time/# designated should be received on
reporting non-NT reporting sites for non-NT or before the
data on time surveillance x 100 requested date.
Completeness Percentage of ≥90% # of non-NT case If case-based
of case suspected non- investigations/# of suspected database only
investigation NT cases that non-NT cases reported x 100 includes data on case
(case-based have been investigations
surveillance investigated, performed, this
only) only among indicator can be
cases reported calculated as: #
from health suspected cases in
facilities the case-based
included in case- dataset/# suspected
based cases in the
surveillance aggregate report x
100
This indicator will

reflect the
representativeness of
case-based
surveillance and
efficiency of case
investigations.
Timeliness of Percentage of all ≥80% # suspected non-NT cases
case suspected non- investigated within 7 days of
investigation NT cases notification/# suspected non-
investigated NT cases investigated x 100
108
(case-based within 7 days of
surveillance notification
only)
Special considerations in surveillance for non-neonatal tetanus

• Serological surveys or serosurveillance. Serological assessments of tetanus IgG antibody levels in
a survey setting may be useful for evaluating protection against tetanus. Because immunity does
not result from natural infection, tetanus seroprotection reflects population immunity from
vaccination. However, the role of serological investigations should always be complementary to
surveillance and other assessment methods, and the survey objective and outcomes should be
well defined (see Annex 10).
• Immunity gaps resulting from lack of booster doses. Investigations have documented immunity
gaps and higher burden of disease in school-aged children and adult men in countries not
providing the WHO-recommended six TTCV doses to both sexes. All immunization programmes
should review programme data and adjust routine immunization schedules to ensure tetanus
protection over the life course (three primary doses in infancy and three booster doses in
childhood/adolescence)2.
• Humanitarian emergencies. Non-NT should be considered for inclusion in surveillance systems
set up during humanitarian emergencies because of the documented outbreaks after
earthquakes and tsunamis3.
2
Dalal S, Samuelson J, et al. (2016). Tetanus disease and deaths in men reveal need for vaccination. Bulletin of
the World Health Organization. 94:613–21 (http://www.who.int/bulletin/volumes/94/8/15-166777/en/,
3
WHO (2017). Vaccination in acute humanitarian emergencies: a framework for decision making. Geneva:
World Health Organization (http://apps.who.int/iris/bitstream/10665/255575/1/WHO-IVB-17.03-eng.pdf,
109
Annex 9. Illustrative example of job aid on screening for vaccine eligibility
Example from Establishing and strengthening immunization in the second year of life guidance,
available online at http://apps.who.int/iris/bitstream/handle/10665/260556/9789241513678-
eng.pdf?ua=1 , adapted from Timor Leste and based on their vaccination schedule (up to 2 years of
age). This example can be adapted to match local vaccination schedules.
110
111
Annex 10. Serosurveys1
Background and rationale

Tetanus is not eradicable because tetanus spores persist in the environment. Continued high and
uniform vaccination coverage is needed to protect the population. Tetanus immunity from infant
vaccination wanes with age, so booster doses are given at optimal ages to provide continuous
protection across the lifespan (at 12–23 months, 4–7 years, and 9–15 years). In countries where
childhood booster doses are not provided and maternal and neonatal tetanus is a public health
problem, five TTCV doses (preferably tetanus-diphtheria vaccine, or Td) are provided to women of
reproductive age (WRA) through campaigns in high-risk areas and pregnant women through routine
services. In some countries, the provision of tetanus-toxoid conjugate vaccines (such as Hib,
meningococcal, pneumococcal and typhoid conjugate vaccines) may boost tetanus immunity, but
these vaccines are not counted towards the TTCV doses required in the schedule.
Coverage with three doses of diphtheria, tetanus and pertussis containing vaccine (TTCV3) is a key
performance indicator of the routine immunization system. However, countries may encounter
challenges with monitoring TTCV3 coverage through administrative methods due to inaccurate
recording and reporting of vaccination doses and outdated target populations, significant migration
from rural areas or through surveys with limited documentation of vaccination history or other
biases associated with the survey methods (see Figure 1).
Countries that have yet to introduce the recommended three TTCV booster doses beyond infancy
may desire evidence to make the decision for introduction. Some countries have achieved or will
achieve MNTE through TTCV campaigns without accompanying health systems improvements such
as routine immunization, antenatal care (ANC) or obstetric care. Continued monitoring is needed to
ensure that MNTE is sustained. Even in countries that include six TTCV doses in their vaccination
schedules, evidence may be needed to optimize schedules and close immunity gaps.
Figure 1
Tetanus vaccination coverage and seroprotection among children 12–23 months in linked coverage
and serosurveys in three districts in Ethiopia, 20132
1
Excerpt from Tetanus Serosurveys (2018) available online at:
http://www.who.int/immunization/monitoring_surveillance/burden/vpd/WHO_SurveillanceVaccinePreventabl
e_25_Annex2_R1.pdf?ua=1.
2
Travassos MA, et al. (2016). Immunization coverage surveys and linked biomarker serosurveys in three
regions in Ethiopia. PLoS One. 11(3):e0149970 (https://doi.org/10.1371/journal.pone.0149970, accessed 15
January 2019).
112
In general, serosurveys provide objective biological measures for estimating population immunity
and monitoring disease risk. Data from serosurveys are increasingly desired to guide policy and
strategy, from supporting vaccine introduction to verifying disease elimination. Periodic cross-
sectional serosurveys, or serosurveillance, can help document challenges with suboptimal
programme implementation and changes in epidemiology resulting from accelerated disease control
efforts. Routine serosurveillance programmes are most common in higher-income settings, such as
Australia, the Netherlands and UK, but a case has been made for greater use of serological data for
vaccination decision-making in lower and middle-income settings.
A limitation of serosurveys is that they cannot discriminate the number of vaccine doses received (for
example, two or three doses) or the source of the immunizing event (natural infection for most
diseases, routine vaccination or campaign vaccination). Unlike other vaccine-preventable diseases, a
natural tetanus infection is not a source of immunity for tetanus, so immunity is an attractive
biomarker of vaccination coverage.
Tetanus serosurveys are helpful in assessing population immunity resulting from cumulative
coverage from vaccine doses, vaccine effectiveness (for example, reduced effectiveness due to
freezing TTCV) and waning immunity over time (see Figure 2). Assessment of tetanus vaccination
history for older children and adults is particularly challenging due to missing documentation,
inability to recall infant doses and other doses received, and doses from sources not recorded on
cards (such as during campaigns or after injury). In fact, tetanus serosurveys among adult women
have shown vaccination coverage to be underestimated compared with tetanus seroprotection (see
Table 1).
As immunization programmes mature and increasing proportions of adult women receive protective
TTCV doses during infancy, school, campaigns and other places outside antenatal care, the disparity
between seroprotection and maternal vaccination coverage is expected to grow. Indicators for
maternal vaccination coverage include a second or subsequent TTCV dose (TTCV2+) or protected at
113
birth (PAB)3. As part of broader tetanus prevention efforts, the Strategic Advisory Group of Experts
(SAGE)4 on Immunization recommended that, where feasible, tetanus serosurveys should be
considered to validate assessments of disease risk identified by other data sources, and to guide
vaccination strategies, especially in high-risk districts.
Figure 2
Tetanus seroprotection among individuals at district level in Kenya, Tanzania and Mozambique5
Seroprotection was defined as ≥0.01 IU/ml by a tetanus bead-based immunofluorescence assay.

Immunity gaps in older children and adult males exist because of waning immunity and provision of
booster doses only to women of reproductive age. Of the three countries, only Mozambique
provides two TTCV boosters to both sexes in first and second grades.
Table 1
3
Protection at birth (PAB) is a supplementary method of determining tetanus vaccination coverage, particularly
where TT2+ is unreliable. PAB can be routinely monitored by surveying maternal vaccination status during
infant DTPCV1 visits, and can also be assessed during vaccination coverage surveys that ask about maternal
vaccination status during the last pregnancy occurring with a specified time period (1, 2, or 5 prior years). PAB
is defined as having received 2 TTCV doses during the last pregnancy, ≥2 total TTCV doses with the last dose ≤3
years prior to the last birth, ≥3 doses with the last dose ≤5 years prior, ≥4 doses with the last dose ≤ 10 years
prior, or ≥5 prior doses. A simplified PAB definition has also been proposed as mothers who received: (i) 2 TTCV
doses while pregnant with the last child (with second dose delivered at least 2 weeks before birth), or (ii) 1
TTCV dose while pregnant with the last child (delivered at least 2 weeks before birth) and 1 or more doses at
any time before that pregnancy, or (iii) no dose while pregnant with the last child and 3 or more
adolescent/adult doses at any time before that pregnancy.
4
WHO (2016). Meeting of the Strategic Advisory Group of Experts on immunization, October 2016 –
conclusions and recommendations. Weekly Epidemiological Record. 90: 561–584
(http://apps.who.int/iris/bitstream/handle/10665/251810/WER9148.pdf?sequence=1, accessed 15 January
2019).
5
Scobie HM, et al. (2017). Tetanus immunity gaps in children 5-14 years and men ≥15 years of age revealed by
integrated disease serosurveillance in Kenya, Tanzania, and Mozambique. The American Journal of Tropical
Medicine and Hygiene. 96(2):415-20 (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5303047/, accessed 15
January 2019).
114
Summary of vaccination coverage and seroprotection results of nationally representative tetanus
serosurveys among reproductive-age women
Survey Population PAB coverage Seroprotection
Burundi, 1989 Women giving birth in 73% 67%*

past year
Central African Republic, Women giving birth in 76% 89%**
1996 past year
Cambodia, 2012 Women aged 15–39 — 88%**

years
Parous women aged 15– 83% 97%**
39 years
PAB = protected at birth
* ≥ 0.01 IU/ml in competition ELISA
** ≥ 0.01 IU/ml in Double Antigen ELISA
Survey setting and population

Globally, surveillance for neonatal and non-neonatal tetanus has been documented to be
suboptimal. Serosurveillance complements disease surveillance but does not replace it. Tetanus
serologic data can provide helpful information for monitoring population immunity and disease risk.
It should be considered, where feasible, to guide vaccination strategies. Tetanus serosurveys can be
useful in settings where reported vaccination coverage is high or where vaccination coverage data is
known to be unreliable and independent verification of population immunity is desired. However,
serosurveys are resource-intensive and not recommended for every country.
Across a broad age range, tetanus serological data can be used to assess immunity gaps and inform
evidence-based remediation (catch-up vaccination or campaigns, optimization of schedules or
addition of booster doses, etc.). In children, tetanus immunity has been identified as a potential
biomarker for monitoring TTCV coverage. In WRA, sufficient tetanus immunity can be used to help
monitor achievement and maintenance of MNTE (see Box 1 below). Depending on the country, WRA
may be defined as 15–39 years, 15–45 years, 15–49 years or another similar age range. Women
giving birth in the last year, two years or five years may be specifically targeted in order to assess
recent changes in maternal vaccination programme performance. Restricting the survey population
to include individuals targeted for vaccination within the last one to two years may improve recall of
vaccination doses received and comparability between vaccination coverage and seroprotection.
However, the number of household visits required to identify an eligible survey cohort with a narrow
age range or birth period (such as one year) will be larger than the number of households required
for a wider age range or birth period (such as five years). This has important resource implications.
Box 1
Use of tetanus serosurveys for monitoring achievement and maintenance of MNTE
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MNTE is defined as a district level goal of <1 neonatal tetanus case per 1 000 live births in every
district per year. MNTE strategies include coverage with >80% of women with protective TTCV
doses in every district. Conducting tetanus serosurveys in every district to evaluate this indicator
would be resource-intensive, and is not recommended. However, serosurveys performed at the
national level or in designated high-risk districts that document >80% seroprotection can provide
evidence compatible with elimination.
Because tetanus is not eradicable and many countries have achieved MNTE through time-limited
campaigns, serosurveys should be considered where feasible to monitor population immunity and
MNT risk and guide vaccination strategies, especially in high-risk districts. Integration of fieldwork
for surveys or laboratory testing is recommended where possible to allow monitoring of impact
and sharing of costs across public health programmes.
Objectives of tetanus serosurveys

Serosurveys assess population immunity rather than directly assessing vaccination coverage. For
tetanus, the proportion of the population with demonstrated seroprotection is related to vaccination
coverage as well as vaccine effectiveness and duration of vaccine-induced immunity. Before
undertaking a tetanus serosurvey, it is important to define the questions the programme hopes to
answer and how the data will be used to guide policy, strategy or programme improvement. The
specific objectives should drive the design of a tetanus serosurvey (see Table 2).
Usually, nationally representative estimates of seroprotection are desired, but subnational estimates
in high-risk areas may suffice depending on the objective and the country situation. Inclusion of age,
sex or regional/subnational strata in national surveys allows greater insight into variation in
seroprotection, but can greatly increase the cost of the survey. Surveys of residual sera from ANC
clinics or other convenience surveys are the most economical option, but the results of these surveys
are not generalizable to the rest of the population and are subject to selection bias. For example,
ANC coverage is low in many countries and those attending ANC are more likely to receive tetanus
vaccination.
Table 2
Objectives of tetanus serosurveys by target population
All ages and both sexes

• Assess disparities in seroprotection (examples: adult males vs females, young vs school-
age children)
• Determine duration of immunity and need for booster dose introduction or schedule
optimization
• Evaluate impact of catch-up vaccination or campaigns on tetanus immunity (including TT-
conjugate vaccines)
Children (e.g. 6–23 months, 12–35 months, 6 months–5 years, 1–15 years)
• Evaluate population immunity, compared with vaccination coverage (ages 6–11 and 12–23
months)
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• Identify areas and subgroups needing targeted remediation (outreach, school-based
immunization, etc.)
• Determine duration of immunity and need for booster doses (for example, at ages 12–23
months, 4–7 years, 9–15 years)
Women of reproductive age before achieving MNTE
• Evaluate population immunity, compared with vaccination coverage (for example,
TTCV2+/PAB)
• Monitor impact of targeted campaigns in areas at high risk for neonatal tetanus
• Identify areas and subgroups needing targeted remediation through campaigns, outreach
or another strategy
Women of reproductive age after achieving MNTE
• Monitor population immunity for maintenance of MNTE (for example, in countries relying
on campaigns to achieve MNTE)
• Provide evidence needed for TTCV booster dose introduction as part of sustaining
elimination
• Identify areas and subgroups for targeted remediation such as outreach vaccination or
improved ANC and obstetric care
Survey methods
Population-based cluster surveys are a method for obtaining estimates of seroprevalence that are
representative of the target population. General considerations for protocol development, budgeting
and implementation of serosurveys are included in the WHO Guidelines on the Use of Serosurveys in
Support of Measles and Rubella (MR) Elimination (2018)6, while details on cluster survey design and
sampling methodologies are found in the WHO Vaccination Coverage Cluster Survey Reference
Manual7. Close attention should be paid to survey sampling and laboratory methods to ensure that
results are valid and interpretable.
During survey implementation, provide adequate training, supervision, and monitoring to ensure
that survey staff follow the established protocol for selection of survey participants. Consent should
be collected from all survey participants and parents of selected children; assent may also be needed
for older children. The most important variables to collect for detailed analysis of seroprotection
across subpopulations are age, sex, area of residence, education and vaccination status. For WRA, it
is also important to collect data on parity, ANC attendance, clean birth and cord care for the last
pregnancy.
Care should be taken to document the history of all received TTCV doses on home-based and health
facility records, and by recall of doses received. TTCV doses may be documented on infant/child,
school, maternal and campaign vaccination cards. Questions for recall of vaccination history should
6
WHO. Guidelines on the use of serosurveys in support of measles and rubella elimination. Geneva: World
Health Organization (insert link).
7
(http://apps.who.int/iris/bitstream/handle/10665/272820/WHO-IVB-18.09-eng.pdf?ua=1, accessed 15 January
2019).
117
prompt survey participants about receipt of vaccines from all relevant sources (clinic/outreach,
school, military, campaigns, etc.), and such questions should be asked of every participant in case the
recorded history is incomplete. In settings where TT-conjugate vaccines are given (such as
MenAfrivac campaigns), those doses should also be recorded separately (see sample questionnaire).
Sample collection
Serum or dried bloodspots (DBS) are the specimens of choice for serosurveys. Serum specimens
prepared from whole blood (5 mL for older children and adults, 2.5 mL for infants and young
children) are used most widely in serosurveys. DBS prepared from fingerprick blood may be more
acceptable for participants and have the advantage of not requiring immediate cold storage and cold
shipment. However, drying DBS completely may be challenging in humid climates, and the additional
step required to elute serum from filter papers increases the labour required in the laboratory. Oral
fluid specimens have been used for research, but are not recommended for regular use in tetanus
serosurveys. Protocols for specimen preparation and storage are summarized elsewhere6.
Serologic testing of tetanus immunity

The accepted minimum level of IgG antibody required for protection against tetanus is 0.01 IU/mL, as
measured by the in vivo neutralization assay (gold standard). However, the antibody level required to
achieve absolute protection against tetanus disease has been shown to vary based on individual
exposure, including anatomical site and severity of infection. In vitro tests currently validated as
accurate at the threshold for seroprotection (≥0.01 IU/mL) include modified ELISAs, such as
competition ELISA, double-antigen ELISA (DAE), and toxin-binding inhibition (ToBI), as well as bead-
based immunofluorescence assays such as multiplex bead assay (MBA). Though not commercially
available, DAE, ToBI and MBA have all been successfully established in developing country settings
and used in large serosurveys. Before serosurvey use, newly established tetanus assays should be
validated against a reference test and calibrated with the tetanus international reference serum
(TE-3).
A number of commercial options exist for tetanus indirect ELISAs, making these tests the most
commonly used. However, indirect ELISAs have issues with non-specific binding in the low
seroprotective range (≥0.01–0.20 IU/mL) requiring a higher cut-off; antitoxin concentrations of ≥0.1–
0.2 IU/mL are usually defined as seroprotective when indirect ELISA is used (ideally determined by
validation against reference test). None of the commercial indirect ELISAs have been validated
against in vivo or in vitro tests accurate at the 0.01 IU/mL threshold for seroprotection. In addition to
concerns of misclassification bias related to using a higher cut-off for indirect ELISA, documented
variation in the sensitivity and accuracy of individual tests leads to important disparities in final
results. For these reasons, use of indirect ELISAs is not generally recommended for tetanus
serosurveys without confirmatory testing of samples with ELISA results <0.2 IU/ml by in vivo
neutralization, DAE, ToBI or bead-based assays. Point of care tetanus IgG testing is also not
recommended for serosurveys.
Opportunities for integration and cost savings

The largest cost savings for tetanus serosurveys can be generated by integrating field
implementation with other planned vaccination coverage or serosurveys. Demographic Health
Surveys (DHS) are periodically conducted in many countries and often include blood sample for
children and WRA, in addition to collecting information on TTCV coverage, neonatal deaths,
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deliveries in health facilities and by skilled birth attendants, ANC visits, parity, obstetric care, health
care access and socio-demographics that can inform interpretation of serosurvey results. The
Multiple Indicator Cluster Survey (MICS) is also a widely conducted periodic survey, but less often
includes collection of blood samples. AIDS Indicator Surveys (AIS) and Malaria Indicator Surveys (MIS)
are other periodic surveys that almost always include collection of blood samples. Serosurveys for
vaccine-preventable diseases (polio, measles, rubella, diphtheria, etc.) or other diseases (such as
parasites, arboviral or food- and water-borne diseases) may also be options for integration in some
countries.
Another potential opportunity for integration and cost savings is through multiplex laboratory
testing. Bead-based immunofluorescence assays can be multiplexed to measure antibodies to
multiple viral, parasitic or bacterial antigens simultaneously from the same small volume of serum
(1–5 µL, or <1/10 of the volume required for ELISA). Tetanus multiplex assays have been
demonstrated to have good performance with a relative cost savings over other laboratory tests. In
one serosurvey, the cost of adding tetanus to a multiplex assay with 19 other antigens was 0.30 USD
per sample, and the total cost of the 20-plex assay was less than the reference tetanus test (DAE) at
30 USD per sample. In costing of other serosurveys, the marginal cost of a 20-plex bead assay
performed in-country is less than 20 USD per sample — similar in cost to separate ELISAs for measles
and rubella.
Suggested data analyses

During data analysis, survey methods should be used to account for cluster survey design elements
including strata, cluster and survey weights. Survey methods should also be used to calculate point
estimates and 95% confidence intervals for the overall target population and survey strata. When
estimating within subpopulations not included in the original survey design (for example, those with
three or more documented doses), the analyst should first evaluate whether the available sample
size for each subpopulation is adequate, and whether the subsample is spread across many clusters
or is from only a few clusters representing a narrow segment of the overall sample. The analyst
should also consider the impact of the survey weights if the subsample is small. The following data
analyses and visualizations are suggested if sufficient data is available:
• Proportion of target population with tetanus seroprotection (binary outcome using defined
antibody level threshold, ≥0.01 for modified ELISAs, and bead-based immunoassays)
— When reporting tetanus IgG results, the test method and cut-off used should be
stated, as well as the correlation with a neutralization assay or other validation
process, if known.
• Proportion of tetanus seroprotection by vaccination status (number of doses received) and
data source (card, recall or card + recall).
• Proportion of tetanus seroprotection by subpopulation, such as age, geographic area, parity
or education.
• Statistical comparisons of differences in seroprotection across subpopulations, noting that
sample size may be insufficient to detect true differences among subpopulations.
• Median antibody levels by vaccination status and subpopulation.
• Proportion by antibody level category (0.01–0.09 IU/mL, 0.1–0.9 IU/mL, ≥1.0 IU/mL, with
higher antibody levels generally correlating with higher probability and duration of tetanus
protection).
119
— It is unnecessary and technically inaccurate to give a qualitative assignment of
duration of protection such as “short” or “long”. Instead, report the numeric
category ranges.
• For parous women unprotected by vaccination, proportion with clean birth with skilled
health personnel and clean cord care for last birth.
• Suggested data visualization:
— stacked bar chart of proportions of antibody level categories by subpopulation
(Figure 3);
— if geographic strata are included, a choropleth map of seroprotection by subnational
area;
— for wide age range surveys, bar chart of proportion seroprotected (primary y-axis)
and line chart of median antibody level (secondary y-axis) by age cohort (x-axis)
(Figure 3).
Figure 3
Tetanus antibody levels by age group in national serosurvey of the Dutch population, 20068
Tetanus antibody levels were assessed using a tetanus bead-based immunofluorescence where
seroprotection was defined as ≥0.01 IU/ml. The proportions of individuals by age groups and
antibody level categories (<0.01 IU/ml, 0.01-0.09 IU/ml, 0.1-0.9 IU/ml, ≥1.0 IU/ml) are depicted with
stacked bars and the geometric mean concentrations as a black line with 95% confidence intervals.
Higher antibody levels generally correlate with higher probability and duration of tetanus protection
8
Steens A, et al. (2010). High tetanus antitoxin antibody concentrations in the Netherlands: a
seroepidemiological study. Vaccine. 28(49):7803-9. doi: 10.1016/j.vaccine.2010.09.036.
120
and are noted following tetanus vaccination opportunities (depicted above the graph). The “MenC
mass campaign” was a meningococcal C tetanus-toxoid conjugate catch-up vaccination campaign
that occurred in 2002 as part of vaccine introduction into the routine immunization program at 14
months of age.
Interpretation of results
Tetanus antibody levels generally correlate with the robustness and duration of immunological
protection against tetanus resulting from vaccination. Serosurvey findings should be interpreted in
light of current and historic data on immunization programme policies and performance (schedules,
coverage, etc.), including any past supplementary immunization activities and disease incidence, if
available. This approach will give context to serosurvey results and may help highlight areas for
potential improvement.
Limitations of the serosurvey should be included in any presentation of results, including selection
bias (exclusion or non-random selection of participants), information bias (systematic bias from
misclassification error of test or vaccination history) and non-response bias. Considerations for the
use of serologic data to assess vaccination history have been summarized elsewhere9. It is important
to recognize that serological data are not necessarily a gold standard for assessing vaccination status,
and that serosurveys performed using tests with poor accuracy (inability to correctly classify
seroprotection) have a substantial limitation.
Tetanus serosurvey results may differ from reported vaccination coverage or coverage survey
estimates (Figure 1), and have the potential to indicate that immunization services are more or less
effective than previously appreciated. Possible explanations for these differences are summarized in
Table 3. Administrative TTCV2+ coverage of pregnant women is known to underestimate true
protection against tetanus, as it excludes women unvaccinated during their current pregnancy but
already protected through previous vaccination, or who received one dose in pregnancy and had
undocumented previous doses. PAB coverage can also be underestimated due to residual immunity
from infant doses in some women, or from booster doses provided outside routine services and
misclassification of PAB status due to poor availability of documented vaccination history and recall
bias.
Table 3
Possible explanations for differences in tetanus seroprotection and vaccination coverage
Result Possible explanations
Tetanus • inaccuracies in reported TTCV coverage data (numerator and/or

seroprotection denominator)
higher than • immunity from TTCV doses not documented/recalled (examples:
vaccination infant/childhood doses for adult participants, TTCV and MenAfriVac
coverage campaigns doses, doses following injury)
9
MacNeil A, Lee CW, Dietz V (2014). Issues and considerations in the use of serologic biomarkers for classifying
vaccination history in household surveys. Vaccine. 32(39):4893–900. doi: 10.1016/j.vaccine.2014.07.005.
121
• partial series of multidose vaccine (such as TTCV2) results in immunity
• suboptimal specificity of laboratory testing, especially in areas with low
immunity
Tetanus • inaccuracies in reported TTCV coverage data (numerator and/or
seroprotection denominator)
lower than • reduced vaccine effectiveness from substandard vaccine administration or
vaccination freezing of TTCV
• age-group affected by waning tetanus immunity
coverage
• suboptimal sensitivity of laboratory testing, especially in areas with high
immunity
Use of results
Results from tetanus serosurveys have important potential use for monitoring population immunity
and disease risk, as well as guiding policy, strategy and targeted improvements for the immunization
programme. Triangulation of serosurvey results with current and historic immunization schedules
and policies, coverage data, past campaigns and available data on disease incidence will help
highlight any challenges with data quality as well as areas for potential improvement. For broader
tetanus control, serosurveys can be used to:
• document evidence needed for tetanus immunization policy or strategy change (Td campaigns,
introduction of recommended booster doses, school-based immunization, etc.);
• monitor impact of tetanus vaccination programmes, including changes in policy and strategies
for greater effectiveness, such as catch-up vaccination, vaccination campaigns and strengthening
ANC;
• verify adequate tetanus population immunity needed for disease control goals, and compare
with other programme data (such as coverage and surveillance) as a means of independent
validation;
• identify areas and subgroups (sex, age group, parity status, migrant status, ethnicity) with low
tetanus seroprotection to appropriately design interventions (outreach, catch-up vaccination,
campaigns, school-based vaccination).
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Annex 11. Methodology for a post-validation assessment of MNTE
(The forms/questionnaires are available to be downloaded from WHO website -
https://www.who.int/immunization/diseases/tetanus/en/)
A post-validation assessment of MNTE is an in-depth exercise to check that elimination status is

being maintained. It can be undertaken periodically in any country that has achieved MNTE
elimination status, but in particular, it is relevant for those who have concerns about the
sustainability of their programme performance (e.g. declining EPI immunization coverage,
implementation and management problems, humanitarian crisis or natural disaster, etc).
A post-validation assessment of MNTE requires sufficient time to plan and complete the following:
— conduct a comprehensive desk review;
— synthesize the findings of the desk review;
— undertake district risk categorization;
— complete a root cause analysis or field assessment (if needed);
— identify corrective actions and develop/endorse a MNTE priority action plan and budget for
the implementation of proposed activities.1
It is essential that the national EPI, MNCH and surveillance managers, together with partner
representatives, are involved throughout the post-validation assessment of MNTE. Regional and
district EPI, MNCH and surveillance managers participate once the districts are identified.
In order to conduct the post-validation assessment of MNTE, it is critical that reliable NT

surveillance2, vaccination and SBA coverage data, along with expert knowledge, are available to
enable the accurate district categorization of potential risk for NT. Data for the past three years need
to be compiled so that coverage trends can be reviewed.
Five steps to complete a post-validation
There are five steps to complete a post-
assessment of MNTE:
validation assessment of MNTE which are Step 1: Determine risk indicators (core, surrogate,
described below. additional).
Step 2: Collect and compile data for each district.
The approach uses core and surrogate risk
Review data and adjust risk cut off points if
indicators for MNT (see Table 1) over the past needed.
three years which are compiled and reviewed to Step 3: Review each district and classify them into
identify and classify districts at risk. Additional risk categories (‘low risk’, ‘high risk’, or ‘at risk’)
indicators of interest may be added to extend based on their level of performance and expert
the review of district performance beyond MNT. input.
Step 4: Conduct in-depth analysis for selected
The review process is complemented by the use districts to identify corrective actions.
of expert knowledge of the potential risk for NT Step 5: Create a MNTE action plan for
before the final classification of the districts’ risk implementation of proposed activities.
1
All activities should be detailed and budgeted in country annual plans, which can then form the basis for local plans of
action.
2
Reliable NT surveillance: a) 0 cases notification functioning, b) completeness of district health facility surveillance
reporting ≥ 80%, c) annual review of hospital records at least once a year. This requires the following: 1. Case
definition of NT cases is available and known in all health facilities, 2. Case investigation forms for suspected cases
are available and cases are investigated, 3. In rural districts, there is functional community level surveillance.
123
status. The assessment exercise can be completed as a desk review or it may include field
assessments to selected districts.
STEP 1 (2 to 3 weeks): Determine risk indicators, collect and compile data for each district
Using Table 1 the post-validation assessment team leader should gather all the administrative data,
as well as from surveys (e.g. MICS, DHS, coverage surveys) to cross-check reported coverage data and
guide any adjustments that need to be made (see Step 2). Data for each district over the past three
years should be compiled in a concise and easy to read format. An example template spreadsheet is
available at WHO website (https://www.who.int/immunization/diseases/tetanus/en/).
Table 1
Indicators for MNT risk assessment
Additional indicators of
Core indicators Surrogate indicators
interest (examples)
- reported number of NT cases - ANC1 coverage - urban vs. rural district
- reported NT rate/1000 LB per - ANC 4 coverage - geographic accessibility
district - DTP1/Penta1 coverage - health infrastructure
- skilled birth attendance (SBA) - DTP3/Penta 3 coverage - other human development
coverage - MCV1 coverage indicators
- district level data for coverage - TTCV booster coverage -percentage, absolute
TTCV2+ and PAB - survey based coverage number and clustering of un-
- TTCV2+ coverage (for calculation estimates (EPI-CES/MICS/ or under- vaccinated infants
see Chapter 3): DHS) by years, for - % pregnant women never
• For pregnant women comparison with reported attending ANC1, and/or
(routine EPI) data (HMIS or EPI or WUENIC delivering in absence of a
• For WRA (age group as data) SBA
defined by the country) by
TTCV SIAs and year of
implementation
Data can be found from the following sources:

— Health management information system (HMIS)
HMIS data may show an over- or underestimate of performance indicators compared to survey
data due to incomplete and/or untimely reporting, inaccurate numerators and denominators
(e.g. outdated census, internal migrations, etc.), and the classic under- or over- reporting of NT
cases (i.e. not reaching reporting sites and/or cases not confirmed by case investigation).
— WHO and UNICEF Estimates of National Immunization Coverage (WUENIC)
WUENIC estimates3 which are revised annually, can serve to assess if reported national coverage
data are under- or overestimated. Local knowledge or coherence between ANC coverage and
reported TTCV2+, as well as DTP3/Penta3 coverage, may provide additional information for the
review of district performance.
— Recent (within the past 3 years) population health surveys (vaccination coverage surveys,
MICS, DHS, etc.)
Although population health surveys assess national/regional and rarely district coverage
performance, information obtained from these surveys, along with expert knowledge, may be
3
WHO. Data, statistics and graphics [online database]. Geneva: World Health Organization
(http://www.who.int/immunization/monitoring_surveillance/data/en/, accessed 15 January 2019).
124
helpful for the review and adjustment of under- or overestimated reported coverage for TTCV2+,
other antigens, PAB, and SBA.
STEP 2 (1 day workshop): Review and adjust risk cut-off points if needed
In a one-day workshop, the collected data compiled in the spreadsheet should be carefully reviewed
and analysed by the assessment team. If there is a discrepancy between any very recent
MICS/DHS/immunization coverage surveys and WUENIC data, the cut-off points for indicators in
districts can be adjusted if supported by evidence and upon consensus of all team members.
Practical experience conducting post-validation MNTE assessment has found that it is often
necessary to make cut-off adjustments in order to make the exercise manageable and focus on the
districts likely at highest risk. Some further explanation and guidance regarding possible adjustments
is provided below.
— NT rate cut-off point adjustment

By definition, if there is <1 NT case per 1 000 live births reported in a district4, in the presence of
reliable NT surveillance system73, the district will be classified as ‘low risk’. In the presence of
unreliable/weak NT surveillance, the cut-off point may be lowered to 0.5 cases per 1 000 live
births or as agreed.
— SBA coverage cut-off point adjustment
To attain MNTE status, the MNTE validation survey uses a Lot Quality Assurance Cluster Sample
(LQA-CS)5 to assess that at least 70% of reported deliveries were in the presence of a SBA.
However, for the post-validation assessment exercise, if needed this risk cut off-point can be
adjusted to 60%. This is because reported SBA coverage remains a conservative estimate of the
extent of clean birth practices due to the following reasons:
1. Deliveries in private clinics and home deliveries in presence of a SBA are often not accounted
for in the HMIS reports. This underestimates urban SBA coverage.
2. A portion of home deliveries may not be attended by SBA (as defined by the country), but
still adhere to the principles of Six Cleans (see Chapter 4).
— TTCV2+ coverage cut-off point adjustment
Major differences may be noted in some countries between administrative reported TTCV2+
coverage (e.g. included in the WHO/UNICEF Joint Reporting Form) and TTCV (PAB) protection
from coverage surveys. These coverage surveys take into account all TTCV doses ever
administered through routine or SIAs and not just TTCV2+ of a given year. However, TTCV (PAB)
protection from coverage surveys may still underestimate the true level of protection, as it
excludes routine doses of TTCV administered during infancy.
When compared with survey results (EPI-CES, DHS, MICS), TTCV2+ administrative coverage at
national and subnational levels can differ. This may be due to the following reasons:
— Pregnant women who completed the five-dose schedule are not eligible for another
TTCV dose and often are not accounted for in the TTCV2+ coverage in the administrative
reports (see Chapter 3 for correct formula to be used for TTCV2+ calculation)
4
In very large districts it may be necessary to consider sub-district analysis to verify clustering.
5
WHO (2014). Validation of Maternal and Neonatal Tetanus Elimination (including a guide to the use of Lot
Quality Assurance – Cluster Sample Surveys to assess neonatal tetanus mortality). Geneva: World Health
Organization.
125
— Pregnant women often receive a dose of TTCV vaccine in each pregnancy without taking
previous history into account, especially in the absence of documented history such as
through vaccination cards (as a result TTCV1 doses are de facto TTCV 2, 3, 4 or 5).
— TTCV doses administered during TTCV SIAs are not counted in the routine administration
of TTCV doses at ANC contacts (i.e. history of past TTCV SIA doses is rarely asked at ANC,
therefore these doses are not included in the routine administrative reporting of TTCV2+
coverage).
For the above reasons, although the TTCV2+ coverage of at least 80% is compatible with MNTE
status, the TTCV2+ district coverage cut-off point to be used in the post-validation assessment may
be adjusted to 70% if agreed/justified. However, the rationale for making this adjustment should be
based on country and district specificities.
STEP 3 (same 1 day workshop): Review each district and classify them into the following risk
categories ‘low risk’, ‘high risk’, or ‘at risk’, based on their level of performance.
Following the WHO algorithm (Figure 1):

— Review the NT rate for each district, based on the agreed cut off point (1/1 000 LB or adjusted
0.5/1 000 LB):
— If reported NT rate is higher than the cut-off point, classify the district as ‘high risk’.
— If the reported rate is lower than the cut-off point, further evaluate the district, based
on the reliability of the NT surveillance system.
— Evaluate the reliability of the NT surveillance73:
— If the surveillance system is reliable, classify the district as ‘low risk’.
— If deemed unreliable, continue evaluation of the district using SBA coverage.
— Review the district for SBA coverage6:
— If SBA coverage in the district is equal to or greater than the agreed upon cut-off point
(i.e. ≥60%), classify the district as ‘low risk’.
— If the district SBA coverage is lower than the cut-off point, evaluate the district further
for TTCV2+ or PAB coverage.
— Review TTCV2+ or PAB coverage:
— If the TTCV2+ coverage in the district is equal to or greater than the agreed upon cut-
off point (i.e. ≥70%), classify the district as ‘low risk’.
— If the district TTCV2+ coverage is lower than the cut-off point, classify the district as
‘at risk’.
— Review ‘at risk’ districts and further classify them into ‘medium risk’ or ‘high risk’.
— Classify ‘at risk’ districts into ‘medium risk’ if any of these criteria apply:
• Reported SBA coverage: 40–60%, or
• Reported TTCV2+ coverage: 50–70%, or
• Reported both ANC1 and DTP/Penta3: 60%–85%.
— If none of the above applies, classify remaining ‘at risk’ districts as ‘high risk’.
6
Delivery by a skill health personnel or as defined by the national policy (see Chapter 4)
126
Where risk is unidentified because of lack of data (i.e. silent areas) the district should be deemed as
‘high risk’ as it is likely to have unreported NT cases.
Figure 1
WHO algorithm to classify potential risk of NT in districts (Step 3 of MNT risk assessment)
NT rate <1/1000 LB?
NO YES
HIGH RISK Reliable NT surveillance?*
NO YES
LOW RISK
Assisted delivery (SBA) coverage ≥60%?**
NO YES
LOW RISK
TTCV2+ or PAB coverage ≥70%?
NO YES
LOW RISK
AT RISK
SBA 40-60% or SBA <40% or

TTCV2+ in pregnant TTCV2+ in pregnant
women 50-70% women <50%
ANC1 and DTP/Penta3 ANC1 and DTP/Penta3
˃60% <60%
MEDIUM RISK HIGH RISK
* Reliable NT surveillance: a) 0 cases notification functioning, b) completeness of district health facility

surveillance reporting ≥80%, c) annual review of hospital records at least once a year. This requires the
following: 1. Case definition of NT cases is available and known in all health facilities, 2. Case investigation
forms for suspected cases are available and cases are investigated, 3. In rural districts, there is functional
community level surveillance.
** Delivery by skilled health personnel or as defined by the national policy.
127
STEP 4 (1 week): Conduct in-depth analysis for selected districts to identify corrective actions
Based on findings from the desk review and district classifications, two approaches can be
undertaken to conduct in-depth analysis for selected districts.
1. Conduct field assessment using standardized tools

The field assessments should be conducted using standardized tools (e.g. district assessment forms,
available at WHO website – https://www.who.int/immunization/diseases/tetanus/en/) in one ‘low
risk’ (e.g. high performing) district, to document best practices, and two ‘at risk’ (e.g. lower
performing) districts, to document possible weaknesses and recommendations for improvement.
The standardized tools for the field visits are designed to confirm if the districts have been able to
sustain MNTE status since the country achieved its elimination. The field assessment evaluates the
current risk of MNT through visits to district health offices; referral hospitals; health facilities, and
communities with women who had a child in the previous two years.
Activities during field assessments include:

• review of registers, microplans, vaccine stock records to assess whether TTCV2+ is over or
underestimated;
• examination of reports of NT cases to see if there have been misdiagnoses, or if the cases
belonged to other districts (e.g. referral cases);
• review of the NT surveillance procedures, including if and how referral hospitals record
reviews are performed, if there is active/community-based surveillance and community
sensitization in rural areas;
• discussions with local health workers and authorities, including hospital paediatric ward staff,
to get an impression of the general state of health services in the area and to obtain any
additional reports and information;
• review of earlier reports on district performance (surveys, service or surveillance evaluations,
etc.);
• interviews with a sample of women who had a child in the previous two years to assess their
level of TTCV2+ protection based on history of all TTCV doses ever administered during past
TTCV SIAs and during past pregnancies, their frequency of missed opportunities for TTCV
administration, use of ANC services, PAB, typical delivery conditions, cord care practices, and
perceptions about service availability and reliability.
All evidence gathered from the field assessments should be compiled and analyzed, with findings
summarized, including key indicators: number of women interviewed, TTCV2+, TTCV5+ coverage,
proportion of births in health facilities, proportion putting traditional substance on cord, proportion
of women and deliveries protected against tetanus by combined TTCV and skilled birth attendance.7
The assessment team, comprising of EPI, MNCH, surveillance managers and partner representatives,
should consider again whether it is likely that MNTE elimination has been sustained, and if
weaknesses have been identified, how they should be addressed (see Step 5).
2. Root-cause analysis (RCA)

As an alternative to conducting field visits, an in-depth analysis can also be done by completing a
root-cause analysis (RCA) of ‘at risk’ districts to further assess and identify causes for low
performance. To facilitate the RCA, certain indicators relating to EPI and MNCH programme
7
WHO [website]. Debriefing slide set example (https://www.who.int/immunization/diseases/tetanus/en/).
128
components e.g. TTCV2+ vaccination, focused antenatal care, and SBA need to be examined for
programme and related management issues (see Table 2).
Table 2
Examples of indicators to be examined in the root cause analysis (RCA) per programme component
Programme
Indicator
component
Commodities:
— Proportion of facilities reporting stock-outs of TTCV vaccine for more than 7
days in the previous 3 months
Human resources:
— Proportion of facilities without trained nurses and midwives
Vaccination
coverage with Access:
TTCV and PAB — Existence of RED/REC plan (fixed/outreach/mobile teams)
coverage — Proportion of outreach and mobile sessions conducted in last 3 months
Quality:
— Proportion of pregnant women who were protected for tetanus (TTCV2+)
and/or PAB
— If implementing child or adolescent TTCV booster doses, percentage of
children who received 6 TTCV doses by adolescence
Access:
— Proportion of pregnant women who had at least 1 ANC visit
Focused — Proportion of health facilities providing TTCV vaccination at ANC visits
antenatal care Utilization:
(ANC coverage) — Proportion of pregnant women who had at least 4 ANC contacts
Quality:
— Proportion of pregnant women who attended ANC within the first trimester
Human resources:
— Proportion of facilities with skilled health care workers (doctors, nurses,
Skilled birth midwives)
attendance Access and utilization:
(SBA coverage) — Proportion of live births delivered in a health facility
Quality:
— Proportion of deliveries who received postnatal visit within 24 hours.
It is essential to document and summarize the findings on issues and barriers to allow for their
prioritization and to determine the necessary corrective actions (Step 5).
Step 5 (1 day workshop): Create a MNTE priority action plan for implementation of proposed
activities for action
For each of the issues identified through the in-depth analysis (Step 4), proposed corrective
interventions should be consolidated into a MNTE priority action plan (see example of an outline in
Table 3) during a workshop attended by EPI, MNCH, surveillance managers and partner
representatives.
The MNTE priority action plan should also include immediate next steps, timeline for completion, and
should identify the responsible person/organization, budget requirements and source of funding (if
needed).
129
Table 3
Outline of MNTE priority action plan with examples of identified issues and proposed interventions
Immediate next Timeline for Budget/funding Responsible person/

Main issues identified Proposed interventions for action
steps completion source (if needed) organization
Example Example
Underutilization of TTCV - Map unreached and revisit RED/REC
vaccination services due to: microplanning to ensure all pregnant
- Insufficient number of women are within 5km of a vaccination
outreach teams site
- Limited access to ANC - Ensure at least 6 vaccination sessions per
services year for outreach
- Poor mobilization and - Consider 2-4 PIRI per year for very hard-
under-vaccination of to-reach populations
pregnant women at outreach - Include additional interventions in PIRI
sites (with or without ANC) based on community needs
- Insufficient involvement of - Community-level identification and
CHWs tracking of eligible women and infants,
- TTCV vaccine stock out with defaulter tracing
- Underestimation of TTCV2+ - Organize periodic review meetings with
coverage due to monitoring health facility workers and community
deficiencies representatives and CHWs
- Weak and unreliable NT - Allocate required additional resources to
surveillance due to poor reach all target population
health worker understanding -Distribute case definition of NT cases to
Etc. all health facilities and provide refresher
training via supportive supervision
-Ensure that case investigation forms for
suspected cases are available in all
facilities and cases are investigated
130
131

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Protecting All Against Tetanus

Guide to sustaining maternal and neonatal tetanus elimination (MNTE)

FINAL PRE-PRINTING VERSION

© World Health Organization 2019

Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris.

Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders.

Annex 1. What is tetanus? ................................................................................................................ 80

This document was developed by the Expanded Programme on Immunization (EPI),

AEFI Adverse event(s) following immunization

The specific objectives of this guide are:

In this introductory chapter you will learn:

You can use this information to:

The burden of maternal and neonatal tetanus

Maternal and Neonatal Elimination (MNTE) Goal: key details

• As a result of implementing recommended strategies in the period 1988–2015, the

How can protection against tetanus and MNTE be sustained?

ACHIEVING MNTE SUSTAINING MNTE

Strengthen antenatal care (ANC) Strengthen immunization of pregnant

TTCV Supplementary Immunization Antenatal screening of pregnant women to

Strong T/NT surveillance and regular

Sustaining MNTE requires a comprehensive multi-pronged approach. In the short to

2. Building routine immunization (3 primary infant and 3 booster

In this chapter you will learn:

You can use this information to:

WHO recommendation: routine vaccination schedule for TTCV

What TTCVs can be used for the childhood vaccination schedule?

Tetanus toxoid is available in a single-antigen vaccine (TT) and in combination vaccines

See WHO vaccine position papers at http://www.who.int/immunization/documents/positionpapers/en/.

Why use tetanus-diphtheria containing combination vaccines (DT/Td)

WHO/UNICEF Guidance Note on replacing TT with Td

Are TTCVs safe?

High vaccination coverage depends on well-functioning immunization programmes, strong

Reaching Every District (RED) approach*

Global Routine Immunization Strategies and

Reaching Every District (RED), 2017 Edition – a

Reducing Missed Opportunities for Vaccination

Periodic Intensification of Routine Immunization

Guide to Tailoring Immunization Programmes

Training for Mid-Level Managers (MLM) – 8

A Guide to Introducing a Second Dose of Measles into

Establishing and strengthening immunization in the

A companion resource to the WHO publication

(ii) 2nd TTCV Booster at 4–7 years

A day-care/crèche- or school-based vaccination strategy is an option, as 4–7 years is the age

Opportunities should be sought to link the introduction of HPV vaccination to other

Global commitment to adolescent health

Adolescent health and development was made an integral part of the

The Global Accelerated Action for the Health of Adolescents (AA-HA!):

A multimedia interactive report, Health for the World’s Adolescents: A

A guide to introducing HPV vaccine into national

Resources on delivery strategies:

Scaling up HPV vaccine introduction (2016) – provides a

HPV Vaccine Lessons Learnt – comprehensive review of

HPV Vaccine Communication: Special considerations

Options for linking health interventions for adolescents

Vaccination at health facilities

School-based (outreach) strategy

School Vaccination Readiness Assessment Tool – provides

School multi-age cohort Td vaccination strategy