Holding Company for

Biological Products & Vaccines

Dr: Mostafa Mohamady
General manager of vaccines
A Glance At Vaccines
 VACSERA
A Continuous Progress Story
 …Vacsera is a state owned company
which began as a small laboratory established in
1897 by Health Dept. producing small-pox vaccine
followed by Rabies vaccine in 1907.. still the only
co. producing vaccines in Egypt.
… In 2002 Vacsera was announced as a Holding
Company for Biological Products & Vaccines having 3
affiliated companies in 3 main locations.
 Vision …
To maintain our leadership in
producing, developing and marketing of
biological products & vaccines for the local
market and the whole region, and to keep
pace with technological progress and global
competition.
 Mission …
To contribute in securing the needs of the
country from vaccines (human & veterinary),
biotechnological products, blood & blood components,
and some other projects to achieve a reasonable profit
margin to help in the company growth, implementing
continuous improvement to all activities, resources
and assets of the company.
Types of vaccines
Attenuated

Some vaccines contain live attenuated

microorganisms. They are cultivated under
conditions that disable their virulent
properties. Examples include the viral
diseases yellow fever, measles, rubella, and
mumps.
 Inactivated (Killed)
Some vaccines contain killed, but previously
virulent, micro-organisms that have been
destroyed with chemicals, heat, radioactivity or
antibiotics. Examples are the influenza vaccine,
cholera vaccine, injectable polio vaccine,
hepatitis A vaccine, and rabies vaccin
 Toxoid
Toxoid vaccines are made from
inactivated toxins that cause illness.
Examples include tetanus and diphtheria
.
Polysaccharide
A noninfectious vaccine that contains the
polysaccharide coats, or capsules of
encapsulated bacteria e.g: Pneumococcal
& Meningococcal vaccines.
Conjugate
Certain bacteria have polysaccharide outer
coats that are poorly immunogenic.
By linking these outer coats to proteins
(e.g. toxins), the immune system can be led
to recognize the polysaccharide as if it were a
protein antigen. This approach is used in the
Haemophilus influenzae type B vaccine(.
Recombinant
HBV and Human Papilloma virus vaccines
(HPV)
Vaccine Schedules
in Egypt
 NIP
schedule in Egypt
Additional recommended vaccines
Age Vaccine Dose Route of administration

months 2 PCV ml 0.5 I.M

Rota drops Oral

months 4 PCV ml 0.5 I.M

Rota drops Oral

months 6 PCV ml 0.5 I.M

Rota (according to brand) drops Oral

months 12 Varicella & Hepatitis A ml each 0.5 S.C & I.M

months 18 PCV ml 0.5 I.M

months 24 Hepatitis A (2nd) ml 0.5 I.M

Meningococcal ml 0.5 S.C
Varicella (2nd) ml 0.5 S.C

years 4-6 BCG ml 0.1 I.D

Meningococcal ml 0.5 S.C
Add.Vaccines
 Haemophilus Influenza
type B (Hib) vaccine
- Indications:
Protection against a variety of invasive syndromes, such as
Meningitis, Pneumonia and Otitis Media, and caused by
Haemophilus influenzae bacteria.
- Nature:
Conjugate vaccine

- Dose: 0.5 ml

- Route of administration: By I.M injection

:Schedule -
- 2 to 6 months: 3 doses + booster at 12-15 months.
- > 6 to 12 months: 2 doses + booster at > 12 months
- > 1 year: one dose
- > 5 yrs: not indicated unless immunocompromised
- Side effects:
- Redness, warmth, or swelling were the shot was given (up to 1/4 of
children)
- Fever over 38° C (up to 1 out of 20 children)
If these problems happen, they usually start within a day of
vaccination. They may last 2-3 days. 
 Precautions:
 To be administered immediately after reconstitution or
maximum 8 hours after reconstitution
 Pneumococcal vaccines
(PCV)
- Indications:
Routinely taken to protect against Pneumonia, Meningitis and Otitis Media
caused by Pneumococcal Streptococci.
- Nature:
Conjugate Vaccine
- Dose & Schedule:
- 0.5 ml: starting from 2 months:
- If 2-6 months: 3 doses + 4th at 12-15 months of age.
- ≥6-12 months: 2 doses + 3rd in 2nd yr (at least 2 months after 2nd dose).
- ≥12-24 months: 2 doses with at least 2 months apart
- ≥24 months - 6 yrs: one dose
- Also recommended for people ≥ 50 years
- For ages between 6 and 50 years, patients with underlying medical
conditions are recommended to receive one dose of the vaccine.s
- Route of administratio:
By I.M injection

:Side effects -
.Redness, tenderness, or swelling where the shot is given & fever

:Contraindications -
.Not to be taken before age 6 weeks or after age 5 years
 Rotavirus vaccine
- Indications: Protection against Rotavirus Gastroenteritis

- Nature: Live attenuated vaccine.

- Route of administration: oral drops.

 Dose & schedule:

- 2 or 3 doses (according to brand used).

- The minimum age for the 1st dose is 6 weeks.
- The maximum age for the 1st dose is 15 weeks
- The minimum interval between the doses is 4 weeks.
- The maximum age for the last dose is 8 months.
- Side effects:
Minimal
- Precautions:

It can be given concomitantly with oral polio vaccine without significant

impairment of vaccine effectiveness. If they are not given simultaneously
then they must be separated by at least 14 days (preferred option).

There are no restrictions on the infant’s consumption of food or liquids,

including breast milk, either before or after vaccination.

- Contraindications:
- Immuno compromised patients
- Before age 6 weeks or after 8 months.
 Hepatitis A vaccine
:Indications -
.Protection against Hepatitis A virus in contaminated food and drinks
:Nature -
Inactivated vaccine
:Dose -
years: 0.5 ml 1-18
> 18 years: 1 ml
- Route of administration:
By I.M injection
:Schedule -
Two doses with 6-12 months in between
1ST dose confers protection after 2-4 weeks.

:Side effects -
± Soreness where the shot was given, headache, loss of appetite &
tiredness.

:Precautions and contraindications -

.Below age 1 year
 Varicella Vaccine
Nature: Live attenuated Varicella – Zoster virus-
Indications: Prevention of Chicken Pox-
Dose: 0.5 ml-
Route of administration: S.C injection-
:Number of doses-
- Ages 1-13 years:
- 1st dose of vaccine from the age of 12 months.
- 2nd dose at 4-6 years (or after the 1st dose by at least 3
months)
- Ages ≥ 13 years:
- Two doses of vaccine are needed with a minimum interval of

4 apart.
:Precautions -
- Simultaneous administration with other live vaccines
- Salicylates & Reye Syndrome
- Reception of blood products or human immunoglobulin

- Side effects:
Some local swelling & redness at the site of injection during the
first hours following vaccination (27%), & in a few cases (fewer than
5%) a mild varicella-like disease with rash within 10-14 days.

- Contraindications for Varicella vaccination:

- Pregnancy
- Immunocompromised patients.
 Influenza vaccine
-Indications:
Especially important in infants and old age (>65 yrs), chest and
cardiac patients and patients with chronic diseases.

- Nature:
Inactivated vaccine
- Dose :
- 6 months to 3yrs: 0.25 ml
- >3 years: 0.5 ml
- Route of administration:
By I.M injection
- Schedule:
Those who are < 9 years old and were NOT previously vaccinated
need 2 doses with at least 4 weeks apart.

Any age < 9 years old who had a previous Flu shot at any age need
1 dose only.

Any age > 9 years even if not previously vaccinated need 1 dose
only.
- Side effects:

±Local soreness, redness, or swelling, fever & aches.

- Contraindications & Precautions:

- Allergy to egg protein
- Below age 6 months
Meningococcal Vaccine
-Indications:
Prevention of Meningococcal meningitis (caused by Neisseria Meningitidis).
-Nature:
Polysaccharide vaccine

-Dose: 0.5 ml
-Route of administration:
Subcutaneous injection
-Schedule:
- Single dose
- Given at 2 years and above
- Protection provided lasts for 2-3 years
-Side effects:
Redness or local pain and fever

-Contraindications:
< 2 years
- Precautions:
- Reconstituted Meningococcal vaccine can be stored for up to 6-8
hours in temp. (+2°C to 8°C).
- Light
Combined Hepatitis
A & B vaccine
:Indications
Protection against Hepatitis A virus in contaminated food and drinks as
.well as Hepatitis B infection

:Nature
Combined inactivated Hepatitis A vaccine with recombinant B vaccine
.in a pre-filled syringe

:Route of administration
.I.M injection in Deltoid ms
 :Doses & schedule -
.ml injection in a 3-dose schedule at intervals of 0, 1 & 6 months 1

:Side effects -
Those of Hepatitis A & B vaccines

:Precautions and contraindications -

Below age 16 years
we have also
…
Cholera vaccine

Typhoid Vaccine

Yellow Fever vaccine

Human papilloma virus vaccine

Rabies vaccine
Anti snake srum
Anti scorpion serum
 anti tetanic serum
Anti rabies IG
Anti hep.b IG
Iv IG
 Combined vaccines
- Penta vaccines:
- DwPT + Hib + Hepatitis B
- DaPT + Hib + IPV

- Tritanrix vaccine:
- DwPT + Hepatitis B
- Hepatitis A + Hepatitis B
 …Quality Management & EHS
The quality system is being implemented by
establishing quality concepts in the minds of all
workers, through continuous quality awareness
training programs. This system depends
on TQM and international quality STDs:
- ISO 9000 - 2000
- ISO 14000
- ISO 18000
International standards for pharmaceuticals & biological products:
• WHO regulations for biological manufacturing.
• FDA code of federal regulations for health & human services
(GXP)
• AABB standards for blood banking.
 Rabies vaccine
- Indications:
Prevention of Rabies (fatal disease) following a bite, and possibly a scratch, from a rabid
animal.
-Nature:
Killed (inactivated) vaccine
-Dose:
1 ml or 0.5 ml depending on the vaccine brand
-Route of administration:
By I.M injection
- < 18months: Anterolateral aspect of thigh
- > 18months: Deltoid muscle
Do not inject into gluteal ms. because it will induce inadequate immune response.
-Schedules:
- Pre-exposure prophylaxis:
Vaccine given in a 3-dose series; at 0, 7 & 21 (or 28) days
A booster can be given every 2 yrs for high risk individuals (veterinarians, lab staff,
.animal handlers & visitors or travelers to areas with high risk of rabies)
If exposure occurs in previously vaccinated individuals then 2 doses only of Rabies
.vaccine can be given; at 0 time and 3 days after. Rabies immune globulin is not needed
- Post-exposure prophylaxis:
Vaccination alone is required in cases of handling uncovered skin, minor
scratches or abrasions without bleeding or licking on broken skin,while cases
with bites or scratches with bleeding or contamination of mucous membrane
with saliva from licks require both immediate vaccination and
administration of human rabies immune globulin.
:First aid measures -
The wound should be washed thoroughly with water & soap. Disinfect with
povidine-iodine.
:then the following is done
In previously vaccinated individuals (either by pre exposure or post exposure
vaccination), the Rabies vaccine is given at 0 time and 3 days after. Human
Rabies immunoglobulin is not needed.
In previously unvaccinated individuals, the vaccine is given in a 0, 3, 7, 14 & 28
days schedule. The first dose is given with human Rabies immune globulin
(HRIG) at the same time (up to the 7th day). A dose of 20 IU/kg is required,
half of which is infiltrated into and around the wound and the remainder is
administered in a separate injection site from the vaccine by intramuscular
injection (Deltoid, Anterolateral aspect of the thigh or Gluteal muscle).
- Precautions:

- Live attenuated virus vaccines such as measles, mumps, rubella and

varicella should be administered at least 14 days prior to or 3 months after
administration of Human Rabies immunoglobulin.
- Stop treatment (vaccination process) if animal remains healthy
throughout an observation period of 10 days or if animal is humanely
killed and found to be negative for Rabies using appropriate diagnostic
techniques. 
- Suturing should be postponed, but if necessary then infiltrate the wound
area with half the dose of immunoglobulin first.

- Side effects:
Local reactions might occur.
 Cholera vaccine
- Indications:
Protection against Cholera
- Nature:
Phenol Killed vaccine containing killed Vibrio Cholerae
- Doses & Schedule:
Two doses, 1- 4 weeks apart:
- 6 mos-10yrs: 0.25 ml for each dose.
- > 10 yrs: 0.5 ml for each dose.
Booster schedule:
Every 6 months in endemic areas.

- Route of administration:
I.M or deep S.C injection.
- Side effects:
- Local reactions: Erythema, induration, pain and tenderness.
- Systemic reactions: Malaise, headache and fever.
- Contraindications:
Below age 6 months
 Yellow Fever vaccine
-Indications:
Protection against Yellow Fever virus which causes acute viral
haemorrhagic disease that is fatal. The virus is transmitted by certain
types of infected mosqitoes in tropical and subtropical areas in South
America & Africa.
-Nature:
Live attenuated vaccine
-Dose:
0.5 ml
-Route of administration:
S.C injection
-Schedule:
Any age > 9 months
Single dose, providing protection within 10 days for at least 10 years. It
is given to all travelers to endemic areas.
:Contraindications -
Infants under 6 months of age -
Egg allergy -
Immunodeficiency -
Pregnancy -
:Side effects -
Rarely, mild headache, muscle pain, or other minor symptoms
5 to 10 days after vaccination.
Very rarely, encephalitis.
:Precautions -
Egg allergy
 Typhoid Vaccine
Indications:
Prevention of infection with Salmonella Typhi which causes Typhoid fever.
-Nature:
Heat-phenol killed vaccine containing whole cells of killed typhoid bacilli
-Doses & Schedule:
- Two doses with an interval of 4 weeks or more:
- 6 months-10 yrs: 0.25 ml per dose
- > 10 yrs: 0.5 ml per dose
-Route of administration:
S.C injection
Protective efficacy lasts for 3 years
-Side effects:
Local: Erythema, induration, at the site of injection.
Systemic manifestations: Malaise, headache, myalgia, and Fever.
-Contraindications:
Below age 6 months
 Human papilloma virus
vaccine
-Indications:
Prevention of Human papilloma virus which causes Cancer Cervix.

-Nature:
Recombinant vaccine

-Dose:
0.5 ml

-Route of administration:
I.M injection(deltoid muscle(

-Schedule:
Intended for use in females aged 10-45 years.
The vaccine is given in a series of 3 injections over a 6-month period. The 2 nd
and 3rd doses should be given at 1 and 6 months (respectively) after the 1 st dose.
:Side effects-
Pain or discomfort at the injection site
Hedness or swelling at the injection site
Headache -
Muscle pain or weakness -
Fever -
GIT upset -

:Precautions & Contraindications-

.Not to be taken during pregnancy
 Pneumococcal Polysaccharide
Vaccine (PPV)
-Indications:
Prevention of streptococcus Pneumoniae infection to which the following
groups are more liable:
years age 65 > -
Anyone over two years of age who has a long-term health problem such as
splenectomy, Nephrotic syndrome, heart disease, sickle cell anemia, chest
disease, diabetes, liver cirrhosis, organ transplant or immunocompromised
.patients (chemotherapy, steroids)
-Nature:
Polysaccharide vaccine
-Dose & Schedule:
0.5 ml starting from the age of 2 yrs
Single dose every 3 years
-Route of administration:
I.M or deep S.C injection

-Side affects:
About half of those who get the vaccine have very mild side effects,
such as redness or pain where the shot is given.

-Contraindications:
Ages below 2 years
 Combined vaccines
- Penta vaccines:
- DwPT + Hib + Hepatitis B
- DaPT + Hib + IPV

- Tritanrix vaccine:
- DwPT + Hepatitis B
- Hepatitis A + Hepatitis B
 BCG vaccine
- Indications:
For prevention of T.B

- Nature:
Live attenuated

- Dose & Schedule:

Starting from birth
- < 1 yr: 0.05ml - ≥ 1 yr: 0.1 ml

- Route of administration:
I.D injection in Lt. Deltoid area.

- Precaution:
- The reconstituted vaccine may remain at +2°C to 8°C for up to a period of 4 to
6 hrs (according to the brand used).
- Avoid exposure of vaccine to light.
- The intradermal route is a must.
- Reaction to BCG vaccine:
A local reaction after BCG is normal. Small tender red swelling
(induration) → small pustule →ulcer in 2-4 weeks.

The reaction usually subsides within a few months and heals

normally leaving a superficial scar.

- Contraindications:
- Immunocompromised patients
- Positive Tuberculin reaction
 DPT Vaccine
- Indications:
Prevention of Diphtheria, Tetanus & Whooping cough.
:Nature -
Combined vaccine formed of Diphtheria toxoid, whole cell killed Pertussis &
.)Tetanus toxoid
:Dose -
ml 0.5
:Schedule -
- 3 primary doses at 2, 4 & 6 months of age.
- 1st booster at 18 months of age.
- 2nd booster at 4-6 years (DT is given).
Route of administration: By I.M injection-
< 18 months: Anterolateral aspect of thigh
> 18 months: Deltoid ms.
 :Side effects -
Local: Pain, swelling, redness & difficulty in limb mobility.

Systemic: It includes fever, anorexia, vomiting, irritability, excessive

crying.

- Contraindications:
Brain conditions, previous convulsions or high fever ≥ 40°C after
previous DPT dose.

- Precautions:
- See contraindications

- Cold fomentations locally over site of injection (1st 24 hrs)

- Close observation for fever (1st 48 hours) and management.

 Poliomyelitis Vaccines
- Indications:
Prevention of Poliomyelitis
- Nature:
Types 1, 2, & 3 Polioviruses. These three strains are all necessary for
an effective vaccine to prevent paralytic polio:
- Oral Polio vaccine (OPV): Live attenuated
- Injectable Polio vaccine (IPV): Inactivated (killed)
- Doses & Schedules:
- Oral Polio vaccine: 2 oral drops at 2, 4, 6 & 9 with boosters
at 12, 18 months & 4-5 yrs.
- Inactivated Polio vaccine: 0.5 ml by intramuscular injection with
same schedule as oral polio.
- Inactivated polio vaccine is the routinely administered polio vaccine
in developed countries.
- Side effects:
- Oral Polio vaccine: OPV very rarely causes vaccine associated
paralytic polio in a very small percentage of those immunized (one
every 2 million). It is more likely to occur in those with Immune
deficiency. IPV cannot cause paralysis, as the vaccine virus has been
inactivated.
- Inactivated Polio vaccine: ± local sore spot.
- Contraindications:
Immunocompromised children.
- Precautions:
- Immunocompromised patients should be separated from anyone
who received OPV for > 4-6 weeks.
- OPV remains potent until the expiry date indicated on the vial if
stored at not higher than -20°C.
- It can be stored for up to six months between +2°C and +8°C.
- Once opened, multi-dose vials should be kept between +2°C and
+8°C for up to 1 week provided that aseptic measures are taken & the
VVM has not reached the discard point.
 Hepatitis B vaccine
- Indications:
Prevention of Hepatitis B virus infection

- Nature:
Recombinant vaccine

- Dose:
0 -19 years: 0.5 ml
> 19 years: 1 ml

-Route of administration:
By I.M injection

- Side effects:
Minimal (maybe local tenderness and mild fever)
:Schedules
Infants: At 0, 1 & 6 months of age OR at 2, 4 & 6 months of age.
The minimum age for the 3rd dose is 6 months.
Children & adults: At 0, 1 & 6 months intervals.
At risk individuals: At 0, 1, 2 & 12 month's intervals.
Neonates born to Hepatitis B positive mothers:
Administer Hepatitis B vaccine and 0.5 mL of hepatitis B immune globulin
(HBIG) by I.M injection in the anterolateral aspect of the thigh within 12 hours
of birth (vaccine in one thigh and the immunoglobulin in the other thigh). Then
the vaccine is given again at 1 & 6 months of age.
Hepatitis C +ve patients: At 0, 1 & 6 months intervals
Renal dialysis patients: At 0, 1, 2 & 6 months intervals (double dose each
time).
Preterm infants weighing less than 2 kg should have their 1st dose of
Hepatitis B vaccine delayed till the age of 1 month unless the mother is HBsAg
positive.
 MMR Vaccine
- Nature:
Live attenuated vaccine
- Indications:
Prevention of Measles, Mumps & Rubella (German Measles).
- Two doses:
- The 1st at age 1 year
- The 2nd at 4-6 years (It can be given earlier as long as there
is a minimum of four weeks between the 2 doses.)
- Dose:
0.5 ml
-Route of administration:
S.C injection
-When is Measles vaccine given?
At 9 months (not anymore)
-Precautions:
+2°C to 8°C - 8 hrs (reconstitution)
-Side effects:
± local soreness, redness or swelling. Mild rash, mild to moderate
fever, swelling of the lymph glands, and temporary pain, stiffness, or
temporary swelling in the joints.
If these problems occur, it is usually within 7-12 days after the
shot.

-Contraindications:
- Pregnancy
- Immunocompromised patients

-Precautions:
- Women should not become pregnant within 3 months after
immunization with MMR.
- People receiving blood products (except washed red blood cells)
such as human immune globulin should have the MMR vaccine
deferred for at least 3 months.