Morbidity and Mortality Weekly Report

Incidence of Monkeypox Among Unvaccinated Persons Compared with

Persons Receiving ≥1 JYNNEOS Vaccine Dose — 32 U.S. Jurisdictions,
July 31–September 3, 2022
Amanda B. Payne, PhD1; Logan C. Ray, MPH1; Kiersten J. Kugeler, PhD1; Amy Fothergill, PhD1,2; Elizabeth B. White, PhD1,2;
Michelle Canning, MPH1; Jennifer L. Farrar, MPH1; Leora R. Feldstein, PhD1; Adi V. Gundlapalli, MD, PhD1; Kennedy Houck, MPH1;
Jennifer L. Kriss, PhD1; Nathaniel M. Lewis, PhD1; Emily Sims, MPH1; Dawn K. Smith, MD1; Ian H. Spicknall, PhD1; Yoshinori Nakazawa, PhD1;
Inger K. Damon, MD, PhD1; Amanda C. Cohn, MD1; Daniel C. Payne, PhD1

On September 30, 2022, this report was posted as an MMWR across 32 U.S. jurisdictions.** Average monkeypox incidence
Early Release on the MMWR website (https://www.cdc.gov/mmwr). (cases per 100,000) among unvaccinated persons was 14.3
Human monkeypox is caused by Monkeypox virus (MPXV), (95% CI = 5.0–41.0) times that among persons who received
an Orthopoxvirus, previously rare in the United States (1). The 1 dose of JYNNEOS vaccine ≥14 days earlier. Monitoring
first U.S. case of monkeypox during the current outbreak was monkeypox incidence by vaccination status in timely surveil-
identified on May 17, 2022 (2). As of September 28, 2022, lance data might provide early indications of vaccine-related
a total of 25,341 monkeypox cases have been reported in the protection that can be confirmed through other well-controlled
United States.* The outbreak has disproportionately affected vaccine effectiveness studies. This early finding suggests that
gay, bisexual, and other men who have sex with men (MSM) a single dose of JYNNEOS vaccine provides some protection
(3). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, against monkeypox infection. The degree and durability of
Bavarian Nordic), administered subcutaneously as a 2-dose such protection is unknown, and it is recommended that
(0.5 mL per dose) series with doses administered 4 weeks apart, people who are eligible for monkeypox vaccination receive the
was approved by the Food and Drug Administration (FDA) in complete 2-dose series.
2019 to prevent smallpox and monkeypox infection (4). U.S. Aggregate weekly numbers of confirmed and probable mon-
distribution of JYNNEOS vaccine as postexposure prophylaxis keypox cases†† among males aged 18–49 years with illness
(PEP) for persons with known exposures to MPXV began in onset§§ during July 31–September 3, 2022, were analyzed across
May 2022. A U.S. national vaccination strategy† for expanded 32 public health jurisdictions. These jurisdictions routinely
PEP, announced on June 28, 2022, recommended subcutane- ascertain vaccination status¶¶ through patient interview or link
ous vaccination of persons with known or presumed exposure cases with vaccination data from their immunization registries
to MPXV, broadening vaccination eligibility. FDA emergency and separately submit deidentified vaccine administration data
use authorization (EUA) of intradermal administration of to CDC. The analysis was limited to males aged 18–49 years to
0.1 mL of JYNNEOS on August 9, 2022, increased vaccine exclude persons who might have received routine smallpox vac-
supply (5). As of September 28, 2022, most vaccine has been cination in childhood. Persons with monkeypox were categorized
administered as PEP or expanded PEP. Because of the limited
amount of time that has elapsed since administration of initial ** Alaska, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas,
vaccine doses, as of September 28, 2022, relatively few persons Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri,
Montana, Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma,
in the current outbreak have completed the recommended Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee,
2-dose series.§ To examine the incidence of monkeypox among Utah, Virginia, West Virginia, and Wisconsin. Jurisdictions were included if
age and sex assigned at birth or gender identity was available for ≥70% of cases
persons who were unvaccinated and those who had received reported, vaccination status was available for ≥50% of cases in males (defined
≥1 JYNNEOS vaccine dose, 5,402 reported monkeypox cases by either sex assigned at birth or gender identity) aged 18–49 years or the
occurring among males¶ aged 18–49 years during July 31– jurisdiction confirmed cases are linked to immunization registry entries, and
de-identified vaccination administration data were submitted to CDC.
September 3, 2022, were analyzed by vaccination status †† Confirmed (presence of Monkeypox virus DNA by polymerase chain
reaction [PCR] testing or Next-Generation sequencing of a clinical
* https://www.cdc.gov/poxvirus/monkeypox/response/2022/us-map.html specimen OR isolation of Monkeypox virus in culture from a clinical specimen)
† https://www.hhs.gov/about/news/2022/06/28/hhs-announces-enhanced- and probable (presence of Orthopoxvirus DNA by PCR, or Orthopoxvirus
strategy-vaccinate-protect-at-risk-individuals-from-current-monkeypox- using immunohistochemical or electron microscopy or detectable levels of
outbreak.html anti-Orthopoxvirus immunoglobulin M antibody) monkeypox cases.
§§ Illness onset date refers to the earliest date available for each case. Dates
§ https://www.cdc.gov/poxvirus/monkeypox/response/2022/vaccines_data.html
¶ Cases reflect infections occurring among persons who self-reported sex assigned available for selection varied by how the case was reported to the system and
at birth or self-reported gender identity as male. include illness onset, specimen collection, lab test completion, admission,
diagnosis, discharge, case investigation start date, or date first electronically
submitted or reported to the county, state, or public health department.
¶¶ Receipt of ≥1 dose of JYNNEOS vaccine.

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 Morbidity and Mortality Weekly Report

as 1) unvaccinated; 2) potentially vaccinated, without date of persons; a 95% CI for the average IRR was calculated to
vaccination; 3) vaccinated, with illness onset ≤13 days after their account for variation in weekly rates. Weighting was based on
first dose; or 4) vaccinated, with illness onset ≥14 days after their the population size in each vaccination status category.
first dose.*** Two sensitivity analyses were conducted. The first examined
Vaccination coverage was estimated as the total number of changes in IRR when considering the total estimated MSM
persons vaccinated as of 2 weeks before the start date of a week, population as eligible for vaccination. The second examined
divided by the estimated population eligible for vaccination.††† changes in IRR under the assumptions that 50% or 100%
This underlying population included persons in each jurisdic- of persons with monkeypox with unknown vaccination date
tion who might benefit from expanded vaccination in the con- received vaccine ≥14 days before illness onset. SAS (version 9.4;
text of the outbreak and was estimated as the number of MSM SAS Institute) and R (version 4.0.3; R Foundation) were used
with HIV or who are eligible for HIV preexposure prophylaxis to conduct all analyses. This activity was reviewed by CDC
(HIV-PrEP) (6). The number of eligible unvaccinated persons and was conducted consistent with applicable federal law and
was obtained by subtracting the number of vaccinated persons CDC policy.****
from estimates of the vaccine-eligible population. Weekly§§§ During July 31–September 3, 2022, among 32 jurisdictions
incidence by vaccination status was calculated as the number reporting 6,471 monkeypox cases (range across jurisdictions =
of cases divided by the number of persons either unvaccinated 2–2,186 cases), a total of 5,402 (83.5%) were reported among
as of that week or vaccinated as of 2 weeks earlier.¶¶¶ Because males aged 18–49 years (Table). Among these, a total of 4,606
relatively few persons had received a second vaccine dose within (85.3%) cases were among unvaccinated persons, 269 (5.0%)
the time frame of this analysis, incidence among persons who were among persons whose illness onset occurred ≤13 days
had received their first JYNNEOS vaccine dose ≥14 days earlier after receipt of their first vaccine dose, 77 (1.4%) were among
is reported. Persons with illness onset ≤13 days after receipt persons with illness onset ≥14 days after receipt of their first
of their first dose of vaccine, potentially vaccinated persons vaccine dose, and 450 (8.3%) were among persons without a
(those without a documented date of vaccination), and persons known vaccination date. No persons vaccinated before 2022
vaccinated before 2022 were excluded from the analysis. The were identified. Population coverage with 1 vaccine dose as
average incidence rate ratio (IRR) during the study period was of 2 weeks before the start of each week increased from 5.2%
calculated by dividing the weighted average incidence across all (July 31) to 29.9% (August 28) in the 32 jurisdictions; coverage
weeks among unvaccinated persons by that among vaccinated with two vaccine doses increased from 0.1% to 1.9%. As of
September 23, 2022, 10 and 2 cases had been reported in per-
*** Unvaccinated: No evidence in case record of receipt of JYNNEOS vaccine or sons who had received a second JYNNEOS vaccine ≤13 days
vaccination date after illness onset, including records for which vaccination
information was unknown. Potentially vaccinated: case record reflected some and ≥14 days before illness onset, respectively.
indication of vaccination, but without dose number or date. Vaccinated, illness Weekly monkeypox incidence during July 31–September 3
onset ≤13 days after first dose: illness onset ≤13 days of receiving first dose of was higher among unvaccinated persons than among those who
JYNNEOS vaccine. Vaccinated, illness onset ≥14 days after first dose: illness
onset ≥14 days after receiving first dose of JYNNEOS vaccine, excluding had received their first JYNNEOS vaccine dose ≥14 days earlier
persons vaccinated for smallpox before 2022. (Figure). Average IRR comparing unvaccinated persons with
††† The population aged 18–49 years that might benefit from expanded vaccination
includes MSM with HIV infection (jurisdiction-specific estimates of 2020
those who received 1 dose of vaccine ≥14 days earlier was 14.3
HIV prevalence are from CDC’s Atlas Plus [https://www.cdc.gov/nchhstp/ (95% CI = 5.0–41.0). A sensitivity analysis expanding the esti-
atlas/index.htm] describing MSM who acquired HIV through male-to-male mated number of persons eligible for vaccination yielded similar
sexual contact or male-to-male sexual contact and injection drug use) or who
are eligible for HIV-PrEP (estimated as the ratio of the jurisdiction-specific trends but lower average IRR (Supplementary Figure, https://
number of MSM receiving HIV preexposure prophylaxis (HIV-PrEP) and the stacks.cdc.gov/view/cdc/121578). A sensitivity analysis examin-
jurisdiction-specific HIV-PrEP coverage. The number of MSM with HIV or ing changes to IRR assuming 50% or 100% of persons with
who are eligible for HIV-PrEP aged 18–49 years was estimated by aggregating
2021 U.S. Census Bureau estimates for males aged 0–12, 13–17, 18–49, and unknown vaccination date received their vaccine dose ≥14 days
≥50 years, calculating the state proportion in each age group, and multiplying before illness onset yielded similar trends but lower average IRR
by the estimated number of MSM with HIV or who are eligible for HIV-PrEP
in each state to obtain proportional distributions. Additional details about
(Supplementary Table, https://stacks.cdc.gov/view/cdc/121579).
these methods can be obtained by contacting the corresponding author.
§§§ Cases and vaccine doses administered were aggregated by MMWR week. Discussion
Weeks begin on Sunday and end on Saturday.
¶¶¶ Because most vaccine administered during the study period was PEP, this Among 32 U.S. jurisdictions, monkeypox incidence among
time point was chosen to account for the incubation period after exposure. persons who were currently recommended to receive PEP or
Further, immunogenicity data submitted to FDA indicated that antibody
titers 2 weeks after the first dose were similar to titers 4 weeks after the first **** 5 C.F.R. part 46, 21 C.F.R. part 56; 42 U.S.C. Sect. 241(d); 5 U.S.C. Sect.
dose and were significantly higher than prevaccination antibody titers. 552a; 44 U.S.C. Sect. 3501 et seq.

US Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / October 7, 2022 / Vol. 71 / No. 40 1279
 Morbidity and Mortality Weekly Report

expanded PEP with JYNNEOS vaccine was higher among established. Second, this analysis was unable to control for
unvaccinated persons compared with those who had received possible differences in testing or behaviors that increase risk
their first vaccine dose ≥14 days earlier. Data for this analysis for MPXV exposure or possible differences in risk because
were collected during a period when vaccine was widely avail- of patient characteristics (e.g., age and underlying medical
able, reducing potential bias from limited vaccine accessibility. conditions, including HIV status); consequently, causality
Findings are consistent with recent studies reporting that a and a full attribution of these results to vaccination cannot
single dose of JYNNEOS vaccine for prevention of MPXV be inferred from these data. Third, incidence among persons
infection in males aged 18–42 years who were prescribed who received 2 JYNNEOS vaccine doses could not be assessed,
HIV-PrEP or with diagnosed HIV infection and one or more because of low second dose coverage and sparse data during
other sexually transmitted infection might provide some the study period precluded these estimates. Fourth, temporal-
protection (7) and modest induction of antibody levels after ity of exposures causing infection are not known. Vaccination
a single dose (8). strategies focused on PEP and expanded PEP during the study
The findings in this report are subject to at least six limita- period; however, some patients might have received vaccine
tions. First, linkage of monkeypox case surveillance and vac- before exposure, or might have had additional exposures after
cination administration data might result in misclassifications vaccination. Fifth, confirmation that all identified persons
that could influence IRR estimates. Some patients might not be with monkeypox were members of the population eligible for
linkable within a jurisdiction’s immunization registry because vaccination was not possible. Finally, data assessed from 32
of receipt of vaccine outside the jurisdiction, or interviewed jurisdictions accounted for 56% of the U.S. population eligible
persons with monkeypox might have incorrectly reported for vaccination and might not be generalizable.
their own vaccination status. This approach assumes that These data are intended to provide an early indication of
persons with unknown vaccination status were unvaccinated the real-world impact of vaccination with JYNNEOS for
and excludes those with unknown date of vaccination because preventing monkeypox and to guide public health prevention
timing between vaccination and illness onset could not be interventions (e.g., vaccinating persons at high risk for infection

TABLE. JYNNEOS vaccination coverage among males* aged 18–49 years and monkeypox cases by first-dose vaccination status† — 32 U.S.
jurisdictions,§,¶ July 31–September 3, 2022
No. (%), by week beginning
Characteristic Jul 31 Aug 7 Aug 14 Aug 21 Aug 28 Total
1-dose vaccination coverage, %** 5.2 9.8 16.2 23.9 29.9 NA
2-dose vaccination coverage,%†† 0.1 0.2 0.3 0.8 1.9 NA
Total monkeypox cases§§ 1,284 1,313 1,034 1,013 758 5,402

Vaccination status
Unvaccinated 1,097 (85.4) 1,103 (84.0) 872 (84.3) 881 (87.0) 653 (86.1) 4,606 (85.3)
Vaccinated 187 (14.6) 210 (16.0) 162 (15.7) 132 (13.0) 105 (13.9) 796 (14.7)
Vaccination date known
No 121 (9.4) 118 (9.0) 79 (7.6) 78 (7.7) 54 (7.1) 450 (8.3)
Yes 66 (5.1) 92 (7.0) 83 (8.0) 54 (5.3) 51 (6.7) 346 (6.4)
Illness onset relative to vaccination (among those with known vaccination date)
0–13 days after first dose 62 (4.8) 73 (5.6) 65 (6.3) 39 (3.8) 30 (4.0) 269 (5.0)
≥14 days after first dose 4 (0.3) 19 (1.4) 18 (1.7) 15 (1.5) 21 (2.8) 77 (1.4)
Before second dose 4 (0.3) 17 (1.3) 16 (1.5) 11 (1.1) 17 (2.2) 65 (1.2)
0–13 days after second dose 0 (—) 2 (0.2) 1 (0.1) 4 (0.4) 3 (0.4) 10 (0.2)
≥14 days after second dose 0 (—) 0 (—) 1 (0.1) 0 (—) 1 (0.1) 2 (0.1)
Abbreviations: NA = not applicable; PCR = polymerase chain reaction.
* Defined as sex assigned at birth or gender identity.
† Vaccinated: persons who had received ≥ 1 dose of JYNNEOS vaccine.
§ Alaska, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana,
Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia,
West Virginia, and Wisconsin.
¶ Jurisdictions were included if age and sex assigned at birth or gender identity were available for ≥70% of cases reported, vaccination status was available for ≥50%
of cases in males (defined by either sex assigned at birth or gender identity) aged 18–49 years or the jurisdiction confirmed that cases are linked to immunization
registry entries, and de-identified vaccination administration data were submitted to CDC.
** Proportion of population eligible for vaccination that had received 1 dose of JYNNEOS vaccine as of 2 weeks before the start of the week.
†† Proportion of population eligible for vaccination that had received 2 doses of JYNNEOS vaccine as of 2 weeks before the start of the week.
§§ Confirmed (presence of Monkeypox virus DNA by PCR testing or Next-Generation sequencing of a clinical specimen or isolation of Monkeypox virus in culture from
a clinical specimen) and probable (presence of Orthopoxvirus DNA by PCR testing, or Orthopoxvirus using immunohistochemical or electron microscopy or detectable
levels of anti-Orthopoxvirus immunoglobulin M antibody) monkeypox cases.

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 Morbidity and Mortality Weekly Report

FIGURE. Weekly monkeypox incidence,* by first-dose vaccination status†,§ among males aged 18–49 years eligible for vaccination¶ — 32 U.S.
jurisdictions**, †† July 31–September 3, 2022

350

300

250
Monkeypox incidence

Unvaccinated
200 Vaccinated

150

100

50

0
Jul 31 Aug 7 Aug 14 Aug 21 Aug 28

MMWR week beginning

Abbreviation: IRR = incidence rate ratio.

* Cases per 100,000 population. Rate in vaccinated persons = number of probable or confirmed cases reported to CDC with date of illness onset, specimen collection,
lab test completion, admission, diagnosis, discharge, case investigation start date, or date first electronically submitted or reported to the county, state, or public
health department (earliest available date) ≥14 days after receiving the first dose of JYNNEOS vaccine among total vaccinated population as of 2 weeks previously.
Rate in unvaccinated persons = number of probable or confirmed cases reported to CDC without evidence of vaccination among total unvaccinated population.
† Vaccinated = persons who had received ≥1 dose of JYNNEOS ≥14 days earlier.
§ Average IRR comparing unvaccinated persons with those who received 1 dose of vaccine ≥14 days earlier was 14.3.
¶ Gay, bisexual, and other men who have sex with men who have HIV infection or who are eligible to receive HIV preexposure prophylaxis were considered eligible
for vaccination.
** Alaska, California, Colorado, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana,
Nevada, New Hampshire, New Mexico, North Dakota, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Virginia,
West Virginia, and Wisconsin.
†† Jurisdictions were included if age and sex assigned at birth or gender identity was available for ≥70% of cases reported, vaccination status was available for ≥50%
of cases in males (defined by either sex assigned at birth or gender identity) aged 18–49 years or the jurisdiction confirmed cases were linked to immunization
registry entries, and de-identified vaccination administration data were submitted to CDC.

while still encouraging harm reduction strategies, including

reducing the number of sexual partners and one-time sexual Summary
encounters) (9). The framework used in this analysis allows What is already known about this topic?
for ongoing comparison of observed IRRs over time and can Real-world monkeypox vaccine performance data are limited in
be used to monitor vaccine performance after a second dose. the context of the ongoing monkeypox outbreak.
Durability of immunity after a single dose is not yet known, What is added by this report?
and because vaccine effectiveness and duration of protection are Across 32 U.S. jurisdictions, among males aged 18–49 years
anticipated to be better after 2 doses, it remains important that eligible for JYNNEOS vaccination, monkeypox incidence was
all vaccinated persons receive their second dose. Monitoring 14 times as high among unvaccinated males compared with
monkeypox incidence by vaccination status using currently those who had received a first vaccine dose ≥14 days earlier.
available surveillance data might provide early estimates of What are the implications for public health practice?
vaccine performance for rapid public health decision making. These early findings suggest that a single JYNNEOS dose
Although the findings are encouraging, corroboration and provides some protection against monkeypox infection. The
degree and durability of such protection is unknown, and it is
confirmation through planned epidemiologic studies that are
recommended that persons who are eligible for monkeypox
better able to account for potential biases are needed. This vaccination receive the complete 2-dose series.

US Department of Health and Human Services/Centers for Disease Control and Prevention MMWR / October 7, 2022 / Vol. 71 / No. 40 1281
 Morbidity and Mortality Weekly Report

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