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National Center for Emerging and Zoonotic Infectious Diseases
Updates from the 2022 –2023 U.S. Mpox Outbreak:
Epidemiology, Vaccine Safety, and Vaccine
Effectiveness
ACIP Meeting
June 23, 2023Faisal Syed Minhaj, PharmD, MPH, DABAT
Epidemic Intelligence Service Officer
Poxvirus and Rabies Branch
United States Mpox Case Counts April 2022 –June 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
United States Mpox Case Counts January 1 –June 6, 2023
Uptick in
cases in
Chicago
https://www.cdc.gov/poxvirus/mpox/response/2022/mpx -trends.html
Mpox cases reported to CDC by age and gender May
2022 –June 14, 2023
https://www.cdc.gov/poxvirus/mpox/response/2022/demographics.htmlData were available for 98.9% of cases
reported to CDC
Mpox cases reported to CDC by race and ethnicity May
2022 –June 14, 2023
56 1050 8859 11782 5289 1894 753 340 196 64 71 42 81 10 Count within columns
https://www.cdc.gov/poxvirus/mpox/response/2022/demographics.htmlSubject to reporting
irregularities
Data were available for 93.7%
of cases reported to CDC
Chicago Mpox Cases
Increases in mpox
cases detected
https://www.chicago.gov/city/en/sites/monkeypox/home/data.html
Cluster of cases in Chicago
▪From March 18 –June 12, Chicago identified 40 laboratory confirmed mpox
cases
–All males with a median age of 36 years (IQR 23 –49)
–22 (55%) were vaccinated with 2 doses of JYNNEOS or 1 -dose of ACAM2000
–5 (13%) were partially vaccinated (i.e., 1 dose JYNNEOS)
–13 (33%) were unvaccinated
▪11 were living with HIV
–10 were vaccinated with 2 doses of JYNNEOS or 1 dose of ACAM2000 had
well controlled HIV
▪Median time from 2nddose of JYNNEOS to mpox diagnosis was 8.4 months (IQR
7.9–8.8 months)
https://www.cdc.gov/mmwr/volumes/72/wr/mm7225a6.htm
Cluster of cases in Chicago
▪Individuals with 2 doses of JYNNEOS or 1 dose of ACAM2000 had self -limiting
illness
–Lower prevalence of mucosal lesions
–None were hospitalized
▪Individuals with 2 doses of JYNNEOS or 1 dose of ACAM2000 had a higher
number of sexual partners 3 weeks before symptom onset compared to
partially or unvaccinated
▪Preliminary sequencing indicates the virus is the same B.1 variant of Clade IIB
which is the predominant variant of the 2022 –2023 outbreak
–There were no mutations that would confer increased pathogenicity
▪This investigation is ongoing, however no similar clusters are being seen
elsewhere in the U.S.
https://www.cdc.gov/mmwr/volumes/72/wr/mm7225a6.htm
Epidemiology of Mpox in Less Affected
Populations
Mpox in Pregnant People in the U.S.
▪From May 11, 2022 –May 31, 2023, 27 cases of mpox reported to CDC
occurred in pregnant people
▪All exposure were through close contact with a person with confirmed
infection (including sexual or household contact)
▪Infections occurred in all trimesters of pregnancy
▪11 (40.7%) received tecovirimat without adverse events reported
▪Outcomes
–3 (11.1%) pregnancy losses at <20 weeks
–6 (22.2%) live births
–18 (66.7%) pregnancies ongoing
Neonatal Transmission and Breastfeeding
Considerations
▪Of 6 live births, two neonates developed lesions within one week after
their mothers became symptomatic.
–Both neonates received oral tecovirimat; one received VIGIV.
–Both neonates responded to treatment and were discharged home.
–One breastfeeding neonate developed face and chest lesions 6 days
after the mother developed breast lesions.
▪One woman with isolated ocular lesions continued to breastfeed her 2 -
year -old infant without transmission
–Breastmilk tested on two separate occasions was MPXV PCR negative
VIGIV: vaccinia immune globulin intravenous
Mpox in a U.S. Neonate
▪12 hours after vaginal delivery, it was learned
that dad had active mpox and had contact with
mom prior to delivery
▪Mom developed lesions 1 day after delivery on
the abdomen and tested positive for mpox
▪Baby was given VIGIV as post -exposure
prophylaxis
▪At 4 days old, baby developed scalp lesions and
tested negative for HSV, positive for mpox
▪Baby was given tecovirimat and discharged at 17
days old
▪Full resolution 4 weeks after discharge
Scalp
lesion,
4 days old
Scalp
lesion,
13days
old
Nowalk A, Dunmore E (unpublished) VIGIV: vaccinia immune globulin intravenous
Mpox in a neonate in the United Kingdom
•Nine days before birth, dad developed a
febrile illness, followed by a rash that
resolved prior to the baby’s birth
•Four days after birth, a similar rash
appeared on mom
•Nine days after birth, the infant also
developed a similar rash and diagnosed
with both mpox and adenovirus
•Treated with 14 days of enteral
tecovirimat and intravenous cidofovir
•Critically ill, requiring 4 weeks in ICU and
14 days on mechanical ventilation before
discharged home
Ramnarayan P , Mitting R, N Engl J Med . 2022 Oct 27;387(17):1618 -1620.
Epidemiologic Characteristics of Pediatric Cases in the
U.S., May 17 –September 24, 2022
Characteristic% by age group, yrs
0–4 5–12 13–17
(n = 16) (n = 12) (n = 55)
Sex
Male 75% 50% 89%
Female 25% 50% 11%
Race or ethnicity
Black, non -Hispanic 44% 42% 49%
Hispanic or Latino 31% 42% 34%
White, non -Hispanic 19% 17% 9%
Asian, non -Hispanic — — 4%
American Indian or Alaska Native, non -Hispanic — — 2%
Native Hawaiian or other Pacific Islander, non -Hispanic 6% — —
Other, non -Hispanic — — 2%
Exposure setting and route
Sexual contact — — 97%
Household contact 93% 100% —
Other 7% — 3%
•<1% of U.S. cases among persons <18 years of age
•Among adolescents, cases predominantly after male -to-male sexual
contact
•Among younger children, predominantly household contact
Hennessee I. MMWR Morb Mortal Wkly Rep 2022;71:1407 –1411.
MPXV Infections Among
Children Aged ≤12 Years —
U.S., September 25 –
December 31, 2022
▪Mpox cases in children ≤12
years are rare
▪Transmission to children is
primarily from mpox positive
caregiver interactions
Nemechek K, MMWR Morb Mortal Wkly Rep 2023;72:633 –635.
Healthcare Personnel (HCP) Infections Reported to
CDC
▪During investigation of cases where HCP was noted within a case report
form, the exposure was often outside the workplace
▪After excluding all other more likely exposures, only 23 (0.08%) cases
potentially involved HCP exposed at work
▪HCP infections are very rare
Healthcare Personnel Cases That Consulted CDC (n=6)
▪Three were sharps injuries while trying to aspirate/unroof lesions
–CDC has since revised its recommendations to discourage unroofing
lesions
–Globally, this constitutes the majority of HCP infections
▪Two cases among HCP where improper personal protective equipment was
worn
▪One case where the exposure route was unclear
Vaccine: Coverage, Safety and Effectiveness
First and Second Doses of JYNNEOS Vaccine
Administrations−United States, May, 2022 to May 2023
Overall vaccine coverage
1-dose: 36.7% and 2-dose: 22.7%
Risk for recurrent mpox outbreak lasting >3 months,
by immunity level —United States, 2023
Pollock ED . MMWR Morb Mortal Wkly Rep 2023;72:568 –573.
Cumulative Monkeypox virus infections relative to
2022, by immunity level —United States, 2023
Pollock ED . MMWR Morb Mortal Wkly Rep 2023;72:568 –573.
Cumulative Monkeypox virus infections relative to
2022, by immunity level —United States, 2023
Pollock ED . MMWR Morb Mortal Wkly Rep 2023;72:568 –573.>50% is needed
to significantly
decrease the risk
of large outbreaks
JYNNEOS Vaccine Safety Monitoring
▪CDC vaccine safety monitoring is ongoing using two surveillance systems:
–Vaccine Adverse Event Reporting System (VAERS)
–Vaccine Safety Datalink (VSD)
▪V-safe data collection for mpox vaccines was available from November
2022 through March 21, 2023
JYNNEOS Vaccine Safety Findings Summary
▪The adverse events most commonly reported to VAERS have been injection
site symptoms (redness, swelling, pain, itching)
▪Uncommon, but expected, adverse events that have been reported to
VAERS include:
–Syncope: 49 reports per million doses administered
–Anaphylaxis: 2 reports per million doses administered
▪Myocarditis and pericarditis are adverse events of special interest
–Observed rates are consistent with expected background rates
JYNNEOS Vaccine Safety Conclusions
▪VAERS and VSD data do not suggest an increased risk for myocarditis or
pericarditis following JYNNEOS, but the possibility of a small risk cannot be
excluded
▪The frequencies of local and systemic reactions reported to v -safe after
mpox vaccine were similar to those reported in clinical trials
▪No new or unexpected safety concerns have been identified
Epic Cosmos Study: Methods
▪Data Source: Epic’s electronic health record (EHR) platform, Cosmos, which includes
records from >173 million patients across the U.S.
▪Design: Case -control analysis, matched 1:4 based on week of index event, HHS region,
and gender identity
–Cases : Patients with anmpox diagnosis or positive orthopoxvirus or MPXV laboratory
result from 8/15 -11/19/2022
–Controls: Patients with an incident HIV diagnosis or HIV pre -exposure prophylaxis
(PrEP ) prescription from 8/15 -11/19/2022
▪Analysis:
–Vaccine effectiveness (VE) estimated using conditional logistic regression
–Adjusted for age, race/ethnicity, social vulnerability index, immunocompromising
conditions
–Stratified by route of administration and immunocompromised status
Epic Cosmos Case -Control Study: VE for 1-Dose and 2-
Dose JYNNEOS vaccination
https://www.nejm.org/doi/full/10.1056/NEJMoa2215201?query=featured_home*Adjusted for age, race/ethnicity, social vulnerability index, and immunocompromising conditions.
Cases/controls matched on week of index event, HHS region, gender identity.
Multi -jurisdictional Case -Control Study: Methods
▪Design: Case -control study
▪Population: Men who have sex with men; ages 18 -49; 12 U.S. jurisdictions
▪Methods:
–Cases identified from jurisdictions’ probable and confirmed mpox case
lists
–Controls identified from healthcare settings providing HIV PrEP or
sexually transmitted infection (STI) clinics
–Demographics, exposure history, and vaccination history collected using
electronic surveys
–Vaccination status confirmed by state immunization registries
–Analysis:
–VE estimated using conditional logistic regression
–Adjusted for age, race/ethnicity, immunocompromising conditions
–Stratified by route of administration and immunocompromised status
Multi -jurisdictional Case -Control Study Results: VE for
1-Dose and 2-Dose JYNNEOS vaccination
https://www.cdc.gov/mmwr/volumes/72/wr/mm7220a3.htm?s_cid=mm7220a3_w
Multi -jurisdictional Case -Control Study Results: VE for
1-Dose and 2-Dose JYNNEOS vaccination
https://www.cdc.gov/mmwr/volumes/72/wr/mm7220a3.htm?s_cid=mm7220a3_w
New York State Case -Control Study: Methods
▪Design: Case -control study
▪Data source: Linkage of case surveillance to immunization registry in New York
State, excluding New York City
▪Population: males at birth aged ≥18 years
▪Methods:
▪Cases : Adult male mpox cases during July 24 –October 31, 2022
▪Controls : Adult male STI cases (rectal gonorrhea or primary syphilis) during July
24 –October 31, 2022
▪Vaccination status obtained from immunization registries
▪Analysis: Conditional logistic regression model adjusted for week of diagnosis,
race, age, region within state
New York State Case -Control Study Results: VE for 1-
Dose and 2-Dose JYNNEOS vaccination
*Adjusted for age, race/ethnicity, week of diagnosis, and geographic region
https://www.cdc.gov/mmwr/volumes/72/wr/mm7220a4.htm
VE against mpox ranges from 36% –75% for 1-Dose and
66% –89% for 2 -Dose JYNNEOS vaccination
Vaccine effectiveness of JYNNEOS against mpox
▪JYNNEOS vaccine is effective at reducing risk of mpox disease
▪Protection provided by both 1 and 2 doses of JYNNEOS vaccine
▪Highest protection provided by 2 doses, regardless of route of
administration
▪Further research needed to evaluate whether immunocompromised status
modulates VE
▪Further research needed to understand the duration of protection
Acknowledgements
▪Sarah Guagliardo
▪Andrea McCollum
▪Agam Rao
▪Omoshalewa Bamkole
▪David Yankey
▪Rosalind Carter
▪Romeo Galang
▪Amanda Cohn
▪Ian Kracalik▪Taina Joseph
▪Anne Kimball
▪Allie Tuttle
▪Marie de Perio
▪David Kuhar
▪Jonathan Duffy
▪Emily Faherty
▪Ian Spicknall
▪Chris Braden▪Varsha Neelam
▪Andrew Nowalk
▪Elizabeth Dunmore
▪Shama Cash -Goldwasser
▪Mukesh Hamal
▪Marisa Hast
▪Rebecca Free
▪Jim Matthias