06 COVID Oliver 508

cdc.gov/coronavirus
Updates to COVID -19 vaccine policy :
Considerations for Future Planning
Sara Oliver, MD, MSPH
ACIP Meeting
April 19, 2023
U.S. COVID -19 vaccine uptake among ages ≥12 years,
August 2021 -January 2023
Source: IZ Data Lake 01,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,000
Primary Series, Ages 12-17 Primary Series, Adults Ages 18-49 Primary Series, Adults Ages 50-64 Primary Series,  Adults Ages 65+
Booster, Ages 12-17 Booster, Adults Ages 18-49 Booster, Adults Ages 50-64 Booster Adults Ages 65+Primary series authorization
1stbooster authorization
2ndbooster authorization Bivalent booster authorization Doses Administered
Coverage / Age (years) <2 2–4 5–1112–1718–2424–4950–64>65
At least 1 -dose† 8.6 10.7 39.9 72.1 82.2 85.4 95.0 95.0
Completed primary series 4.5 5.9 32.8 61.7 66.7 72.1 83.8 94.3
Bivalent booster 0.5 0.5 4.6 7.6 7.2 11.8 21.4 42.4
Unvaccinated 91.4 89.3 60.1 28.1 17.8 14.6 —†—†U.S. COVID -19 Vaccination Coverage (%) of Total Population by
Age Group —April 13, 2023
†Note: Coverage is capped at 95%
Source: https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends Updated April 13 , 2023 3
PI=Prediction Interval, VOC=Variants of Concern, VBM=Variants Being Monitored . https://covid.cdc.gov/covid -data-tracker/#variant -proportions Accessed April 18, 2023Trends in weighted variant proportion estimates & Nowcast
United States, November 6, 2022 –April 15, 2023
Collection date, week ending
Estimated Number of Reported COVID -19 Cases by Variant
Variant Proportions Scaled by Positive Nucleic Acid Amplification Test (NAAT) Counts
CDC COVID -19 Lab Coordinating Unit Strain Surveillance and Emerging Variant Group. Data sources: https://covid.cdc.gov/covid -data-tracker/#variant -proportions and
https://covid.cdc.gov/covid -data-tracker/#trends_newtestresultsreported_7daytestingpositive_006M
04M
2MPositive tests / Proportion of viral lineages

Weekly population -based rates of COVID -19-associated hospitalizations
by age group —COVID -NET, March 2020 –April 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks.
https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalization -network Accessed April 13, 2023
Age Group
Updates to COVID -19 vaccine policy
COVID -19 vaccines:
Where we are now COVID -19 vaccines:
Where we are going  Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (possibly annual) dose for most individuals
Flexibility for vulnerable populations
Goal :
Simple
recommendations

Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (annual?) dose for most individuals
Flexibility for vulnerable populations

Single formulation for mRNA COVID -19 vaccines
▪Many monovalent COVID -19 vaccine products have already expired, others will
expire soon
▪With recent update, FDA removed authorizations for monovalent mRNA COVID -19
vaccine products
▪Harmonization across recommendations with bivalent mRNA COVID -19 vaccines was
discussed at VRBPAC in January and at ACIP meeting in February
Single formulation for mRNA COVID -19 vaccines
Benefits and Harms: Summary from previous ACIP meetings
10▪Bivalent COVID -19 vaccines are able to induce an immune response when given
either as a primary series or a booster dose
–Immunogenicity data showed that a BA.1 bivalent vaccine given as a primary series induced antibody
titers to BA.1 that were 25 times higher than the original monovalent vaccine
–Percentage of patients reporting solicited local or systemic events was similar to or less than percentages
seen after original vaccine, however this may be a result of the larger percent of seropositive participants
in the bivalent vaccine group
▪Limited data to directly compare COVID -19 outcomes after receipt of a monovalent or
bivalent vaccine
–Most studies show improvement in neutralizing antibodies for Omicron variants with a bivalent vaccine
–Bivalent vaccines expanded the immune response and provided increased diversity in antibody response
–While unable to directly compare clinical outcomes for monovalent and bivalent vaccines in the U.S., a
study in the UK found ~ 10% increase in VE for COVID -19 infections
Number of mRNA COVID -19 vaccine products
Moderna: 5 products
Pfizer -BioNTech: 6 products
Previously:
11 TOTAL Products!
Moderna: 2 products
Pfizer -BioNTech: 3 products
Moving forward:
5 Products
Eliminates look -alike vials for
Moderna and Pfizer -BioNTech
Single formulation for mRNA COVID -19 vaccines
Summary from February ACIP meeting
12▪Receiving COVID -19 vaccines continues to be important for prevention of COVID -19
severe disease, hospitalization, and death
▪Many children and adolescents remain unvaccinated for COVID -19
▪COVID -19 vaccine recommendations that are simple to implement may remove some
barriers to uptake
▪Harmonizing the formulation for mRNA COVID -19 vaccines could simplify the
presentations, reduce administration errors, and allow continued access to vaccines
▪ACIP was supportive of a transition of the mRNA COVID -19 vaccine primary series from
monovalent (original) to bivalent (original plus Omicron BA.4/5)
Single formulation for mRNA COVID -19 vaccines
Updates from FDA authorizations
13▪FDA removed the authorizations for monovalent mRNA COVID -19 vaccines
–BLAs are still in place for monovalent products:
•Comirnaty for ages 12 years and older, with limited doses in circulation
•Spikevax for ages 18 years and older, but all doses are currently expired
▪Bivalent mRNA COVID -19 vaccines are now authorized for all indications
▪No changes to current language in other COVID -19 vaccine authorizations
(Novavax or Janssen COVID -19 vaccines)
Single formulation for mRNA COVID -19 vaccines
Implications for CDC recommendations
14▪Transition to bivalent COVID -19 vaccines could simplify the presentations, reduce
administration errors, and allow continued access to vaccines with expiration of
monovalent products
Bivalent mRNA COVID -19 vaccines would now be recommended for all indications
Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (annual?) dose for most individuals
Flexibility for vulnerable populations

Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-
2 among people aged ≥16 years —United States, Quarter 2 2021 –Quarter 3 2022
No infection or vaccination
Vaccine only -induced
antibodies
Infection only -induced
antibodies
Both infection and
vaccination -induced
antibodies (hybrid immunity)
Source: CDC (unpublished)
Shifts in vaccine -induced, infection -induced, and hybrid immunity against SARS -CoV-
2 among people aged ≥16 years by age group —United States, Q2 2021 –Q3 2022
No infection or vaccination
Vaccination without previous
infection
Previous infection without
vaccination
Both previous infection and
vaccination (hybrid
immunity)
16–29 years 30–49 years
50–64 years ≥65 years
Source: CDC (unpublished)
How frequently should people get a COVID -19 vaccine?
▪Increases in COVID -19 cases (left) and hospitalizations (right) have occurred:
–During the winter months and/or
–Due to emergence of new immune escape variants
Cases from October 2021-February 2023 highlighted
Admissions from October 2021 –February 2023 highlighted
https://covid.cdc.gov/covid -data -tracker/#trends_weeklycases_select_00 https://covid.cdc.gov/covid -data -tracker/#new -hospital -admissions
Single (possibly annual) COVID -19 vaccine dose
Summary from February ACIP meeting
▪For most older children, adolescents, and adults, future doses will be additional ‘boost’
after prior infection, prior vaccination, or both
▪Time since last COVID -19 vaccine dose may both increase the incremental benefits of a
COVID -19 vaccine, and decrease the risk of myocarditis
▪Vaccine protection likely declines over time
▪Winter months and immune escape variants have impacted COVID -19 epidemiology
▪A simplified, annual recommendation could help reduce vaccine and message fatigue
▪A plan for a fall booster dose could provide added protection, at a time when many
would be ~1 year from last dose
–Future epidemiology and SARS -CoV-2 virus evolution could help determine the need for
continued annual boosters
Single (possibly annual) COVID -19 vaccine dose
Updates from FDA authorizations
20▪FDA authorized a single age -appropriate mRNA COVID -19 vaccine dose for most individuals
A single age-appropriate dose of a
bivalent Moderna COVID -19 vaccine
is authorized for individuals
ages 6 years and older
who are unvaccinated ,
or at least 2 months after receipt of any
monovalent COVID -19 vaccine. A single age -appropriate  dose of a
bivalent Pfizer COVID -19 vaccine
is authorized for individuals
ages 5 years and older
who are unvaccinated ,
or at least 2 months after receipt of any
monovalent COVID -19 vaccine

63828993
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
Month7585929799
0102030405060708090100
Mar-Apr May-Jun Jul-Aug Sep-Oct Nov-DecSeroprevalence (%)
MonthInfection-induced Combined (vaccine- and infection-induced)
Pediatric infection -induced and combined (vaccine -and infection -induced)
Seroprevalence from U.S. commercial laboratories —March –December 2022
Source: https://covid.cdc.gov/covid -data -tracker/#pediatric -seroprevalence and unpublished data (CDC) 21
COVID -19 vaccine recommendations in children 5 years and younger
▪Young children likely still need a ‘ prime ’ and ‘ boost ’ to optimize immunity
▪Young children will continue to age into the vaccine recommendations at 6 months and
could be SARS -CoV-2 naïve
▪Additional data forthcoming to evaluate benefits of a multi -dose primary series in all
children ages 5 years and younger, or if the recommendations could be simplified
–Cost effectiveness analysis
–Additional antibody data in young children
Coverage / Age (years) <2 years 2–4 years
At least 1 -dose 8.6 10.7
Completed primary series 4.5 5.9
Unvaccinated 91.4 89.3
Single (possibly annual) COVID -19 vaccine dose
Updates from FDA authorizations
23▪FDA authorized one, two, or three doses of a bivalent mRNA COVID -19 vaccine for
children 6 months –4 or 5 years
▪Number of doses depend on age, as well as number and type of prior COVID -19
vaccine doses received
Single (possibly annual) COVID -19 vaccine dose
Implications for CDC recommendations
24▪A COVID -19 vaccine framework for a single dose could be easy for COVID -19 vaccine
providers to implement, and for the public to understand
▪The current recommendations for a single dose may evolve over time, and could move
to an annual recommendation
A single bivalent dose would be recommended for everyone ages 6 years and older
–For most people, this is not a change: if someone has not received a bivalent vaccine dose
yet, they are recommended to receive one, regardless of their previous vaccine history
Children 6 months through 5 years would receive at least two COVID -19 vaccine doses,
including at least one bivalent COVID -19 vaccine
–Table and detailed guidance to be published in Interim Clinical Considerations

Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (annual?) dose for most individuals
Flexibility for vulnerable populations

Weekly population -based rates of COVID -19-associated hospitalizations
by age group —COVID -NET, March 2020 –April 2023
Gray boxes indicate potential reporting delays. Interpretation of trends should be excluded from these weeks.
https://covid.cdc.gov/covid -data -tracker/#covidnet -hospitalization -network Accessed April 13, 2023
Age Group
Rates of COVID -19 deaths by vaccination status and age, adults ≥65 years  —
24 U.S. Jurisdictions, April 2022 –January 2023
https://covid.cdc.gov/covid -data -tracker/#rates -by-vaccine -status Accessed April 14, 2023
Unvaccinated
Vaccinated without updated booster
Vaccinated with updated boosterUnvaccinated
Vaccinated without updated booster
Vaccinated with updated boosterAges 65 –79 yearsAges ≥80 years
▪In a January 2023 survey of adults who had previously received a bivalent booster:
–54% said they were awaiting new guidelines for additional doses
–86% said getting another booster shot was important or a top priorityAdditional updated COVID -19 vaccine doses
Survey data
The survey was conducted January 17 –January 24, 2023, online and by telephone among a nationally representative sample of 1,23 4 U.S. adults
KFF COVID -19 Vaccine Monitor: January 2023. https://www.kff.org/coronavirus -covid -19/poll -finding/kff -covid -19-vaccine -monitor -january -2023/
Accessed February 7, 2023
 28
COVID -19 vaccines and older adults (adults ages ≥65 years)
Summary from February ACIP meeting
▪Older adults have higher rates of hospitalization than younger adults
▪Among older adults, vaccination rates with a bivalent COVID -19 vaccine dose remain low
–It is important for older adults to be up to date on current recommendations, including
receiving a bivalent booster
▪ACIP discussed that data were insufficient to support a routine recommendation for
older adults to receive a COVID -19 vaccine doses every 6 months, but acknowledged this
population may continue to be more vulnerable to severe COVID -19 and likely needs
flexibility with COVID -19 vaccine recommendations
Flexibility for vulnerable populations
Updates from FDA authorizations
30▪For adults ages ≥65 years, a single dose of a bivalent mRNA COVID -19 vaccine (either
Moderna COVID -19 Vaccine or Pfizer -BioNTech COVID -19 vaccine) may be administered
at least 4 months following the first dose of a bivalent COVID -19 vaccine
Flexibility for vulnerable populations
Implications for CDC recommendations
31▪The bivalent COVID -19 vaccine continues to provide protection against severe COVID -19
disease, and rates of hospitalization or death among older adults who have received a
bivalent booster continue to be low
▪However, some older adults may benefit from an additional updated COVID -19 vaccine
dose prior to possible future recommendations for updated vaccines this fall
Adults ages 65 years and older may now choose to receive another
updated COVID -19 vaccine dose

COVID -19 vaccines and people who are immunocompromised
Summary from February ACIP meeting
▪Immunocompromised adults can have less robust immune response to COVID -19
vaccines
▪There are no currently authorized prophylactic monoclonal antibody products for
populations at highest risk of COVID -19
▪ACIP discussed that data were insufficient to support a routine recommendation for
people who are immunocompromised to receive a COVID -19 vaccine doses every 6
months, but acknowledged this population may continue to be more vulnerable to
severe COVID -19 and likely needs flexibility with COVID -19 vaccine recommendations
Flexibility for vulnerable populations
Updates from FDA authorizations
33▪For persons with moderate to severely immunocompromising conditions, a single dose
of a bivalent mRNA COVID -19 vaccine may be administered at least 2 months following
the first dose of a bivalent COVID -19 vaccine
▪Additional age -appropriate bivalent mRNA COVID -19 vaccine doses may be
administered to immunocompromised persons at the discretion of the healthcare
provider, taking into consideration the individual’s clinical circumstances
Flexibility for vulnerable populations
Implications for CDC recommendations
34▪For people who are immunocompromised, additional doses have been recommended
previously and current updates continue to allow additional protection to a vulnerable
population
▪Updates also allow flexibility to adjust to individual’s specific circumstances, including
timing of immunosuppression as well as the possible need for re -vaccination after
particular events (e.g. stem cell transplant)
–Additional guidance to be published in Interim Clinical Considerations
People who are immunocompromised may now choose to receive another updated
COVID -19 vaccine dose            -and-
Have the flexibility to receive additional doses based on their clinical circumstances

Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (possibly annual) dose for most individuals
Flexibility for vulnerable populations
Goal :
Simple
recommendations

Updates to COVID -19 vaccine policy
Steps toward simple recommendations :
Single formulation for mRNA COVID -19 vaccines
Single (possibly annual) dose for most individuals
Flexibility for vulnerable populations
Goal :
Simple
recommendations
Future a dditional steps may be possible :
Simplifications for all COVID -19 vaccines
Possible updated vaccines this fall
Continue to evaluate data -driven ways to
simplify pediatric program
Flexibility and simple guidance

▪COVID -19 vaccines continue to be the most effective tool we have to prevent serious
illness, hospitalization and death from COVID -19
▪Simple recommendations are easier to communicate, which may improve uptake
▪Anticipate that an updated fall vaccine could be available
▪Based on available data, anticipate benefits of COVID -19 vaccines given this fall
–Updates to COVID -19 vaccine policy can also acknowledge possible future recommendations
▪For most people, the current doses needed remain unchanged : a single bivalent vaccine
is recommended and there could be an updated vaccine/recommendation this fall
–Flexibility for vulnerable populations
–Young children continue to be recommended for multiple doses to prime/boost immune response,
and will continue to review additional dataUpdates to COVID -19 vaccine policy
Steps toward simple recommendations
▪Continue to review data and evaluate COVID -19 vaccine program in context of
evolving epidemiology
▪Early COVID -19 vaccine recommendations made in light of a highly susceptible,
immune naive population, with limited treatment options
▪Increases in population -level immunity through both vaccine and infection,
SARS -CoV-2 virus evolution, availability of anti -viral treatments, and review of COVID -
19 epidemiology and hospitalization rates can lead to evidence -based updates in
vaccine policy
▪Work is ongoing to review additional data, continue efforts for simplification
▪Work Group supportive of simplified recommendations as well as flexibility for
vulnerable populations Work Group interpretation
Steps toward simple recommendations
▪Monica Godfrey
▪Evelyn Twentyman
▪Danielle Moulia
▪Megan Wallace
▪Hannah Rosenblum
▪Lauren Roper
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Amadea Britton
▪Sarah Meyer
▪Julianne Gee
▪Susan Goldstein
▪Mary Chamberland
▪Elisha Hall▪Valerie Morelli
▪JoEllen Wolicki
▪Heather Scobie
▪Sierra Scarbrough
▪Jefferson Jones
▪Aron Hall
▪Barbara Mahon
▪Coronavirus and other Respiratory Viruses Division
▪National Center for Immunization and Respiratory
DiseasesAcknowledgments
Question for ACIP
40▪What are ACIP's thoughts on simplified recommendations as well as
flexibility for vulnerable populations?
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
Thank you

Summary: cdc.gov/coronavirus Updates to COVID -19 vaccine policy :  Considerations for Future Planning Sara Oliver, MD, MSPH ACIP Meeting April 19, 2023 U.S. COVID -19 vaccine uptake among ages ≥12 years,  August 2021 -January 2023 Source: IZ Data Lake 01,000,0002,000,0003,000,0004,000,0005,000,0006,000,0007,000,000 Primary Series, Ages 12-17 Primary Series, Adults Ages 18-49 Primary Series, Adults Ages 50-64 Primary Series,  Adults Ages 65+ Booster, Ages 12-17 Booster, Adults Ages 18-49 Booster,…


07 COVID Twentyman 508

Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
National Center for Immunization and Respiratory Diseases
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or any use by other CDC CIOs or any external audiences.Updates to Interim Clinical Considerations for
Use of COVID -19 Vaccines
Evelyn Twentyman, MD MPH
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
Overview of implications
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
Previous recommendations for people aged ≥6 years
without immunocompromise

New recommendations for people aged ≥6 years without
immunocompromise who have not yet received a bivalent
mRNA dose
One bivalent
mRNA dose
New recommendations for people aged  ≥6 years without immunocompromise who
have not yet received a bivalent mRNA dose , regardless of COVID -19 vaccination
history
One bivalent
mRNA dose≥1 monovalent
Moderna dose
≥1 monovalent
Novavax dose
≥1 monovalent
Janssen dose
No COVID -19
vaccine doses≥1 monovalent
Pfizer -BioNTech
dose
New recommendations for aged ≥6 years without
immunocompromise who have already received a bivalent
mRNA dose
One bivalent
mRNA dose
Vaccination is complete.
No doses are indicated at this time.
▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
Flexible for people at higher risk of severe COVID -19:
People aged ≥65 years who have not yet received a bivalent
mRNA dose
One bivalent
mRNA doseOptional additional
bivalent mRNA dose
At least
4 months
Flexible for people at higher risk of severe COVID -19:
People aged ≥65 years who have already received a bivalent
mRNA dose
One bivalent
mRNA doseOptional additional
bivalent mRNA dose
At least
4 months

New flexibility for people at higher risk of severe COVID -19:
People aged ≥6 years with immunocompromise* who have
already received a bivalent mRNA dose
*Including those with imminent immunocompromise (e.g., prior to organ transplant; other causes.)One bivalent
mRNA doseOptional additional
bivalent mRNA dose
At least
2monthsAdditional
bivalent mRNA
doses as needed
At least
2monthsStem cell transplant
CAR-T therapy
B-cell depletion
Others

▪Simple and singular for most
▪Flexible for people at higher risk
▪Customized recommendations for young childrenImplications of the new recommendations
Doses previously recommended:
Moderna:
•2monovalent primary series doses +
•1 bivalent booster dose
Pfizer:
•2or3monovalent primary series
doses +
•1 bivalent primary series doseTransitioning from the monovalent to the bivalent era for
children without immunocompromise aged 6 months –4 years
Doses now recommended:
Customized by COVID -19
vaccination history such that all
children receive:
•At least 2 vaccine doses in total
including
•At least 1 bivalent dose
Number of
doses
indicated, by
manufacturer
Vaccination complete.COVID -19 vaccination
status April 2023
Previously received vaccine(s)COVID -19 vaccination algorithm for people without immunocompromise, ages 6 months –4 years, mRNA vaccines April 2023*
Vaccinated Unvaccinated
1dose bivalent Moderna1dose
monovalent
Moderna2doses
monovalent
Moderna
2doses
bivalent
Pfizer -
BioNTech1dose
monovalent
Pfizer -
BioNTech2doses
monovalent
Pfizer -
BioNTech3doses
monovalent
Pfizer -
BioNTech
1dose bivalent Pfizer -
BioNTech2doses
monovalent
Moderna and 1
dose bivalent
Moderna2doses
monovalent
Pfizer -BioNTech
and 1dose
bivalent Pfizer -
BioNTech
*To see product -specific doses and intervals of administration, see Table 1 and 2 forthcoming in Interim Clinical Considerations , forthcoming.2doses
bivalent
ModernaOR3doses
bivalent
Pfizer -
BioNTech
Doses previously recommended:
Moderna:
•2monovalent primary series doses +
•1 bivalent booster dose
Pfizer:
•2or3monovalent primary series
doses +
•1 bivalent primary series doseTransitioning from the monovalent to the bivalent era for
children without immunocompromise aged 5 years
Doses now recommended:
Customized so that Moderna
recipients receive:
•At least 2 vaccine doses in total
including
•At least 1 bivalent dose
And Pfizer recipients receive:
•At least 1 bivalent dose
Vaccination complete.Number of
doses
Indicated, by
manufacturerPreviously received vaccine(s)COVID -19 vaccination
status April 2023 Vaccinated Unvaccinated
1 or more doses
monovalent
Moderna1 or more doses
monovalent
Pfizer -BioNTechAny doses
monovalent
Pfizer -BioNTech
and 1dose
bivalent Pfizer -
BioNTech2doses
monovalent
Moderna and 1
dose bivalent
mRNA
OR2doses
bivalent
Moderna1dose
bivalent
Pfizer -
BioNTech1dose
bivalent
Pfizer -
BioNTechCOVID -19 vaccination algorithm for people without immunocompromise, age 5 years, mRNA vaccines April 2023*
*To see product -specific doses and intervals of administration, see reference Table 1 in Interim Clinical Considerations, forthc oming1dose
bivalent
Moderna
▪Adults and children aged 6 years and older are up to date with COVID -19 vaccines if they got a bivalent
(updated) COVID -19 vaccine.
▪Children 6 months through 5 years of age who received the Pfizer -BioNTech COVID -19 vaccine are up to
date if:
–They are 6 months to 4 years of age and got at least 3 COVID -19 vaccine doses, including at least one
bivalent (updated) COVID -19 vaccine dose.
–They are 5 years of age and got at least 1 bivalent (updated) COVID -19 vaccine dose.
▪Children 6 months through 5 years of age who got the Moderna COVID -19 vaccine are up to date if they got
at least two Moderna COVID -19 vaccine doses, including at least one bivalent (updated) COVID -19 vaccine
dose.
▪You may be eligible for additional COVID -19 vaccine doses if:
–You are 65 years of age and older and got your first bivalent (updated) COVID -19 vaccine booster 4 or
more months ago.
–You are moderately or severely immunocompromised and received a bivalent (updated) COVID -19
vaccine booster 2 or more months ago.
▪If you are unable or choose not to get a recommended bivalent mRNA vaccine, you will be up to date if you
got the Novavax COVID -19 vaccine doses approved for your age group. Stay Up to Date with COVID -19 Vaccines
Implications for vaccine providers
Moderna
Pfizer -BioNTech
Novavax
JanssenFewer COVID -19 Vaccine Products in Use
Bivalent Bivalent
BivalentBivalent BivalentBivalent Bivalent
Bivalent Bivalent Bivalent
All remaining Janssen vaccine doses
expire by May 6th2023Manufacturer Products Previously in Use Products Now in Use
▪CDC’s Interim Clinical Considerations for Use of Authorized
COVID -19 Vaccines will be updated with comprehensive tables
of vaccine doses and dosages indicated
•For each age group
•By history of COVID -19 vaccines received, for children ages 6 months
through 5 years
▪Revision of clinical guidance materials is underway
▪COCA Call to be held May 11th, 2023*Additional help for providers is on the way
*Please visit https://emergency.cdc.gov/coca/ for complete details
Implications for public health
Bivalent COVID -19 vaccine coverage is low.
COVID -19 Data Tracker, last updated April 13, 2023, CDC COVID Data Tracker: Vaccinations in the US16.7% of the total U.S.
population has received a
bivalent COVID -19 vaccine.20.2% of adults aged
≥18 years in the U.S. have
received a bivalent COVID -
19 vaccine.
COVID -19 Data Tracker, last updated April 13, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trends43%22%12%7%8%5%
> 65 years50–64 years25–49 years18–24 years12–17 years5–11 years2–4 years<2 yearsBivalent COVID -19 Vaccination Coverage by AgeBivalent COVID -19 vaccine coverage generally decreases with
decreasing age.
COVID -19 Data Tracker, last updated April 14, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trendsBivalent COVID -19 vaccine c overage is lower among Black, non -
Hispanic, Hispanic/Latino , and Native Hawaiian or Other Pacific
Islander .
17%12%24%9%9%22%15%
White, NHNHOPI, NHMultiracial, NHHispanic/LatinoBlack, NHAsian, NHAI/AN, NHBivalent COVID -19 Vaccination Coverage by Race/Ethnicity
COVID -19 Data Tracker, last updated April 14, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trendsBivalent COVID -19 vaccine coverage is lower among those with lower
income.
39%29%27%
Above poverty,
income >$75KAbove poverty,
income <$75KBelow povertyBivalent COVID -19 vaccine coverage by income among adults aged ≥18 years
COVID -19 Data Tracker, last updated April 14, 2023, https://covid.cdc.gov/covid -data -tracker/#vaccination -demographics -trendsBivalent COVID -19 vaccine coverage is lower among those without
health insurance .
35%15%
With Health
InsuranceWithout
Health
InsuranceBivalent COVID -19 vaccine coverage among adults aged ≥18 years by insurance status
▪COVID -19 vaccines continue to be the most effective tool we have to prevent serious
illness, hospitalization and death from COVID -19
–Uptake of the updated (bivalent) COVID -19 vaccines is not yet equitable, and
remains generally low
▪Simple recommendations are easier to communicate, which may improve vaccine
uptake
▪CDC is continuing to work toward additional materials for vaccine providers,
clinicians and the general public to make it easy for everyone to get up to date and
stay up to date with COVID -19 vaccinesReflections and Next Steps
▪Sara Oliver
▪Hannah Rosenblum
▪Mary Chamberland
▪Susan Goldstein
▪Elisha Hall
▪JoEllen Wolicki
▪Katherine Fleming -Dutra
▪Ruth Link -Gelles
▪Monica Godfrey
▪Danielle Moulia
▪Megan Wallace
▪Lauren Roper
▪Amadea Britton
▪Sarah Meyer
▪Julianne Gee▪Heather Scobie
▪Sierra Scarbrough
▪Yvonne Bolen
▪Jefferson Jones
▪Noelle Molinari
▪Aron Hall
▪Barbara Mahon
▪Data Analytics and Visualization Task Force
▪Coronavirus and other Respiratory Viruses
Division
▪Immunization Services Division
▪National Center for Immunization and Respiratory
DiseasesAcknowledgments
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY:  1 -888-232-6348    www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position o f the Centers for Disease Control and Prevention.
Photographs and images included in this presentation are licensed solely for CDC/NCIRD online and presentation use. No rights are implied or extended for use in printing or
any use by other CDC CIOs or any external audiences.
Additional Flowcharts
Vaccination complete. Optional additional doses as needed**Previously received vaccine(s)
Number of
doses
Indicated, by
manufacturer COVID -19 vaccination
status April 2023
1 or more
doses
monovalent
Moderna2dose
monovalent
Pfizer -BioNTech
and 1dose
bivalent mRNA2doses
monovalent
Moderna and 1
dose bivalent
mRNA
1dose bivalent Moderna
1dose bivalent Pfizer -BioNTechOR1 or more
doses
monovalent
Pfizer -
BioNTechVaccinated UnvaccinatedCOVID -19 vaccination algorithm for people who are NOT moderately or severely immunocompromised, age 6 years and older, mRNA vacc ines April 2023*
*To see product -specific doses and intervals of administration, see reference Table 1 in Interim Clinical Considerations, forthcoming.
**People ages 65+ have the option to receive 1 additional bivalent mRNA dose at least 4 months after the first dose of a biva lent mRNA vaccine.
Tables
COVID -19 vaccination history Bivalent vaccine Number of bivalent
doses indicatedDosage (mL/ug) Vaccine vial cap and label colors Interval between doses
UnvaccinatedModerna
___or___20.25 mL/25 ug Dark blue cap; gray label borderDose 1 and Dose 2:
4–8 weeks
Pfizer BioNTech30.2 mL/3 ug MaroonDose 1 and Dose 2:
3–8 weeks
Dose 2 and dose 3:
At least 8 weeks
1 dose monovalent Moderna Moderna 1 0.25 mL/25 ug Dark blue cap; gray label border 4-8 weeks after monovalent dose
2 doses monovalent Moderna Moderna 1 0.2 mL/10 ug Dark pink cap; yellow label border At least 8 weeks after last monovalent dose
2 doses monovalent Moderna
and 1 dose bivalent Moderna NA; previously received 1
bivalent vaccine dose NA NA NA NA
1 dose monovalent Pfizer -
BioNTechPfizer BioNTech 2 0.2 mL/3 ug MaroonDose 1: 3 –8 weeks after monovalent dose
Dose 1 and Dose 2: At least 8 weeks
2 doses monovalent Pfizer -
BioNTechPfizer BioNTech 1 0.2 mL/3 ug Maroon At least 8 weeks after last monovalent dose
3 doses monovalent Pfizer -
BioNTechPfizer BioNTech 1 0.2 mL/3 ug Maroon At least 8 weeks after last monovalent dose
2 doses monovalent Pfizer -
BioNTech and 1 dose bivalent
Pfizer -BioNTechNA; previously received 1
bivalent vaccine doseNA NA NA NATable 1. COVID -19 vaccination schedule for people who are NOT moderately or severely immunocompromised
by COVID -19 vaccination history, April 2023 :Ages 6 months –4 years
COVID -19 vaccination history Bivalent vaccine Number of bivalent
doses indicatedDosage (mL/ug) Vaccine vial cap and label colors Interval between doses
UnvaccinatedModerna
___or___20.25 mL/25 ug Dark blue cap; gray label borderDose 1 and Dose 2:
4–8 weeks
Pfizer BioNTech 1 0.2 mL/10 ug Orange
1 dose monovalent Moderna Moderna
___or___1 0.25 mL/25 ug Dark blue cap; gray label border 4–8 weeks after monovalent dose
Pfizer BioNTech 1 0.2 mL/10 ug Orange At least 8 weeks after monovalent dose
2 doses monovalent Moderna Moderna
___or___1 0.2 mL/10 ug Dark pink cap; yellow label border At least 8 weeks after last monovalent dose
Pfizer BioNTech 1 0.2 mL/10 ug Orange At least 8 weeks after last monovalent dose
2 doses monovalent Moderna
and 1 dose bivalent mRNA NA; previously received
1 bivalent vaccine doseNA NA NA NA
1 or more doses monovalent
Pfizer -BioNTech Pfizer -BioNTech10.2 mL/10 ug Orange At least 8 weeks after last monovalent dose
2 doses monovalent Pfizer -
BioNTech and 1 dose bivalent
Pfizer -BioNTechNA; previously received
1 bivalent vaccine dose NA NA NA NATable 1. COVID -19 vaccination schedule for people who are NOT moderately or severely immunocompromised
by COVID -19 vaccination history, April 2023 :Age 5 years

Summary: Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Centers for Disease Control and Prevention National Center for Immunization and Respiratory Diseases Photographs and images included in this presentation are licensed solely for CDC/NCIRD online…


Mpox 01 Sanchez 508

National  Center  for  Emergin  g and  Zoonoti  c Infectiou  s Diseases
Mpox Vaccine Work Group
Pablo Sanchez MD
*he +hio State ,ni-ersity.Na/on0ide Children1s 2ospital
Chair, ACIP Mpox Work Group
ACIP Meeting
February 22, 2023

      Mpox – 2istorical Context
  
– –

–
–
– R are, sometimes life-threatening infection
Endemic in parts of west and central Africa
Caused by monkeypox virus (which is an orthopoxvirus)
C
lade I (previously Congo Basin Clade)
Clade II (previously West African Clade)
Can spread from infected animals to people and then person-to-person
R espiratory secretions
Skin-to-skin contact with infected bodily fluids (e.g., fluid from lesions)
Fomites (e.g., shared towels, clothing, and bedding)

               Timeline of Notable Human Mpox Events*
-First human case
identified -Rural settings US outbreak from pet prairie dogs (cohoused with infected small mammals from Ghana): 47 cases Outbreak in Nigeria involving 17 states: 138 cases Multinational outbreak
Imported cases to UK and Israel: 3 Imported cases to UK, Singapore: 2 Imported human cases to UK and US: 3
1970 2003 2017 2018 2019 2021 2022
*During 1970-2021, mpox was known to be endemic in 9 African countries: Cameroon, Central African Republic,
Cote d’Ivoire, Democratic Republic of Congo, Gabon, Liberia, Nigeria, Republic of Congo, and Sierra Leone; during recent years, there has been a re-emergence of human cases after decades of no reported cases

      Person-to-person spread
 Historical outbreaks in Africa
– Associated with close skin-to-skin contact and contact with fomites
– Zoonotic exposure cause of most cases
– Few secondary cases among close contacts (e.g., household contacts)
 US outbreaks
– 2003: No secondary cases  no vaccinations offered
– 2021: No secondary cases  ACAM2000 offered to some contacts*
– 2022: Many secondary cases >1 million doses of JYNNEOS administered
*ACAM2000 was offered through a CDC Investigational New Drug Protocol that allows for vaccination after mpox exposure. Only contacts with high-
risk exposures were offered vaccine; none accepted.

    2021 ACIP Orthopoxvirus Vaccine Vote
 Use of orthopoxvirus vaccine, JYNNEOS, (licensed in 2019) for pre-exposure
vaccination of people at occupational risk for orthopoxvirus exposures
 2-dose series, subcutaneous administration
 Recommendations published June 3, 2022*
*https://www.cdc.gov/mmwr/volumes/71/wr/mm7122e1.htm

 Currently no ACIP recommendation for use of JYNNEOS
during outbreaks

  Current U.S. national mpox vaccination strategy*
Vaccination  befor  e exposur  e to
mpox virus Post-exposur  e prophylaxis
-Gay  , bisexual  , and  other  MSM  , transgender  or
nonbinar  y people  (including  adolescents  who  fal l into
the  aforementioned  categories)  who  in  the  pas t 6
months  have  had: -People who are known contacts to someone
with mpox and identified by public health authorities (for example, via case investigation,
contact tracing, or risk exposure assessment)
• New diagnosis of ≥ 1 sexually transmitted disease -People who are aware that a recent sex
• More than one sex partner partner within the past 14 days was diagnosed
-People with the following in the last 6 months: with mpox
• Sex at commercial sex venue -Gay, bisexual, or other MSM, and transgender
• Sex  in  a
ssociation  with  large  public  even  t in
geographic  area  where  mpox  transmission  is
occurring or no
nbinary people (including adolescents
who fall into any of the aforementioned
categories) who have had any of the following
-Sexua  l partners  o f people  with  the  above  risks wit
hin the past 14 days: sex with multiple
-People  who  a nticipate  experiencing  above  risks
-People  with  HI V o r othe  r causes  o f
immunosuppression  who  have  had  recen  t or
anticipate  potentia  l mpox  exposure par
tners (or group sex); sex at commercial sex
venue; or sex in association with an event, venue, or defined geographic area where mpox
 transmission is occurring
*https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html

          U.S. strategy for vaccination with JYNNEOS during
current outbreak
 Intradermal preferred but subcutaneous can be administered for persons
aged ≥ 18 years
 Subcutaneous for persons aged <18 years*
 2-dose series with second dose administered 1 month after first dose
*https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html

                Tentative timeline for ACIP discussions and votes*
Mpo  x outbreaks  : Use  o f 2-dose  JYNNEOS
for  person  s age  d <1  8 year  s
-Update  s abou  t vaccine  effectivene  ss an  d
safety Mpo  x outbreaks  : Use  o f 2
dose  JYNNEOS  for  persons
age  d ≥  18  years - Consider  n ee  d for  longer  ter  m
vaccinatio  n strateg  y for  2-dose
JYNNEOS
Februar  y 2023 June 2023 October  2 023
*February 2023 and June 2023 votes do not impact existing recommendations for the current mpox outbreak.
D https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html

                Tentativ  e timeli  ne fo  r ACI  P discussio  ns  and votes*
       Current US mpox vaccination strategy remains active: Populations
Current   U.S.  mpox vaccinati  on strategy  re mai n at high risk should continue to be vaccinated. s in effect
Februar  y 2023 June  2023 October  2 023
*February 2023 and June 2023 votes do not impact existing recommendations for the current mpox outbreak.
D https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.htmlMpox outbreaks: Use of 2 -
dose JYNNEOS for persons
aged ≥ 18 years Mpo  x outbreaks  : Use  o f 2-do se  JYNNEOS
for  person  s age  d <1  8 year  s
-Update  s about  vaccine  effectivene  ss an  d
safety    Consider need for longer
   term vaccination strategy
for 2-dose JYNNEOS

 Goal for today’s meeting
 Updates from the ongoing outbreak
– Epidemiology: Sascha Ellington
– Vaccine effectiveness: Anna Chard
– Vaccine safety: Jonathan Duffy
– Community engagement: Kevin Delaney
– Equity and implementation: Rosalind Carter
 Discuss use of 2-dose JYNNEOS (subcutaneous) during mpox outbreaks
– Evidence to recommendations (EtR) framework: Agam Rao
– ACIP vote

     Proposed wording for today’s vote
ACIP recommends the 2-dose* JYNNEOS vaccine series for persons
aged 18 years and older at risk of mpox during an mpox outbreak§
*Dose 2 administered one month after dose 1
§ Public health authorities determine whether there is an mpox outbreak; a single case may be considered
an mpox outbreak at the discretion of public health authorities. Other circumstances in which a public
health response may be indicated include ongoing risk of introduction of mpox into a community due to
disease activity in another geographic area.

    WG members
ACIP Member
Pablo  Sánchez
Beth Bell
Ex Officio and Liaison Members
CSTE:  Chris  Hahn  / Paul  Cieslak
ASTHO: Ericka McGowan
N
ACHO: Philip  Huang
FDA:  Sixun  Yang,  Clemen  t
Meseda &  A lonzo  García
ACOG: Howard  Minkoff
AAP: Jim Campbell AIM:  Rob Schechter /  Jane  Zucker
APHL  :  J afar Razeq
NIH:  Janet  Lathey / Kimberly  Taylor
IHS: Matthew Clark
NACI:  Nicole Forbes  / Oliver  Baclic
IDSA:  Shireesha Dhanireddy /  Rajesh Gandhi
Invite  d Consultants
Subject  matter  experts: Inger  Damon,  Stuar  t
Isaacs,  Mike  Merchlinsky &  Amanda
Zarrabian (HHS/BARDA) Clinician  experts  in STIs,  HIV, pediatrics  ,
maternal  vaccination,  vaccine  safety,  health
equity,  smallpox  vaccination  strategies  ,
occupational  health

   Clinician experts
STIs, HIV, and mpox
(adult and peds): Jason  Zucker
J
eanne  Marrazzo
P
ablo  Tebas
Vince Marconi
Kim Workowski
Bonnie Maldonado
Immu
nizations (including for special
populations) and vaccine safety: Ruth Karron
F
lor Munoz-Rivas
K
athy Edwards Health  eq uity,  vaccination  strategi  es
includin  g fo  r smallpox:
Joel Breman
Gerard Vong
O
ccupational  Med icin  e and  work  er safety:
Mark  Russi

 CDC contributors
Mpox epi, lab, and vaccine experts
Brett  P etersen Andrea  Mc
Collum
Christy  Hutson
Laborator  y Respons  e Network:
Julie  Villanueva
Inf
ection control, worker safety:
Marie de Perio David Kuhar
Special populations (e.g., Persons
experiencing homelessness) Emily Mosites Vaccine safety
Michael  McNeil
Jonathan  Duffy
R
egulatory Affairs
Yon Yu
STIs and HIV
Laura  Bachmann
Leandro  Mena
John  Brooks
A
lexa Oster Dr ug Services
Julian Jolly
Vaccine
implementation
L
iz Velasquez
James  Lee
Do
D Liaison to CDC
Alan Lam
Work group lead
Agam Rao

          Thank you!
For more information, contact CDC
1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Summary: National  Center  for  Emergin  g and  Zoonoti  c Infectiou  s Diseases Mpox Vaccine Work Group  Pablo Sanchez MD  *he +hio State ,ni-ersity.Na/on0ide Children1s 2ospital  Chair, ACIP Mpox Work Group  ACIP Meeting  February 22, 2023                                                                 Mpox – 2istorical Context      – –    –  –  – R are, sometimes life-threatening infection  Endemic in parts of west and central Africa  Caused by monkeypox virus (which is an orthopoxvirus)  C lade…


Mpox 02 Ellington 508

Epidemiology  of Mpo  x
during  the Curre  nt
Outbreak

Sascha  Ellington,  PhD,  MSPH
Epidemiology  Task  Force
2022  Multinational  Mpox  Response
Centers  for Disease  Control  and  Prevention
February  22, 2023
    Epidemiology of the Current Outbreak
21

     en
l,
n2022-2023 Spread of Mpox in U.S.
• The first U.S. case was confirmed in
May 2022.
• At first, spread was associated with
international travel.
• More than 30,000 U.S. cases have be reported; new cases are declining.
• Most cases have been in gay, bisexua
& other men who have sex with men.
• Cases have also been reported in me who do not have sex with men,
cisgender and transgender women,
transgender men, gender-diverse
people, children, and teens.
Data as of February 8, 2023

 U.S. Mpox Case Trends as of February 9,
2023

      *   Sex / Gender Cases Percent
 Cisgender men 28,010 95.1%
 Cisgender women 854 2.9%
 Transgender men 76 0.3%
 Transgender women 266 0.9%
 Another sex/gender 235 0.8%
 Missing gender 728 -
      Mpox cases reported to CDC by age and
sex/gender
*Sex/Gender is available for 97.6% of cases
Data as of February 8, 2023
Median Min Max
34 < 1 89

     Mpox cases reported to CDC by race and
ethnicity
Race / Ethnicity*+ Count Percent
Black or African
American 9,331 33.1%
Hispanic or Latino 8,773 31.1%
White 8,258 29.3%
Asian 789 2.8%
Other Race 690 2.4%
Multiple Races 151 0.5%
American Indian or Alaska Native (AI/AN) 111 0.4%
Native Hawaiian or Other Pacific Islander 68 0.2%
(NH/OPI)
Missing 1,998 -
*All cases reporting Hispanic ethnicity are classified into
the Hispanic or Latino category
+Race/Ethnicity available for 93.4% of cases
Data as of February 8, 2023

 Clinical Characteristics of Mpox Cases
Reported to CDC as February 9 , 2023
Characteristic Percentage
HIV Status*
HIV Positive 53%
HIV Negative 47%
Rash location**
Genitals or perianal area 65%
Trunk or limbs 62%
Head, face, mouth 54%
Palms or soles of feet 24%
Hospitalized Yes 7.7%
No 92%
*HIV status available for 9,039 (30%) of mpox cases
**Rash location available for 14,902 (49%) of mpox cases 32 mpox associated
deaths (0.1% of all cases) reported in the U.S.

            Detection and transmission of mpox
during the current outbreak
• Spread primarily through sexual or close intimate contact
• Other routes of transmission have been reported
 Household transmission
 Injury with contaminated sharp instrument in clinical setting
 Piercing and tattooing
 Perinatal transmission
• Some people can spread mpox virus to others 1-4 days before symptom onset reported (i.e. pre-symptomatic transmission)
• No evidence that people who are infected but never develop symptoms can spread mpox
https://www.cdc.gov/poxvirus/monkeypox/about/science-behind-transmission.html

       Detection and transmission of mpox
during the current outbreak
Mpox Virus in Human Samples and Implications for Transmission
Exposure source Mpox virus DNA detected by PCR Replication-competent virus
detected/isolated Epidemiologically supported source of infection
Skin Yes Yes Yes
Oropharynx and saliva Yes* Yes Yes
Anorectum Yes Yes Yes†
Semen Yes* Yes Insufficient data
Urine/urethra Yes Yes Insufficient data
Conjunctivae or ocular fluid Yes Yes Insufficient data
Blood/plasma/serum Yes Insufficient data Insufficient data
Feces Yes Insufficient data Insufficient data
Vagina Yes Insufficient data Insuﬃcient data†
Breastmilk Insufficient data Insufficient data Insufficient data
Contaminated sharp‡ Insufficient data Insufficient data Yes
* DNA has been detected at Ct values <35 in recovered patients more than 30 days after illness onset in an upper respiratory tract swab, saliva, and semen.
† The preponderance of existing data support exposure to anorectal and vulvovaginal tissues and %uids as capable of transmitting infection; however, it is difficult with current evidence to definitively isolate these exposures
from other concomitant exposures (see text).
‡ Includes body modi+cation with piercings and tattooing.
https://www.cdc.gov/poxvirus/monkeypox/about/science-behind-transmission.html

      MMSC* among
Men** Cases Percent
  Men, recent MMSC 14,143 75.4%
   Men, no recent MMSC 4,612 24.6%
Missing 9,331 -

     Mpox cases among men reported to CDC by
sexual contact history
*MMSC= male-male sexual contact
**Sexual contact history and gender
available for 66.8% of cases among men
Data as of February 8, 2023

 Epidemiology of Mpox in Less Affected
Populations
30

 Percentage  among
Cisgender  wom  en
(n=769) Characteristic
Age
 Median (Range)  32 (15–89)
  Race and ethnicity
 Black, non-Hispanic 44%
 White, non-Hispanic 25%
 Hispanic or  Latino 23%
 HIV Status*
  HIV positive 8%
 HIV  negative 92%
     Recent sexual or close intimate partner** 71%

 Mpox in Cisgender Women in the United
States, May 11–November 7, 2022
2.7% of all cases
reported to CDC were among cisgender women
*HIV  status  available  for 17 3 (22%)  cisgender  women
**Define  d as within  last 3 weeks;  data  available  for  463 (60%)  cisgender  women
Source: http://dx.doi.org/10.15585/mmwr.mm7201a2

 Mpox in Pregnant and Recently Pregnant
People in the U.S.
• From May 11-November 7, 2022, 21 cases of mpox reported to CDC occurred in pregnant
people and 2 reported cases occurred in people who were recently pregnant (within 3 weeks of delivery)
• Among those with exposure data (n=12): 9 with sexual contact and 3 with household contact
• Similar signs and symptoms of mpox as those in non-pregnant people
 4 cases with genital lesions during pregnancy
• Tecovirimat provided to 48% of people with mpox during pregnancy with no adverse events
reported
• None received post-exposure prophylaxis with JYNNEOS
• Outcomes
 Four hospitalizations for mpox indications. All discharged while still pregnant.
 No pregnant patients required intensive care, intubation, or unplanned delivery
 3 pregnancy outcomes: 2 uncomplicated live births (no transmission to the infant); 1 first trimester spontaneous
abortion
 Two recently pregnant persons experienced symptoms within 3 days of delivery and their newborns developed lesions within a week
Source: http://dx.doi.org/10.15585/mmwr.mm7201a2

 Percentage among
transgender and gender-
Characteristic diverse persons
Age
Median (Range)
Race and ethnicity
Bl
ack, non-Hispanic
White, non-Hispanic
Hispanic or Latino
HIV Status
HIV positive
HIV negative
Recent sexual or close
intimate partner 32 (18–71)
28%
28%
37%
48%
52%
84%

         Mpox in Transgender and Gender-Diverse
Adults — United States, May 17–November 4, 2022
Gender identity of transgender and
gender-diverse adults with mpox (n=466)
43%
15% 42% Transgende  r women
Transgende  r men
Gender-divers  e persons
96% of gender-diverse adults were assigned male sex at birth.
Source: http://dx.doi.org/10.15585/mmwr.mm715152a1 *HIV status available for 166 (36%) transgender and gender-diverse adults
**Defined as within last 3 weeks; data available for 378 (80%) transgender and gender-
diverse adults

 %by age group, yrs
0–4 5–12 13–17
Characteristic (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% Epidemiologic Characteristics of Pediatric Cases
in the U.S., May 17–September 24, 2022
Source: http://dx.doi.org/10.15585/mmwr.mm7144a4
  Vaccine Administration
35

120,000Doses administered 100,000
80,000
60,000
40,000
20,000
0 Total JYNNEOS Vaccine Doses Administered
and Reported to CDC by week
1,185,907 doses administered and reported to CDC since May 20, 2022
First doses
Second doses 5/22-5/28
5/29-6/4
6/5-6/11
6/12-6/18
6/19-6/25
6/26-7/2
7/3-7/9
7/10-7/16 7/17-7/23
7/24-7/30
7/31-8/6
8/7-8/13
8/14-8/20
8/21-8/27
8/28-9/3
9/4-9/10
9/11-9/17
9/18-9/24
9/25-10/1
10/2-10/8
10/9-10/15
10/16-10/22 10/23-10/29
10/30-11/5
11/6-11/12
11/13-11/19
11/20-11/26
11/27-12/3
12/4-12/10
12/11-12/17
12/18-12/24
12/25-12/31
1/1-1/7
1/8-1/14
1/15-1/21
1/22-1/28
1/29-2/6
     Data as of February 7, 2023

     Mpox Cases and Vaccine Recipients by Race
and Ethnicity
100% 0.2%
90%
80% 70% 60%
50%
40%
30% 20% 10%
0% 2.4%
2.8%
29% 0.4%
0.5% 2.7%
3.6% 0.3%
0.4%
7.3%
52%
31%
22%
33%
13%
Mpox Cases (N=28,171*) Mpox Vaccine Recipients** (N=704,728) Nativ  e Hawaiia  n or  Other  Pacific
Islander
America  n India  n or  Alaska  Native
Multipl  e Races
Othe  r Race
Asian
White Hispani  c o r Latino
Blac  k o r Africa  n American

                 *
Race and ethnicity available for 93% of mpox cases reported
**Based on 1st dose; Data as of February 9, 2023; race and ethnicity available for 91% of first doses administered

Summary: Epidemiology  of Mpo  x  during  the Curre  nt  Outbreak   Sascha  Ellington,  PhD,  MSPH  Epidemiology  Task  Force  2022  Multinational  Mpox  Response    Centers  for Disease  Control  and  Prevention  February  22, 2023      Epidemiology of the Current Outbreak  21                                                                                en l, n2022-2023 Spread of Mpox in U.S.  • The first U.S. case was confirmed in  May 2022.  • At first, spread was associated with  international…


Mpox 03 Duffy 508

National  Center  for Emergin  g and  Zoonotic  Infectious  Diseases
JYNNEOS Vaccine Safety Monitoring During the 2022
Mpox Outbreak ─ United States
Jonathan Duffy, MD, MPH
Immunization Safety Office Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices
February 22, 2023

      CDC Mpox vaccine safety data sources
 Vaccine Adverse Event Reporting System (VAERS)
 Vaccine Safety Datalink (VSD)
 V-safe after vaccination health checker
 Single-patient emergency Investigational New Drug (EIND) procedures

VAERS
         VAERS is the nation’s early warning system for vaccine
safety

  JYNNEOS EUA* required reporting to VAERS for
adverse events and vaccine administration errors
 The vaccination provider is responsible for MANDATORY reporting of the
following listed events following JYNNEOS to VAERS:
– Vaccine administration errors whether or not associated with an adverse event
– Serious adverse events (irrespective of attribution to vaccination)
– Cases of cardiac events including myocarditis and pericarditis
– Cases of thromboembolic events and neurovascular events
*EUA indications: intradermal injection for individuals aged ≥18 and subcutaneous injection for individuals aged <18 years; Fact Sheet
for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Jynneos (Smallpox and Monkeypox
Vaccine, Live, Non-Replicating) for Prevention of Monkeypox Disease in Individuals Determined to be at High Risk for Monkeypox Infection (fda.gov)

  VAERS: JYNNEOS surveillance methods
 VAERS reports received and processed by January 20, 2023
 Adverse event reporting rates were calculated by dividing the number of
VAERS reports by the number of vaccine doses administered in the U.S.
– Vaccine doses administered during May 22–January 13 and reported to CDC by January 23, 2023
• Dose 1: 698,188
• Dose 2: 426,980
• Total: 1,125,168

  VAERS: JYNNEOS report characteristics, n = 1,817
Characteristic n (%)
Sex
Male 1,415 (78)
Female 238 (13)
Not reported 164 (9)
Age
0-17 25 (1)
18-64 1,501 (83)
≥65 83 (5)
Not reported 208 (11)
Other vaccines on same day
Yes 45 (2)
No 1,772 (98) Characteristic n (%)
Dose in series
1 1,013 (56)
2 471 (26)
Not reported 333 (18)
Route of administration
Intradermal 1,001 (55)
Subcutaneous 378 (21)
Intramuscular 211 (12)
Not reported 227 (12)

     VAERS: vaccine administration error reports
 Represent 50% of all JYNNEOS VAERS reports
– Of these, 96% did not report an adverse health event
 Error reporting rate
– Intradermal: 937 per million doses administered
– Subcutaneous: 306 per million doses administered
 Errors frequently reported with attempted intradermal administration:
– Absence of a wheal without vaccine leakage (42%)
– Vaccine leakage from injection site (12%)

rate

 All adverse health events VAERS: adverse health event reporting rates per
million doses administered by route of administration

 Intradermal rate
All adverse health events 685
Injection site erythema 152 Dizziness 129
Injection site swelling 112
Urticaria 110
Injection site pruritus 93
Erythema 78
Syncope 73
Pruritus 72
Hyperhidrosis 70
Loss of consciousness 69 Injec  tion sit  e erythema
  Injection site swelling
  Injection site pain Pain 107
107
99 96
Fatigue Erythema Headache 80 77 77
Dizziness 74
  Injection site pruritus Pyrexia 66 66 Subcutaneous
639

        Serious Adverse Event definition
 Death
 A life-threatening adverse event
 Inpatient hospitalization or prolongation of existing hospitalization
 A persistent or significant incapacity or substantial disruption of the ability
to conduct normal life functions
 A congenital anomaly/birth defect
 An important medical event that based on appropriate medical judgement
may jeopardize the individual and may require medical or surgical
intervention to prevent one of the outcomes listed above

     VAERS: serious adverse events reported after JYNNEOS*,
n = 26
SAE reporting rate: 22 reports per million doses administered

 

 
 
 
 
 
 
   Dehydration Myocarditis  (n =5)
Death  (n=2)** Idiopathic thrombocytopenic
pur
pura Pericarditi  s (n=2)
In
jection site discoloration Urticari  a (n=2)
In
jection site pain Appendicitis
Injection site scar Asepti  c meningitis
Met
hemoglobinemia Asthenia
Retrograde amnesia Atrial  fibrillation
Rha
bdomyolysis Cellulitis
Sudden hearing loss Chest  pain
*The report of an adverse event to VAERS is not documentation that a vaccine caused the event.
**Reported causes of death: drowning, cocaine toxicity.
Myocarditis and pericarditis

   Myocarditis and pericarditis
 Myocarditis and pericarditis have occurred following either primary
vaccination or revaccination with live vaccinia virus smallpox vaccines
– The mechanism is poorly understood, and it was unknown whether persons who receive JYNNEOS might experience myocarditis or pericarditis
 Epidemiologic analysis groupings:
– Myocarditis with or without pericarditis
– Pericarditis
 Surveillance risk interval: symptom onset within 30 days after vaccination
Case definitions available at: DOI: 10.15585/mmwr.mm7027e2

   Myocarditis rate per million persons during 30-day period
Observed after JYNNEOS
Data source Dose 1
cases doses rate per million
(95% CI) Dose 2
cases doses rate per million
(95% CI)
VAERS 2 726,851 2.75 (0.33–9.94) 3 445,019 6.74 (1.39–19.70)
Vaccine Safety
Datalink 1 37,646 27 (0.67–148) 1 21,919 46 (1.15–254)
Expected
 Historical myocarditis population background rates per million persons:
– U.S. military in 20021: 21.6
– MarketScan database, males 18–64 yrs in 2017–20192: 2.7 – 7.5
 Historical myocarditis rates after live, replicating smallpox vaccines (Dryvax or ACAM2000) ranged from 78 to 5,230 cases per million persons
1,3
References:
1) Halsell, et all. DOI: 10.1001/jama.289.24.3283; 2) Oster, et al. DOI: 10.1001/jama.2021.24110 ;
3) Mandra, et al. DOI: 10.1017/dmp.2020.478

   Pericarditis rate per million persons during 30-day period
Observed after JYNNEOS
Data source Dose 1
cases doses rate per million
(95% CI) Dose 2
cases doses rate per million
(95% CI)
VAERS 4 726,851 5.50 (1.50–14) 2 445,019 4.49 (0.54–16.23)
Vaccine Safety
Datalink 0 37,646 0 0 21,919 0
Expected
 Historical pericarditis population background rates per million persons:
– Italy, 2001–20051: 22.8
– U.S. Nationwide Inpatient Sample database, 2003–20122: 4.7
 Historical pericarditis rate after live, replicating smallpox vaccines (Dryvax
or ACAM2000) was 925 cases per million persons in one U.S. military study3
References:
1) Imazio, et al. DOI: 10.1136/hrt.2006.104067; 2) Kumar, et al. DOI: 10.1159/000445206 ;
3) Engler, et al. DOI:10.1371/journal.pone.0118283

V-safe

   V-safe Mpox: active vaccine safety monitoring
 Smartphone-based system that uses text messaging to initiate web-based
survey monitoring for adverse events following vaccination
 V-safe is used to:
– Characterize the basic safety profile of a vaccine when given outside a clinical trial setting
– Provide information for public health communication around vaccine safety
– Facilitate reporting to the Vaccine Adverse Event Reporting System (VAERS)
for medically attended adverse events following vaccination
 V-safe supplements CDC’s other vaccine safety monitoring systems, VAERS and
Vaccine Safety Datalink (VSD)

V-safe Mpox: characteristics of active participants*
Characteristic N=181
n (%)
Age in years
18-49 112 (61.9)
50-64 56 (30.9)
≥65 13 (7.2)
Gender identity
Male 139 (76.8)
Female 28 (15.5)
Transgender 7 (3.9)
None of the above or
unknown 7 (3.9)
Immunocompromised** 32 (17.1) Characteristic N=181
n (%)
Race/Ethnicity
White, non-Hispanic 111 (61.3)
Hispanic 28 (15.5)
Asian, non-Hispanic 11 (6.1)
Black, non-Hispanic 10 (5.5)
Multiracial, non-Hispanic 10 (5.5)
Other race, non-Hispanic 2 (1.1)
Unknown race or ethnicity 9 (5.0)
*active participants defined as having completed at least one
survey, November 16, 2022 – January 29, 2023 **defined as self-report of immunocompromising condition or taking immunosuppressive medications at the time of vaccination

          V-safe Mpox: reactions and health impact events reported by v-safe
participants at least once in days 0-7 after vaccination, by dose
100
90
81
62
26
19
14
5 80
54
16 14
10
0
0 10 20 30 40 50 60 70 80 Percentage
Any injection site reaction Any systemic reaction Any health impact Unable to perform normal Unable to work or attend Sought medical care (clinic
daily activities school only)
Dose 1 Dose 2
Includes 42 participants who completed at least one survey after dose 1 and 50 participants who completed at least one survey
after dose 2, data collected November 16, 2022 – January 29, 2023

          V-safe Mpox: top injection site and systemic reactions reported by v-safe
participants at least once in days 0-7 after Mpox vaccination, by dose
100
90
80 70
6462
60 50
40
30 20 10
0
Redness at site Itching at site Lump at site Swelling at site Fatigue Headache Pain at site Myalgia Rash at site Fever 55 52 50
40
24 24 24
17 17 54
46
40 42
28 26
22
16
6
Dose 1 Dose 2
Includes 42 participants who completed at least one survey after dose 1 and 50 participants who completed at least one survey
after dose 2, data collected November 16, 2022 – January 29, 2023 Percentage

Adverse  Events  in  persons  <18 years  of age

     Single-patient emergency  Investigational  New  Drug
(EIND) procedures


 CDC facilitate  d JYNNEOS EIND  authorization  s fro  m FDA  fo r 65 person  s aged  <1 8
year  s prior  to  the  EUA  being  issue  d o  n August  9,  2022
– CDC  solicite  d informatio  n fro  m vaccine  provider  s about  adverse  event  s
occurring  durin  g the  28 day  s afte  r each  dose
 Ages: 4 months to 17 years
 Sex: 58% male
 Adverse events reported:
– D
ose 1: 10 (18%) of 57
– Dose 2: 5 (21%) of 24
– Injection site reactions: pain, erythema, swelling, and induration
– Systemic adverse events: fever, fatigue, and headache
 No serious adverse events were reported

    VAERS: reports for persons aged <18 years
 JYNNEOS vaccine was administered to 1,245 persons aged <18 years in the
U.S during this surveillance period
 VAERS received 25 reports for persons aged <18 years
– Ages from 12 through 17 years
– Vaccine administration errors, n = 21 (84%)
• e.g., administered intradermal dose instead of subcutaneous dose
– Only 1 adverse health event reported: syncope
– No serious adverse events reported

Conclusions

   Conclusions
 JYNNEOS post-licensure and post-authorization vaccine safety surveillance
findings to date are consistent with those observed in clinical trials
 No new or unexpected safety concerns have been identified
 Serious adverse events were rare among adults, and none have been identified among persons aged <18 years
 VAERS and Vaccine Safety Datalink data do not suggest an increased risk for myocarditis or pericarditis following JYNNEOS, but the possibility of a small risk cannot be excluded

         For more information, contact CDC
1-800-CDC-INFO (232-4636) TTY: 1-888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the Centers for Disease Control and Prevention.

Summary: National  Center  for Emergin  g and  Zoonotic  Infectious  Diseases  JYNNEOS Vaccine Safety Monitoring During the 2022  Mpox Outbreak ─ United States  Jonathan Duffy, MD, MPH  Immunization Safety Office Centers for Disease Control and Prevention  Advisory Committee on Immunization Practices  February 22, 2023                            CDC Mpox vaccine safety data sources   Vaccine Adverse Event Reporting System (VAERS)   Vaccine Safety Datalink (VSD)   V-safe after vaccination health…


Mpox 04 Chard 508

National  Center  for Emerging  and Zoonotic  Infectious  Diseases
JYNNEOS Vaccine Effectiveness
Anna Chard, PhD, MPH
LT, US Public Health Service
Vaccine Effectiveness Team
Vaccine Task Force
2022 Multinational Mpox Outbreak Response
Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices
February 22, 2023

         Background
 Efficacy of JYNNEOS against mpox has been inferred from animal and
immunogenicity studies, but has never been demonstrated in clinical trials
 Noreal-world vaccine effectiveness (VE) estimates for JYNNEOS against
mpox disease prior to current multinational outbreak
 Key questions:
1. What is the effectiveness of JYNNEOS vaccine against mpox disease?
a) What is VE of partial (1 dose) versus full (2 doses) vaccination?
2. Are there differences in VE by route of vaccine administration?
3. Are there differences in VE among persons with immunocompromising conditions?
4. What is the duration of protection conferred from JYNNEOS vaccine?

  Organization of presentation
 Vaccine performance
 Incidence of mpox among unvaccinated persons versus persons receiving ≥1 JYNNEOS
dose in the United States (U.S)
 Vaccine effectiveness (VE) of JYNNEOS given as post-exposure prophylaxis
(PEP) against mpox disease, New York City
 VE of JYNNEOS given as pre-exposure prophylaxis (PrEP) against mpox
disease
1. Israel single dose VE Study : Real-world effectiveness of a single dose of mpox vaccine
in males
2. EPIC Cosmos Case-Control Study: VE of 1 and 2 doses against mpox disease in the U.S
3. Multi-jurisdictional Case-Control Study : Interim estimate of VE of 2 doses against
mpox disease in 12 U.S. jurisdictions
4. New York State Case-Control Study : Preliminary estimates of VE of 1 and 2 doses
against mpox disease
Vaccine  performance

            Weekly mpox incidence by vaccination status: Methods
 Data sources: Mpox case data, vaccine administration data, estimates of the
vaccine eligible population*
 Design: Comparison of mpox incidence among persons who were
unvaccinated and those who had received either 1 or 2 JYNNEOS doses
 Population: 9,544 reported mpox cases among men aged 18–49 years from
43 U.S. jurisdictions
 Time period: July 31–October 1, 2022
 Analysis:
 Estimated weekly mpox incidence for persons with partial (1 dose) and full (2 doses)
vaccination and persons eligible but unvaccinated
 Calculated incidence rate ratio using negative binomial regression
*Estimated population per jurisdiction of men who have sex with men (MSM) who are living with HIV or MSM who are eligible for HIV pre -
exposure prophylaxis.
Source: Payne AB, et al. Reduced Risk for Mpox After Receipt of 1 or 2 Doses of JYNNEOS Vaccine Compared with Risk Among Unvaccinated
Persons — 43 U.S. Jurisdictions, July 31–October 1, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1560–1564.

              July 31, 2022 – October 1, 2022 (43 U.S. jurisdictions**)
Unvaccinated
350
300
250
200 150
100
50
0 Vaccine dose 1 received ≥ 14 days earlier
Vaccine dose 2 received ≥ 14 days earlier Monkeypox Incidence
31-Jul-22
2-Aug-22 4-Aug-22 6-Aug-22 8-Aug-22
10-Aug-22 12-Aug-22 14-Aug-22 16-Aug-22 18-Aug-22 20-Aug-22 22-Aug-22 24-Aug-22
26-Aug-22
28-Aug-22 30-Aug-22
1-Sep-22 3-Sep-22 5-Sep-22 7-Sep-22 9-Sep-22
11-Sep-22 13-Sep-22
15-Sep-22
17-Sep-22 19-Sep-22 21-Sep-22 23-Sep-22 25-Sep-22
Week
  Weekly mpox incidence,*by vaccination status
eligible for vaccination§among males aged 18–49 years

 Mpox incidence among unvaccinated
individuals was 7.4 (95% CI = 6.0–9.1) times
as high as persons receiving 1 dose of
JYNNEOS vaccine .
Mpox incidence among unvaccinated
individuals was 9.6 (95% CI = 6.9–13.2)
times as high as persons receiving 2 doses
of JYNNEOS vaccine .
No difference observed in vaccine
performance be tween subcutaneous and
intradermal administration .
* 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 or second 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. § 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. ¶ Alabama, Alaska, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Mexico, New York (excluding New York City), North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming. ** 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.
Source : Payne AB, et al. Reduced Risk for Mpox After Receipt of 1 or 2 Doses of JYNNEOS Vaccine Compared with Risk Among Unvaccinated Persons — 43 U.S. Jurisdictions, July 31–October 1, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1560–1564.

Vaccine effectiveness  of JYNNEOS
administered  as PEP against  mpox

            JYNNEOS effectiveness as PEP against mpox, New York City
(unpublished data)
 Design: Cohort evaluation of individuals ages >18 years residing in NYC identified through
routine Department of Health contact investigations to a case-patient with mpox between May
22—August 24, 2022 and no vaccination or disease history prior to exposure
 PEP: Receipt of 1st dose of JYNNEOS <14 days of exposure and prior to date of symptom onset,
if applicable
 Case-patient : Exposed individuals who developed symptom onset <21 days after exposure
(incubation period) with laboratory confirmation
 Analysis : VE of a single dose of JYNNEOS administered subcutaneously <14 days after exposure
as PEP for preventing laboratory-confirmed mpox disease as [(1 – Relative Risk) × 100%]
 Results: Among individuals with high-risk* exposure, vaccine effectiveness was 77% (95% CI:
51%-92%) with PEP <14 days after last exposure (n=273) and 79% (46%-94%) with PEP <14
days after first exposure (n=208)**
*Defined according to the CDC Interim Community Exposure Risk Assessment and Recommendations
***Unadjusted; in univariate analyses, race/ethnicity and age-group were not significantly associated with mpox disease

Vaccine effectiveness of JYNNEOS
administered as PrEP against mpox

                   Israel single-dose VE study: Methods


 V accination: Single, subcutaneous dose of Modified Vaccinia Ankara-Bavarian
Nordic (MVA-BN)
 Design:  Retrospective,  observational cohort  using electronic  health  record  s
from  a singl  e integrated  health  center  in  Israel
 Population:  2,054  men  eligible*  for  vaccinati  on
 Time  period:  July 31 , 2022  – December 25 , 2022
 Analysis  :
 VE estimated  using  Co x proportional  hazards  regressio  n with  vaccination  status  as  a
time-varyi  ng covariate
 M
odel adjusted for sociodemographic and clinical risk factors
*Males aged 18 – 42 years who were dispensed HIV-PrEP at least for one month since January 1, 2022, or (b) males aged 18 – 42 years who were diagnosed with HIV
and also were diagnosed with one or more sexually transmitted infections (STIs) since January 1, 2022.
Source : Sagy, Y. W. et al. Real-world effectiveness of a single dose of mpox vaccine in males. Nature Medicine https://doi.org/10.1038/s41591-023-02229-3 (2023).

 Israel single-dose VE study: Results
• 5 mpox cases among vaccinated
individuals
• 16 mpox cases among
unvaccinated individuals
• Adjusted single-dose vaccine
effectiveness was 86% (95% CI: 59%-95%)
Source : Sagy, Y . W. et al. Real-world effectiveness of a single dose of mpox vaccine in males. Nature Medicine https://doi.org/10.1038/s41591 -
023-02229-3 (2023).

     Epic Cosmos Case-Control Study: Methods
 Data Source: Epic’s electronic health record (EHR) platform, Cosmos, which
includes records from >169 million patients across the U.S.






  Analysis:
 Design: Case-control analysis, matched 1:4 based on week of index event,
HHS region, and gender identity
Case patients:  Patients  wit  h an mpox diagnosis  or positive  orthopoxvirus or  mpox
virus  laboratory  result  from  8/15  - 11/19/2022
Control  patients : Patients  wit   h an incident  HIV diagnosis  or  HIV pre-exposur  e
prophylaxis  (PrEP) prescription  from  8/15  - 11/19/2022
VE estimated  using  conditional  logistic  regression
Adjusted  for age , race/ethnicity,  social  vulnerability  index  , immunocompromisin  g
conditions
Stratified  by route   of administration  and immunocompromised  status

  Cases Controls Adjusted* VE (95% CI) (n=2,913) (n=8,319)
Overall VE, full vaccination (2 doses) 25 335 66 (47, 78)
No immunocompromising conditions 14 312 76 (58, 87)
2 doses administered subcutaneously 6 63 54 (-9, 81) 2 doses administered intradermally 5 42 46 (-45, 80) 2 doses administered heterologously 8 150 75 (48, 88)
Overall VE, partial vaccination (1 dose) 146 1000 36 (22, 47)
No immunocompromising conditions 102 932 41 (25, 53) 1 dose administered subcutaneously 106 704 32 (15, 45) 1 dose administered intradermally 27 186 41 (7, 62)
-60 - 40 - 20 0 20 40 60 Vaccine Effectiveness (% )80 100

 Epic Cosmos Case-Control Study: JYNNEOS VE for fulland partial
vaccination, August 15-November 19, 2022, United States
(unpublished data)
*Adjusted for age, race/ethnicity, social vulnerability index, and immunocompromising conditions .
C
ases/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: Logistic regression with random intercept for jurisdiction and
adjusted for age, race/ethnicity, number of sexual partners, close contact with a confirmed/probable case, and month of index event

Multi-jurisdictional Case-Control Study Interim Results: VE for full
vaccination (unpublished data)
Cases Controls Adjusted* VE (95% CI) (n=167) (n=256)
Overall VE, full vaccination (2 doses) 14 122 76% (48%-89%)
No immunocompromising conditions 8 61 90% (66%-97%)
Immunocompromising conditions
Overall VE, partial vaccination (1 dose) Not sufficiently powered for interim analysis
No immunocompromising conditions
Immunocompromising conditions
0 20 40 60 80 100
Vaccine Effectiveness (%)
*Adjusted  for age, race/ethnicity,  immunocompromised  status,  reported  clos  e contact  with  a
confirmed/suspected  mpox cas  e in   3 week  s prior  to  index  event,  and month  o f index  event

New York State Case-Control Study: Preliminary Estimates
(unpublished data)
 Data source: Linkage of case surveillance to immunization registry in New York
State, excluding New York City
 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
 Analysis: Conditional logistic regression model adjusted for diagnosis week, race,
age, region within state
mpox cases
(n=252) STI controls
(n=255) VE (95% CI)
Partial vaccination 10 (4%) 23 (9%) 68% (25%, 86%) Unvaccinated 230 (91%) 204 (80%) ref.
Full vaccination 2 (1%) 19 (7%) 89%  (44%, 98%)
Summary

Cases Controls    Adjusted* VE (95%
Epic   Cosmos  case-control study 25 335  66% (47%- 78%)
 New   York State  case-control study 2 19  89% (44%-98%)
 Partial  vaccination  (1 dose)
5 16  86% (59%-95%)
Epic   Cosmos  case-control study 146 1000  36% (22%-47%)
  Vaccine effectiveness of JYNNEOS against mpox ranges from 66% -
89% for full vaccination and 36%-86% for partial vaccination
CI)
0 20 40 60 80 100
Vaccine Effectiveness (%)  Full  v accination  (2 doses)
 Mul
ti-jurisdictional  case-control study 14 122  76% (48%-89%)
  Israel single-dose study
 New   York State  case-control study 10 23  68% (25%-86%)

      Vaccine effectiveness of JYNNEOS against mpox




 JYNNEOS  vaccine i s effective at  reducing  risk  of mpox disease
 Protection  provided  by both  1  and 2 doses  of JYNNEOS  vaccine
 Highest  protection  provided  by 2 doses  , regardles  s of route of
administration
 Further  research  needed  to evaluate  whether  immunocompromised  statu  s
modulates  V E
 Further research needed to assess duration of protection

 Acknowledgements
• Alpha Oumar Diallo • Jennifer B. Rosen • Jemma Rowlands • Gennesis Quinonez
• Robert J. Arciuolo • Ghinwa Dumyati • Paola Santos • Alexandra Dalton
• Preeti Pathela • Christina Felsen • AmberJean Hansen
• Amy Fothergill • Jennifer Baumgartner • Erin Licherdell • James Meek
• Julia Latash • Kristin Smith • Linda Niccolai • Leora Feldstein
• Lenka Malec • Shealynn Hilliard • Quyen PhanLynn Sosa • Nicholas Deputy • Ellen H. Lee • Will Still • Sydney Jones
• Danielle Moulia • Vasudha Reddy • Allison Morrow • Gabriela Betancourt
• Renee King • Sarah Gillani • Ciarra Leocadio • Amanda Payne • Joseph Edward Real • Eric Anthony • Preeti Pathela
• Tom Shimabukuro • Jane R. Zucker • Mary Fran DeRose • Robyn Weber
• Jessica Castilho • Gregory Prahl • Mo Patel • Investigators from New York State Health • Mary Margaret Fill • Masayo Nishiyama
• Adam Cohen Dept • Keipp Talbot • Jesse J. Carlson
• Eli Rosenberg • Tiffanie Markus • Kevin Kamis • Rosalind Carter
• Vajeera Dorabawila • Danielle Ndi • Gena Simien • Amanda Cohn • Rachel Hart-Malloy • Kristine Mansilla-Dubon • Karen A. Wendel
• Daniel Payne • Wilson Miranda • Bentley Akok • Ginger Stringer
• Bridget Anderson • Sweta Tiwari • Rachel Herlihy • Logan Ray • Bryon Backenson • Caleb Wiedeman • Jennifer House
• Kristen Kugeler • Charlotte DelBarba • Jacqueline Logan • California Department of Public Health
• Meaghan Abrego • Greg Chambers • Alameda County Public Health • Michelle Canning Department (CA) • Yelena Tourkina • Cori Tice • Robbie Snyder • Matthew Cole • Kim Toevs • Claire McGarry • Shua Chai • Kennedy Houck • Emily Lutterloh • Lynn Rampe • Arthur L. Reingold • Eric Richardson • Michele Boulais • Steven Gibson • Nathaniel Lewis • Jaxon Mitchell • Ethan Mitchell • Eileen Dunne • Josh Arevalo • Jennifer Farrar • Charles Gonzalez • Rebecca Fisher • Melissa Sutton • Travis O’Donnell • Lizzie White • Phoebe Danza • Paul Cieslak • Michael Kharfen • Erin Peterson • Epic COSMOS Investigators • James McDonald • Sam Hawkins • Jane Lam • Jackie Gerhart • Ursula Bauer • Amber Britton
• Gabriel Garcia-Lopez • Danessa Sandman • Bianca Perez • Robert Bolan • Dave Little • Multi-jurisdictional case-control study • Erica Hazra • Sharon Balter • Cory Sweet investigators: • Molly McAlvany • Sonali Kulkarni • Joe Deckert • Taelor Moran • Bridget Anderson • Nava Yeganeh • Eric Barkley • Tamsin van der Woude • Suzanne McGuire • Andrea Kim • Neil Sandburg • Katherine Lee • Adam Rowe
• Rachael Gill • Kerianne Engesser • Investigators from NYC Health

1-800-CDC-INF  O (232-4636)
TTY:   1-888-232-6348
www.cdc.gov

Summary: National  Center  for Emerging  and Zoonotic  Infectious  Diseases  JYNNEOS Vaccine Effectiveness  Anna Chard, PhD, MPH  LT, US Public Health Service  Vaccine Effectiveness Team  Vaccine Task Force  2022 Multinational Mpox Outbreak Response  Centers for Disease Control and Prevention  Advisory Committee on Immunization Practices  February 22, 2023                                                                                Background   Efficacy of JYNNEOS against mpox has been…


Mpox 05 Delaney 508

x
Information on Mpox vaccine acceptability and uptake from cross-
sectional surveys
Kevin P . Delaney, PhD, MPH
Community Engagement and Vaccine Policy and Implementation Task Force 2022 Multinational Mpox Response Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices
February 22, 2023
www.cdc.gov/mpo
Information from US-based Clinicians
 Sermo – online community of >1.3 million clinicians
 Conducted a worldwide survey of physicians
July 31-August 1st; results reported 8/8/2022
• At that point (N=415 US-based clinicians)
• 69% said that the US did not have enough
mpox vaccine to handle the outbreak
 Brief updated survey (N=62) on 9/12/2022
• 66% had treated at least one patient with monkeypox
• 76% knew where to send patients for JYNNEOS vaccination
• 86% wanted to be able to offer vaccine in their practice
More at https://app.sermo.com/barometer/unitedstates

   Information from affected populations

Studies included
Study Timeframe Population Methods
Porter  Novelli August  –
Decemb
er 1 6 N= up to 371 LGBTQ+
Data  weighted  to matc  h
census  population Four  KAP surveys  in the general  populatio  n
includin  g LGBTQ+
AMETHST : Ame rica n
Transformative  HIV
Study Aug 9th –
November  15th
AMIS : America  n
Men’s Internet
Survey N = 824 GBMSM Emory  conducte  d a one-time  KAP survey  of
2021  AMIS  population  .
Survey  available
  he
re
October  6 –
D
ecember  31 N=3041  GBMSM Ongoin  g recruitment  of the 2022  AMI  S
survey  summarized  through  12/31

San Francisco  study
amon  g persons
experiencin  g
homelessness  (PEH) N= 2 73
57 with  higher  risk sexua  l
activity
35 GBMSM N=8,551 5
0% Blac  k and  Latinx
GBMSM Mon t
hly cross-sectional  surv ey to recruit
new  cohorts  of persons  at risk for HIV .
Questions  related  to mpox added  in 2022
Cross-sectional  s urvey  among  PEH to
understand  vaccine  acceptabilit  y and
coverage
  A
ugust  5 –
A
ugust  15
Oct 2 3rd –
November  5th

AMETHST : Ame rican
Transformative  HI V
Study Aug 9th –
November  15th N=8,551
50%  Blac  k and  Latinx
GBMSM Monthly  cross-sectional  survey  to recruit
new  cohorts  of persons  at risk for HIV .
Questions  related  to mpox  added  in 2022
AMIS : America  n
Men’s Internet
Survey
October  6 –
December  31 N=3041  GBMSM Ongoin  g recruitment  of the 2022  AMI  S
survey  summarized  through  12/31
San Francisco  stud  y
amon  g persons
experiencin  g
homelessness  (PEH) Oct 23rd –
November  5th N= 273
57 with  higher  risk sexua  l
activity
35 GBMSM Cross-sectional  survey  among  PEH t o
understand  vaccine  acceptabilit  y an  d
coverage Studies included
Timeframe Population Methods
 Porter Novelli August  –
D
ecember  16  N= up to 371 LGBTQ+
Data  weighted  to match
census  population Four  KAP surveys  in the general  populatio  n
includin  g LGBTQ+
August  5 –
August  15 N = 824 GBMSM Emory  conducte  d a one-time  KAP survey  of
2021  AMIS  population  .
Survey  available  here Study

        Methods
 Porter Novelli conducted 4 online general population surveys during fall
2022 on knowledge, attitudes, and beliefs of mpox-related topics
 Data are weighted to match U.S. Census proportions
 Survey includes a question about whether the individual “identifies as a
member of the LGBTQ+ community”
 Most responses remained stable across the 4 months
 In the December Survey we asked specific questions designed to more directly measure mpox vaccine acceptability and value
 All results here are stratified by LGBTQ+ status

               The population thinks that the vaccine is safe and
important
LGBTQ+ Status
Variable Overall, N =
1,3231 Part of LGBTQ+
Community, N
= 1471 Not part of
LGBTQ+
community, N
= 1,1761
The monkeypox vaccine is safe
Agree 36% (475) 51% (76) 34% (399)
Disagree 9.7% (128) 11% (16) 9.5% (112)
Don't Know
It is important for me to get the
monkeypox vaccine to protect myself against monkeypox 54% (721) 38% (56) 57% (665)
Agree 33% (440) 50% (74) 31% (366)
Disagree 30% (400) 18% (27) 32% (373)
Don't Know 37% (484) 32% (46) 37% (437)
1% (n)2Bolded numbers are significant p < .05, chi-squared test with Rao & Scott's second-order correction

    Studies included
Study Timeframe Population Methods
Porter Novelli August –
December 16 N= up to 371 LGBTQ+
Data weighted to match
census population Four KAP surveys in the general population
including LGBTQ+
AMETHST :Ame rican
Transformative HIV
Study Aug 9th –
November 15th N=8,551 50% Black and Latinx
GBMSM Monthly cross-sectional survey to recruit
new cohorts of persons at risk for HIV.
Questions related to mpox added in 2022
AMIS :American
Men’s Internet
Survey August 5 –
August 15 N = 824 GBMSM Emory conducted a one-time KAP survey of 2021 AMIS population.
Survey available here
October 6 –
December 31 N=3041 GBMSM Ongoing recruitment of the 2022 AMIS
survey summarized through 12/31
San Francisco study among persons
experiencing
homelessness (PEH) Oct 23
rd –
November 5th N= 273 57 with higher risk sexual
activity
35 GBMSM Cross-sectional survey among PEH to understand vaccine acceptability and
coverage

AMETHST: American Transformative HIV Study
 NIH funded study to build new cohorts of individuals at
risk for HIV
 FY1-FY2 (2022-2024): Build cohort, enrolling at least 5000 people at increased risk for HIV infection; at least 50% people of color
• AMETHST cohort will focus on the mechanisms
through which meth use increases bio-behavioral vulnerability to HIV.
• Added questions re: Mpox knowledge, vaccine uptake and behavior change to their screening questionnaires
• 8551 participants surveyed through 11/15/2022
https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-21-018.html

       WORRY ABOUT MPOX OVER THE LAST 2 WEEKS
34.0% 40.6%
58.0%
66.4%
66% 59%
42%
34%
Aug Sept Oct Nov
Some or more than half of the days Never

 While Mpox
concern has decreased over time, some concern remains

   >85% of respondents remain interested in vaccination
 Vaccine coverage nearly November
October
September
August
0% 20% 40% 60% 80% 100% doubled between August
and September
 As o f  November,  30.5%
received  at least  one dose
• ~90%  overall and  88%  of
the sample  fro  m
November  either  hav  e
been  vaccinated  or
would  like to be
vaccinated Vaccinated
Extremely likely to get vaccinated Li
kely to get vaccinated or unsure
Unlikely to get vaccinated

November
October Proportion that received at least one dose of vaccine
September
August
0 10 20 30 40 50 60 70 80 90 100
Other Latinx Black White

  Vaccine uptake by Month and Race/Ethnicity,
AMETHST recruitment survey August-November 2022
 In August, Black
participants had higher vaccine coverage than participants from other racial and ethnic groups

          Vaccine uptake by Month and Race/Ethnicity,
AMETHST recruitment survey August-November 2022
 In August, Black
participants had higher vaccine coverage than participants from other racial and ethnic groups
November
October Proportion that received at least one dose of vaccine
September
August
0 10 20 30 40 50 60 70 80 90 100
Other Latinx Black White

        least one dose of vaccine
November

  Vaccine uptake by Month and Race/Ethnicity,
AMETHST recruitment survey August-November 2022
 In A ugust,  Blac  k
participants  had higher
vaccine coverage than
participants from other
racial and ethnic groups
October
 But b lack  men  did no t
see the “doubling”   in
vaccine  coverage  tha t
we reported  overall September
August Proportion that received at
0 10 20 30 40 50 60 70 80 90 100
Other Latinx Black White

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sssseeeexxxxuuuuaaaalll  l   oooorrrriiiieeeennnnttttaaaattttiiiioooonnnn,,,  ,   AAAAuuuugggguuuusssstttt-- --NNNNoooovvvveeeemmmmbbbbeeeerrr  r   2222000022222222
Had at least  one dose  of the MPV  vaccine
No=5943 Yes=2608 Chi-sq p
n n Row %
Race or ethnicity 11.802 0.008
White 2907 1323 31.28%
Black 895 329 26.88%
Latinx 1419 625 30.58%
Other 659 331 33.43%
Age (M, SD) 35.65, 10.44 37.12, 10.74 35.098 0.000
Sex Identity 23.674 0.000
Cisgender male 5204 2364 31.24%
Transgender male 12 1 7.69%
Transgender female 138 30 17.86%
Non-binary, Other 589 213 26.56%
Sexual orientation 161.159 0.000
Gay, Queer 4378 2245 33.90%
Bisexual 1093 241 18.07%
Something else 472 122 20.54%
Studies included
Study Timeframe Population Methods
Porter  Novelli August  –
December  16  N= up to 371 LGBTQ+
Data  weighted  to matc  h Four  KAP surveys  in the general population
including LGBTQ+
census  population
AMETHST :Ame rican  Aug 9th  –
Transformative  HIV  15th November
Study
AMIS :American   N = 82 4 GBMSM  Emory  conducted  a one-time  KAP survey  of
Men’s Internet  2021 AMIS population.
Survey Survey  available  here
October  6 –
De
cember  31 N=3041  GBMSM
N=8,551
50% Black   and Latinx
GBMSM Monthly  cross-sectional  survey to   recruit
new  cohorts  of persons  at risk for  HIV.
Questions  related to   mpox added in   2022
August 5   –
August 15
Ongoin  g recruitment  o f the 2022  AMI  S
survey  summarized  through  12/31
 San  Fra
ncisco  study
 among p e
rsons
 experi
encing
 homelessness (PEH) Oct 23rd  –
5th  November N= 273
 5
7   wi th higher  risk sexual
activity
 35 GBMSM  Cros s-sectional  survey    among PEH to
 unde rstand  vaccine  acceptability  and
coverage

           American Men’s Internet Survey (AMIS)
 In August 2022, Emory University conducted a special one-time survey with
2021 AMIS participants to explore knowledge, attitudes and practices related to the US monkeypox outbreak.
• Also asked about behavior change and vaccination
• Survey conducted August 5-15, during the peak of the current outbreak
 Survey is available here .
 Questions ask about vaccine knowledge, access or availability, and trusted
sources of advice
 824 men completed all questionnaire sections
• Overall, 53.1% reported concern about getting mpox
• 18.6% of the sample had received at least one dose of mpox vaccine
https://www.cdc.gov/mmwr/volumes/71/wr/mm7135e1.htm

          AMIS survey results
Conducted August 5-15th2022
•18.2% of the sample had
received at least one dose ofMPOX vaccine“Equitable vaccine program implementation involve…, engaging
diverse partners already working with special populations,
delivering vaccines through mobile outreach and pop-up events, and diversifying times and locations for vaccine administration ”
“Expanding vaccine availability geographically, including diversifying vaccination locations to include nonurban areas, can help ensure that those who need vaccination have access to it .”
https://www.cdc.gov/mmwr/volumes/71/wr/mm7135e1.htm

https://www.whitehouse.gov/briefing-room/statements-releases/2022/08/30/fact-sheet-white-house-monkeypox-response-team-announces-new-plans-to-support-large-lgbtqi-events-and -
equity-interventions-to-reach-communities-at-highest-risk-of-contracting-the-virus/

 Vaccine Equity Pilot Program
Created to:
• Support innovative ways to
 15 address vaccination disparities Jurisdictions
• Encourage vaccination
coordination between health departments and community -
based organizations 28
Programs • Promote innovation to strengthen existing vaccination
infrastructure
~25k Doses

Studies included
Study Timeframe Population Methods
Four  KAP surveys  in the general  population
includin  g LGBTQ+
Emory  conducte  d a o ne-time  KAP survey  of
2021  AMIS  population  .
Survey  available  here
Ongoin  g recruitment  of the 2022  AMI  S
survey  summarized  through  12/31
Cross-sectional  survey  among  PEH t o
understand  vaccine  acceptabilit  y an  d
overage Port
er Novelli August  –
December  16  N= up to  371 LGBTQ+
Data  weighted to   match
census  population
Aug 9th  –
15th  November
AMIS :Ameri
can   August 5   –
August 15  N = 824 GBMSM
Men’s Internet
Survey
October  6 – N=3041 GBMSM
December  31
 San  Francisco  study
 amon
g persons
 exp
eriencing c
 homelessness (PEH)

  AMETH
ST:Ame rican
 Transformative  HIV
Study N=8,551
50% Blac  k and  Latinx
GBMSM Mo nthly  cross-sectional  survey  to recruit
new  cohorts  of persons  at risk for HIV .
Questions  related  to mpox added  in 2022
Oct2
3rd  –
5th  November N= 273
 5
7   wi th higher  risk  sexual
activity
 35 GBMSM

           Concern for mpox disease
AMIS 2022
 This survey has been recruiting since
October 6th 2022
 As of December 31, 2022
• 3041 cis-gender MSM have been enrolled
• 33.3% (n=1006) had received at least one
dose of mpox vaccine
 Mpox vaccination associated with
• Mpox awareness,
• Mpox concern,
• STI risk,
• and engagement in sexual health and prevention services Variable Adjusted* OR (95% CI) P value
Any mpox vaccination
HIV+ 1.66 (1.30, 2.11) <.01
High Mpox awareness 4.69 (3.94, 5.59) <.01
High Mpox concern 3.52 (2.69, 4.62) <.01
STI testing 2.57 (2.12, 3.11) <.01
Recent CAS 1.76 (1.31, 2.37) <.01
PrEP use (ever)** 7.44 (6.07, 9.13) <.01
PrEP use (past year)** 2.80 (1.40, 5.61) <.01
* Adjusted models included age group (15-20, 21-24, 25-34, 35-44,
45-59, 60+) and race/ethnicity (Hispanic, Non-Hispanic white, Non-
Hispanic Black, Other)
** PrEP models considered for people at risk for HIV acquisition
(HIV-negative)

Studies included
Study Timeframe Population Methods
Porter Novelli August –
December 16 N= up to 371 LGBTQ+
Data weighted to match
census population Four KAP surveys in the general population
including LGBTQ+
AMETHST :Ame rican
Transformative HIV
Study Aug 9th –
November 15th N=8,551 50% Black and Latinx
GBMSM Monthly cross-sectional survey to recruit
new cohorts of persons at risk for HIV.
Questions related to mpox added in 2022
AMIS :American
Men’s Internet
Survey August 5 –
August 15 N = 824 GBMSM Emory conducted a one-time KAP survey of 2021 AMIS population.
Survey available here
October 6 –
December 31 N=3041 GBMSM Ongoing recruitment of the 2022 AMIS
survey summarized through 12/31

    San Francisco study Oct 23rd – N= 273 Cross-sectional survey among PEH to
among persons November 5th 57 with higher risk sexual understand vaccine acceptability and
experiencing activity coverage
homelessness (PEH) 35 GBMSM

 Overview of San Francisco Mpox Study
 Dates: October 23 – November 5, 2022
 Project  Goals:
1
. Understand mpox vaccine
acceptability and coverage among people experiencing homelessness
2. Characterize orthopoxvirus seroprevalence among people experiencing homelessness

 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
Any higher risk
sexual activity (n=57)
GBMSM (n=35) Any higher risk
sexual activity (n=57), 56%
GBMSM (n=35), 74%
          Vaccine acceptance by subgroups at higher risk for mpox
Would accept or had accepted vaccine Unsure Would decline or had declined vaccine

 Acknowledgements
 SERMO
• Joanna Molke (SERMO)
• Ma
nsi Das (CDC)
 Porter  Novelli
• Fred Fridinger
• Christine Prue
• Guila Earle-Richardson
• Christine Agnew-Brune
• Saskia Vos
• Ciara Nestor
• Gordon Mansergh
• Deborah Gelaude
 AMIS (Emory University)
• Travis Sanchez
• Patrick Sullivan
• Marissa Hannah
• O. Winslow Edwards  AMIS (Johns Hopkins University)  AMETHST
• Stefan Baral
• Tom Carpino
• Kaitlyn Atkins
• Evan Eschliman
• Amrita Rao
• Sarah  Murray
 AMIS (CDC)
• Alexandra Oster
• Christine Agnew-Brune
• Winston Abara
• Neal Carnes
• Rachel Kachur
• Kaytlin Renfro
• Elizabeth DiNenno
• Amy Lansky
• Kathleen Ethier • Christian Grov
• Adam Carrico
• Denis Nash
• Drew Westmoreland
• Viraj Patel
• Tyler Bartholomew
• Jennifer Manuzak
• Dustin Duncan
• Kathryn McCollister
• Meredith Ray
• Matthew Stief
• Alexa D’ Angelo
• Chloe Mirzayi
• Michelle Dearolf
• Sarah Kulkarni
• Alyse Johnson
• Leah Davis Ewart
• Yan Guo
 CDC 2022 Multinational Mpox
Outbreak Response Community Engagement Taskforce

Summary: x Information on Mpox vaccine acceptability and uptake from cross- sectional surveys  Kevin P . Delaney, PhD, MPH  Community Engagement and Vaccine Policy and Implementation Task Force 2022 Multinational Mpox Response Centers for Disease Control and Prevention  Advisory Committee on Immunization Practices  February 22, 2023  www.cdc.gov/mpo  Information from US-based Clinicians   Sermo – online community of >1.3 million clinicians   Conducted a worldwide survey of physicians  July 31-August…