National Center for Emerging and Zoonotic Infectious Diseases

Mpox Vaccine Work Group

ACIP MeetingFebruary 22, 2023Pablo Sanchez MDThe Ohio State University−Na/onwide Children’s HoChair, ACIP Mpox Work Group
Mpox – Historical Context

 Rare, sometimes life-threatening infection Endemic in parts of west and central Africa Caused by monkeypox virus (which is an orthopoxvirus)

– Clade I (previously Congo Basin Clade)– Clade II (previously West African Clade)

 Can spread from infected animals to people and then person

– Respiratory secretions – Skin-to-skin contact with infected bodily fluids (e.g., fluid from – Fomites (e.g., shared towels, clothing, and bedding)
Timeline of Notable Human Mpox Events*

-First human case identified-Rural settings

1970 2017 2018 2019

Imported cases to UK and Israel: 3

Imported cases to USingapore

Outbreak in Nigeria involving 17 states: 138 cases

US outbreak from pet prairie dogs (cohoused with infected small mammals from Ghana): 47 cases

2003

*During 1970-2021, mpox was known to be endemic in 9 African countries: Cameroon, Centr

Cote d’Ivoire, Democratic Republic of Congo, Gabon, Liberia, Nigeria, Republic of Congo, and 

recent years, there has been a re-emergence of human cases after decades of no reported ca
Person-to-person spread

 Historical outbreaks in Africa

– Associated with close skin-to-skin contact and contact with – Zoonotic exposure cause of most cases– Few secondary cases among close contacts (e.g., househo

 US outbreaks

– 2003: No secondary cases 

 no vaccinations offered

– 2021: No secondary cases 

 ACAM2000 offered to some 

– 2022: Many secondary cases 

>1 million doses of JYNNE

*ACAM2000 was offered through a CDC Investigational New Drug Protocol that allows for vaccination after mpox exrisk exposures were offered vaccine; none accepted.
2021 ACIP Orthopoxvirus Vaccine Vote

 Use of orthopoxvirus vaccine, JYNNEOS, (licensed in 2019) fo

vaccination of people at occupational risk for orthopoxvirus e

 2-dose series, subcutaneous administration Recommendations published June 3, 2022*

*https://www.cdc.gov/mmwr/volumes/71/wr/mm
Currently no ACIP recommendation for use of JY

during outbreaks
Current U.S. national mpox vaccination strate

*https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html

Vaccination before exposure to 

mpox virus

Post-exposure p

-Gay, bisexual, and other MSM, transgender or nonbinary people (including adolescents who fall into the aforementioned categories) who in the past 6 months have had:• New diagnosis of 

≥ 1 sexually transmitted disease

• More than one sex partner-People with the following in the last 6 months:• Sex at commercial sex venue• Sex in association with large public event in 

geographic area where mpox transmission is occurring

-Sexual partners of people with the above risks-People who anticipate experiencing above risks-People with HIV or other causes of immunosuppression who have had recent or anticipate potential mpox exposure

-People who are known conwith mpox and identified by authorities (for example, via contact tracing, or risk expo-People who are aware that partner within the past 14 dwith mpox-Gay, bisexual, or other MSMor nonbinary people (includwho fall into any of the aforecategories) who have had awithin the past 14 days: sex partners (or group sex); sex venue; or sex in association venue, or defined geographtransmission is occurring
U.S. strategy for vaccination with JYNNEOS d

current outbreak  Intradermal preferred but subcutaneous can be administered 

aged ≥ 18 years

 Subcutaneous for persons aged <18 years* 2-dose series with second dose administered 1 month after f

*https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html
Tentative timeline for ACIP discussions and v

Mpox outbreaks: Use of 2-dose JYNNEOS for persons aged ≥ 18 years

February 2023 June 2023 Oc

Mpox outbreaks: Use of 2-dose JYNNEOSfor persons aged <18 years -Updates about vaccine effectiveness and safety

Consider vaccinatJYNNEOS

*February 2023 and June 2023 votes do not impact existing recommendations for the current mpox outbreak. § https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html
Tentative timeline for ACIP discussions and v

Mpox outbreaks: Use of 2-dose JYNNEOS for persons aged ≥ 18 years

February 2023 June 2023 Oc

Mpox outbreaks: Use of 2-dose JYNNEOSfor persons aged <18 years -Updates about vaccine effectiveness and safety

Consider vaccinatJYNNEOS

Current U.S. mpox vaccination strategy remains in effect

Current US mpox vaccination strategy remains active: Popula

at high risk should continue to be vaccinated

§

*February 2023 and June 2023 votes do not impact existing recommendations for the current mpox outbreak. § https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html
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 

– Evidence to recommendations (EtR) framework: Agam Rao– ACIP vote
Proposed wording for today’s vote

ACIP recommends the 2-dose* JYNNEOS vaccine series for persoaged 18 years and older at risk of mpox during an mpox outbrea

*Dose 2 administered one month after dose 1§ Public health authorities determine whether there is an mpox outbreak; a single case ma

an mpox outbreak at the discretion of public health authorities. Other circumstances in w

health response may be indicated include ongoing risk of introduction of mpox into a comdisease activity in another geographic area.
WG members

ACIP MemberPablo SánchezBeth Bell Ex Officio and Liaison MembersCSTE: Chris Hahn / Paul Cieslak

ASTHO: Ericka McGowan

NACHO: Philip HuangFDA: Sixun Yang, Clement 

Meseda & Alonzo García

ACOG: Howard MinkoffAAP: Jim Campbell

AIM: Rob Schechter / Jane APHL: Jafar Razeq

NIH: Janet Lathey / KimberIHS: Matthew ClarkNACI: Nicole Forbes / OliveIDSA: Shireesha Dhaniredd

Invited ConsultantsSubject matter experts: IngIsaacs, Mike Merchlinsky & 

Zarrabian (HHS/BARDA)

Clinician experts in STIs, HImaternal vaccination, vaccequity, smallpox vaccinatiooccupational health
Clinician experts

STIs, HIV, and mpox(adult and peds):

Jason ZuckerJeanne Marrazzo

Pablo TebasVince MarconiKim WorkowskiBonnie Maldonado

Immunizations (including for special populations) and vaccine safety:Ruth KarronFlor Munoz-RivasKathy Edwards

Health equity, vaccination including for smallpox:

Joel Breman

Gerard Vong

Occupational Medicine anMark Russi
CDC contributors

Mpox epi, lab, and vaccine expertsBrett Petersen

Andrea McCollum

Christy HutsonLaboratory Response Network:

Julie Villanueva

Infection control, worker safety:Marie de PerioDavid KuharSpecial populations (e.g., Persons experiencing homelessness)Emily Mosites

Vaccine safetyMichael McNeil

Jonathan Duffy

Regulatory AffairsYon YuSTIs and HIVLaura BachmannLeandro Mena

John Brooks Alexa Oster

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For more information, contact CDC

1-800-CDC-INFO (232-4636)TTY: 1-888-232-6348 www.cdc.govThe 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!