Document text
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.