Document text
National Center for Emerging and Zoonotic Infectiou s Diseases
Mpox Vaccine Work Group: Introduction
ACIP Meeting October 25, 2023 Pablo Sanchez MD /uni00YJhe Ohio State /uni00YYni/uni00-6ersit/uni00-9/uni2212Na/gJ1Yon/uni00--ide Children/uni2019s /uni00J8osp ital
Chair, ACIP Mpox Work Group
Global mpox outbreak, 2022
First case in this outbreak identified in the Unite d Kingdom in May 2022
Primarily affecting gay, bisexual, and other men wh o have sex with men
(MSM)
Associated with person-to-person spread via close s kin-to-skin contact
including sex
Deaths have occurred, primarily among persons with severe
immunocompromise from advanced HIV
U.S. case counts and deaths comprising 1/3 of cases and deaths
–>30,800 cases
–54 deaths
Current global cases reported to WHO, September, 2023
https://worldhealthorg.shinyapps.io/mpx_global/
JYNNEOS
Comprised of replication-deficient vaccinia virus
Administered subcutaneously* via 2 vaccine doses, 28 day s apart
Effectiveness assessed by comparing immunologic response to that for
ACAM2000
Licensed for prevention of both smallpox and mpox
Is recommended for persons with HIV and other immunoc ompromising
conditions
Licensed for persons ≥ 18 years of age; an NIH trial is underway to evaluate
safety and immunogenicity for persons 12-17 years of a ge
*During the 2022 mpox outbreak, it was also administ ered intradermally because of limited vaccine avail ability; it is currently available
in enough supply
Outbreak recommendation: February and June ACIP meetings
Vote: ACIP recommends the 2-dose* JYNNEOS vaccine s eries 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 i s an mpox outbreak; a single case may be considered an
mpox outbreak at the discretion of public health aut horities. Other circumstances in which a public hea lth
response may be indicated including ongoing risk of introduction of mpox into a community due to diseas e
activity in another geographic area
Outbreak recommendations intended for any U.S. mpox outbreak,
regardless of whether associated with male-to-male sexual contact
Clinical guidance, including about use of vaccine i n children during
outbreaks discussed
National mpox vaccination strategy for pre-exposure
vaccination during current outbreak*
*https://www.cdc.gov/poxvirus/monkeypox/interim-con siderations/overview.html Vaccination before exposure to mpox virus
-Gay, bisexual, and other MSM, transgender or nonbi nary 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 geogr aphic 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 immunosuppressi on who have had recent or
anticipate potential mpox exposure
Elimination of human-to-human transmission
WHO strategy in development; additional resources a nd data needed
Immunization may be one component of the strategy
Elimination is a complex issue not addressed by WG; however, a
recommendation that persons at-risk for mpox during the ongoing
outbreak receive the vaccines if they have not alre ady, may support any
upcoming WHO strategy
Recommendation that will be proposed during today’s
meeting
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 18 years and older at risk for mpox §?
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
•Gay, bisexual, and other men who have sex with men, transgender or nonbinary people who
in the past 6 months have had one of the following:
•A new diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
•Sex at a commercial sex venue
•Sex in association with a large public event in a g eographic area where mpox
transmission is occurring
•Sexual partners of persons with the risks described in above
•Persons who anticipate experiencing any of the abov e
Potential implications of interim routine recommendation
Increase vaccine coverage and prevent or minimize o utbreaks
Remove some stigma and facilitate 1:1 consultation with clinician during
appointments
Potential commercialization of JYNNEOS
Product sponsor (Bavarian Nordic) has indicated they will attempt to
commercialize the vaccine if it is on a routine schedule
This will transition vaccine from U.S. government stockpiles (which were
intended for smallpox preparedness) to the commercial se ctor
Tentative timeline for ACIP discussions and votes*
Interim routine recommendation and clinical guidance
October 2023 Early 2024 Possibly 2024 Publication of 2 MMWRs: 1) Use of JYNNEOS during mpox
outbreaks
2) Use of JYNNEOS among
persons at risk during the ongoing mpox outbreak Consider results from NIH trial about use of JYNNEOS in persons aged 12-18 years
*February 2023 and June 2023 votes do not impact ex isting recommendations for the current mpox outbrea k.
8uni0067https://www.cdc.gov/poxvirus/monkeypox/interim-cons iderations/overview.html TBD Review epidemiology, cost-effectiveness analysis, and other data to determine if routine recommendation should be continued
Proposed recommendation
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 18 years and older at risk for mpox §?
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
•Gay, bisexual, and other men who have sex with men, transgender or nonbinary people who
in the past 6 months have had one of the following:
•A new diagnosis of ≥ 1 sexually transmitted disease
•More than one sex partner
•Sex at a commercial sex venue
•Sex in association with a large public event in a g eographic area where mpox
transmission is occurring
•Sexual partners of persons with the risks described in above
•Persons who anticipate experiencing any of the abov e
Goal for today’s meeting
Updates from the ongoing outbreak
–Epidemiology: Dr. Faisal Minhaj
–Evidence to recommendations framework: Dr. Agam Ra o
–Clinical guidance and next steps: Dr. Agam Rao
Vote
–Mpox vote
–Mpox Vaccines for Children vote
WG members
ACIP Member
Pablo Sánchez Beth Bell
Ex Officio and Liaison Members
CSTE: Chris Hahn / Paul Cieslak
ASTHO: Ericka McGowan
NACHO: Philip Huang FDA: Sixun Yang, Clement
Meseda & Alonzo García
ACOG: Howard Minkoff AAP: Jim Campbell
HRSA: Vikram Krishnasamy AIM: Rob Schechter / Jane Zucker APHL: Jafar Razeq
NIH: Janet Lathey / Kimberly Taylor IHS: Matthew Clark NACI: Nicole Forbes / Joshua Montroy IDSA: Shireesha Dhanireddy / Rajesh Gandhi
Invited Consultants
Subject matter experts: Inger Damon, Stuart 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
Pablo Tebas Vince Marconi Kim Workowski Bonnie Maldonado
Immunizations (including for special
populations) and vaccine safety:
Ruth Karron Flor Munoz-Rivas Kathy Edwards Health equity, vaccination strategies
including for smallpox:
Joel Breman
Gerard Vong
Occupational Medicine and worker safety:
Mark Russi
CDC contributors
Mpox epi, lab, and vaccine experts
Andrea McCollum
Christy Hutson Sathesh Panayampalli
Infection control, worker safety:
Marie de Perio David Kuhar Vaccine safety
Jonathan Duffy
Michael McNeil Regulatory Affairs
Yon Yu
STIs and HIV
Laura Bachmann Leandro Mena
John Brooks Alexa Oster Drug Services
Julian Jolly
Vaccine
implementation
Laura Daniel
James Lee
DoD Liaison to CDC
Alan Lam
Work group lead
Agam Rao
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 tho se of the authors and do not necessarily represent the
official position of the Centers for Disease Contro l and Prevention. Thank you!