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Agency for Toxic Substances and Disease Registry National Center for Environmental Health
Centers for Disease Control and Prevention
Mpox Vaccine Work Group
Faisal Syed Minhaj, PharmD, MPH Poxvirus and Rabies Branch Centers for Disease Control and Prevention
ACIP Meeting April 15, 2025
•Genus: Orthopoxvirus
•Family: Poxviridae
•Discovered in 1958 after two pox-like disease outbreaks in research monkey colonies
•Specific animal reservoir unknown, but likely African small mammals
•On November 28, 2022, WHO implemented the preferred term “mpox” for the disease
•Two clades of MPXV:
-Clade I: found in central Africa and historically associated with greater disease severity in a higher proportion of people
-Clade II: found in West Africa and caused the 2022 global outbreak Monkeypox virus (MPXV)
Mpox historical context
Mpox historical context
Mpox historical context
Mpox historical context
Mpox historical context
• 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 comprise 1/3 of cases a nd deaths globally
- >30,000 cases
- >60 deaths Global Mpox Outbreak, 2022
United States mpox case count and 7-day moving Average – May 2022 through March 2025
Peak Confirmed Daily Cases (7-day average): 467 cases
Date
United States mpox case count and 7-day moving Average – August 2024 through March 2025
Subject to reporting delays
The currentmedian 7-
daymovingaverage for confirmedcases for February is 3.3-1.2per day.
•ACIP recommends the 2-dose* JYNNEOS vaccine series fo r persons aged 18
years and older at risk of mpox during an mpox outbrea k §.
*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 t he discretion of public
health authorities. Other circumstances in which a public health response may
be indicated include ongoing risk of introduction o f mpox into a community
due to disease activity in another geographic area.Current Recommendation (voted February 2023)
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 18 years and older at risk for mpox §?Current Recommendation (voted October 2023) –updated language
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
1. Gay, bisexual, and other men who have sex with m en (MSM), or a person who has sex with
MSM who in the past 6 months have had one of the follow ing:
•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
2. Sexual partners of persons with the risks descri bed in above
3. Persons who anticipate experiencing any of the a bove
Mpox current situation
•Modeling data suggests any increase in coverage reduces the risk of
outbreaks, and low coverage (<50%) could promote la rger outbreaks Jynneos vaccine coverage in the United States among people
at risk for mpox – June 2022 to September 2024
Overall vaccine coverage
1-dose: 42.2% and 2-dose: 26.2 %
U.S. mpox case trends in adolescents and pediatrics ,
May 2022 – March 2025
Case
Count Age
group
92 12-17
17 6-11
23 1-5
15 <1
147 Total
Subject to reporting delays
•Previously, there was no data evaluating Jynneos in childr en <18 years
•An NIH sponsored trial completed last year evaluating Jyn neos in 12–17-
year-old adolescents
-DMID 22-0020: A Phase 2 Randomized, Open-Label Mult isite Trial to Inform
Public Health Strategies Involving Use of MVA-BN Va ccine for Mpox (DoSES)
•Stage 2: non-inferiority trial of Jynneos in adoles cents compared to adults
•Proposed recommendations would extend current recommendations to
12–17-year-old adolescents New data on safety and immunogenicity in adolescents
•ACIP recommends the 2-dose* JYNNEOS vaccine series fo r persons 12–17
years of age 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 t he discretion of public
health authorities. Other circumstances in which a public health response may
be indicated include ongoing risk of introduction o f mpox into a community
due to disease activity in another geographic area.Proposed Recommendation 1
ACIP recommends vaccination* with the 2-dose †JYNNEOS vaccine series for
persons aged 12–17 years at risk for mpox §?Proposed Recommendation 2
*Interim recommendation to be revisited in 2-3 year s
† Dose 2 administered 28 days after dose 1
§Persons at risk:
1. Gay, bisexual, and other men who have sex with m en (MSM), or a person who has sex with
MSM who in the past 6 months have had one of the fo llowing:
•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
2. Sexual partners of persons with the risks descri bed in above
3. Persons who anticipate experiencing any of the a bove
•Presentation of the safety and immunogenicity of Jynneo s in 12–17-year-
olds: Dr. C. Buddy Creech
•Evidence to recommendations framework:
-Outbreak recommendations: Dr. Faisal Minhaj
-Routine recommendations: Dr. Faisal Minhaj Goals for today’s meeting
Tentative timeline for ACIP discussions and votes
ACIP Meeting:
Presentation
of two EtR
April 2025 ACIP Meeting:
Voting on two
EtR
June 2025 Continue monitoring
mpox epidemiology
and vaccine
recommendations
Ongoing
•WG Chair
-Yvonne (Bonnie) Maldonado
•WG Lead
-Faisal Syed Minhaj
•ACIP Members
-Edwin Asturias
-Lin Chen
•Ex Officio/Liaison members
-CSTE: Paul Cieslak
-ASTHO: Chris Taylor
-NACHO: Philip Huang
-FDA: Sixun Yang, Pete Weina
-ACOG: Howard Minkoff
-AAP: Jim Campbell WG Composition
•Ex Officio/Liaison members (cont.)
-HRSA: Vikram Krishnasamy
-AIM: Heather Roth
-NIH: Kimberly Taylor
-IHS: Uzo Chukwama
-NACI: Nicole Forbes, Joshua Montroy
-IDSA: Shireesha Dhanireddy, Katherine Hsu
•Invited Consultants
-Inger Damon
-Stuart Isaacs
-Mike Merchlinsky
-Amanda Zarrabian •Clinician experts
STIs, HIV, mpox, pediatrics
-Jason Zucker
-Kim Workowski
-Pablo Sánchez
-Beth Bell
Immunization
-Ruth Karron
-Flor Munoz-Rivas
CDC Contributors
•Mpox Epi/Lab/Vaccine experts
-Agam Rao
-Andrea McCollum
-Christina Hutson
-Sathesh Panayampalli
-Shama Cash-Goldwasser
•Vaccine Safety
-Michael McNeil
-Jonathan Duffy •Regulatory Affairs
-Yon Yu
•STIs and HIV
-Laura Bachman
-Jesse O’Shea
•Drug Services
-Julian Jolly
•Vaccine Implementation
-Liz Velazquez
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 Control and Pre vention.
Thank you