04 MPOX Rao 508

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National Center for Emerging and Zoonotic Infectiou s Diseases 
Clinical guidance and next steps 
Advisory Committee on Immunization Practices October 25, 2023 Agam Rao, MD CAPT, US Public Health Service Poxvirus and Rabies Branch Centers for Disease Control and Prevention 
Guidance about vaccination before exposures to mpox
Similar to what has previously been presented to ACIP 
Specific to pre-exposure vaccination 
Specific to the population 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 
Persons <18 years of age at risk for mpox 
JYNNEOS is not licensed for persons <18 years of age 
No pre-licensure studies in this population; however, no safety signals identified during the current outbreak 
NIH clinical trial in progress:  Safety and immunogenicity of JYNNEOS in persons aged 12-17 years 
Adolescents at risk for mpox* may receive the JYNNEOS vaccine before an exposure 
*See slide 2 for description of population at risk for mpox 
Pregnant or breastfeeding persons 
Pregnancy 
–Available human data insufficient to determine vacc ine associated risks 
–However, animal models including in rats have shown  no evidence of harm to 
the developing fetus 
–No adverse events reported via vaccine safety surve illance systems 
Safety in breastfeeding persons 
–Has not been evaluated 
–No adverse events reported via vaccine safety surve illance systems 
JYNNEOS is not contraindicated in pregnancy or whil e breastfeeding 
Pregnant or breastfeeding persons at risk for mpox*  may receive the JYNNEOS 
vaccine before an exposure 
*See slide 2 for description of population at risk for mpox 
Healthcare personnel 
Healthcare-associated mpox infections have been rare , typically 
associated with sharps injuries or exposure in the absence of personal 
protective equipment 
Healthcare personnel at risk for mpox because of the  risk factors 
described (e.g., MSM with more than one sexual part ner) should be 
vaccinated; however, this recommendation is not bec ause of 
occupational risk 
JYNNEOS is not recommended as a routine vaccination  for healthcare 
personnel unless sexual risk factors are present 

Myopericarditis 
Known risk after ACAM2000, a different orthopoxviru s vaccine; mechanism 
unknown so theoretical risk with JYNNEOS has not be en ruled out 
Known risk after COVID-19 vaccines, particularly in  adolescent and young adult 
males 
CDC websites for COVID-19 and mpox vaccines provide interim guidance for 
coadministration 
CDC guidance for coadministration of JYNNEOS with COVID-19 vaccines 
There is no required minimum interval between recei ving any COVID-19 
vaccine and JYNNEOS vaccine (e.g., for mpox prevent ion), regardless of 
which vaccine is administered first 
People, particularly adolescent and young adult mal es, who are 
recommended to receive both vaccines might consider  waiting 4 weeks 
between vaccines. This is because of the observed r isk for myocarditis and 
pericarditis after receipt of ACAM2000 orthopoxviru s vaccine and COVID-
19 vaccines and the hypothetical risk for myocardit is and pericarditis after 
JYNNEOS vaccine. However, if a patient’s risk for mp ox or severe disease 
due to COVID-19 is increased, administration of JYN NEOS and COVID-19 
vaccines should not be delayed 
https://www.cdc.gov/vaccines/covid-19/clinical-cons iderations/interim-considerations-us.html 
Clinical guidance when JYNNEOS and immunoglobulin products are temporally administered 
Most immunoglobulin products: No precautions are necessa ry if JYNNEOS 
is administered in close temporal proximity to Intravenous immunoglobulin 
(IVIG) 
Vaccinia immune globulin intravenous (VIGIV) 
–Could interfere with immune response to JYNNEOS 
•Ideally, administration of JYNNEOS should be delayed  if VIGIV was recently administered 
•The duration for which it should be delayed is unkn own; public health consultation 
should be obtained for case specific guidance 
–Unlikely that VIGIV would be administered in close proximity to JYNNEOS 
Contraindications and precautions 
JYNNEOS was licensed* for prevention of smallpox in addition to 
prevention of mpox 
Because smallpox is nearly always life-threatening, there are no absolute 
contraindications; however, for mpox, considerations  may be different 
Consistent with contraindications in ACIP routine s chedules, WG proposed 
–JYNNEOS contraindicated in patients with a severe a llergic reaction (e.g., 
anaphylaxis) after a previous dose or to a vaccine component 
–Precautions: Moderate or severe acute illness, with or without fever 
*https://www.fda.gov/media/131078/download 
Other administration guidance 
Completion of the 2-dose series should be encouraged 
As much as possible, the 2 nd dose of JYNNEOS should be administered ~28 
days after the first dose 
Unintentional delays in receiving the 2 nd dose does not require restarting 
the series; the second dose should be administered as s oon as possible 
even if >1 year has elapsed 
Next steps 
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. 
JuniYYT7https://www.cdc.gov/poxvirus/monkeypox/interim-cons iderations/overview.html ~2025/2026 Review epidemiology, cost-effectiveness analysis, and other data to determine if routine recommendation should be continued 
Proposed recommendation is interim recommendation 
If passed, recommendations will be revisited in 2-3 years 
Epidemiology at the time may inform decision about continuin g routine 
vaccinations 
Vaccine may be commercialized by that time 
Cost-effectiveness analysis will be performed 
Acknowledgements 
ACIP Work Group 
Howard Minkoff 
Jane Zucker 
Jim Campbell 
Sathesh Panayampalli 
Alli Tuttle 
Jonathan Duffy 
Rosalind Carter 
Neil Murthy 
Patricia Wodi Mark Russi 
Marie de Perio 
Jason Zucker 
John Brooks 
David Kuhar 
Evelyn Twentyman 
Sara Oliver 
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. 
National Center for Emerging and Zoonotic Infectiou s Diseases 
Division of High-Consequence Pathogens and Patholog y Questions?