National Center for Emerging and Zoonotic Infectious Diseases

Clinical guidance and next stepsAdvisory Committee on Immunization PracticesOctober 25, 2023Agam Rao, MDCAPT, US Public Health ServicePoxvirus and Rabies BranchCenters for Disease Control and Prevention
Guidance about vaccination before exposure

 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 pe

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 geographic 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 vaccine associa– However, animal models including in rats have shown no evide

the developing fetus

– No adverse events reported via vaccine safety surveillance syst

 Safety in breastfeeding persons 

– Has not been evaluated– No adverse events reported via vaccine safety surveillance syst

 JYNNEOS is not contraindicated in pregnancy or while breastfeedin Pregnant or breastfeeding persons at risk for mpox* may receive th

vaccine before an exposure

*See slide 2 for description of population at risk for mpox
Healthcare personnel

 Healthcare-associated mpox infections have been rare, ty

associated with sharps injuries or exposure in the absence protective equipment

 Healthcare personnel at risk for mpox because of the risk 

described (e.g., MSM with more than one sexual partner) vaccinated; however, this recommendation is not because occupational risk

 JYNNEOS is not recommended as a routine vaccination fo

personnel unless sexual risk factors are present
Myopericarditis

 Known risk after ACAM2000, a different orthopoxvirus vaccine; mec

unknown so theoretical risk with JYNNEOS has not been ruled out

 Known risk after COVID-19 vaccines, particularly in adolescent and y

males

 CDC websites for COVID-19 and mpox vaccines provide interim guid

coadministration
CDC guidance for coadministration of JYNNEO

COVID-19 vaccines There is no required minimum interval between receiving an

vaccine and JYNNEOS vaccine (e.g., for mpox prevention), regwhich vaccine is administered first

 People, particularly adolescent and young adult males, who 

recommended to receive both vaccines might consider waitibetween vaccines. This is because of the observed risk for mpericarditis after receipt of ACAM2000 orthopoxvirus vaccine 19 vaccines and the hypothetical risk for myocarditis and perJYNNEOS vaccine. However, if a patient’s risk for mpox or sedue to COVID-19 is increased, administration of JYNNEOS anvaccines should not be delayed 

https://www.cdc.gov/vaccines/covid-19/clinical-considerations/interim-considerations-us.html
Clinical guidance when JYNNEOS and immun

products are temporally administered  Most immunoglobulin products: No precautions are necessa

is administered in close temporal proximity to Intravenous im(IVIG)

 Vaccinia immune globulin intravenous (VIGIV)

– Could interfere with immune response to JYNNEOS

• Ideally, administration of JYNNEOS should be delayed if VIGIV was rece• The duration for which it should be delayed is unknown; public health 

should be obtained for case specific guidance 

– Unlikely that VIGIV would be administered in close proximity to 
Contraindications and precautions

 JYNNEOS was licensed* for prevention of smallpox in additio

prevention of mpox

 Because smallpox is nearly always life-threatening, there are 

contraindications; however, for mpox, considerations may be 

 Consistent with contraindications in ACIP routine schedules, W

– JYNNEOS contraindicated in patients with a severe allergic reac

anaphylaxis) after a previous dose or to a vaccine component

– Precautions: Moderate or severe acute illness, with or without 

*https://www.fda.gov/media/131078/download
Other administration guidance

 Completion of the 2-dose series should be encouraged As much as possible, the 2nd dose of JYNNEOS should be adm

days after the first dose

 Unintentional delays in receiving the 2nd dose does not requi

the series; the second dose should be administered as soon aeven if >1 year has elapsed
Next steps
Tentative timeline for ACIP discussions and v

Interim routinerecommendation 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 existing recommendations for the current mpox outbreak. § https://www.cdc.gov/poxvirus/monkeypox/interim-considerations/overview.html
Proposed recommendation is interim 

recommendation If passed, recommendations will be revisited in 2-3 years  Epidemiology at the time may inform decision about continu

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.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.

National Center for Emerging and Zoonotic Infectious DiseasesDivision of High-Consequence Pathogens and Pathology

Questions?