Document text
National Center for Emerging and Zoonotic Infectiou s Diseases
Evidence to Recommendations Framework: Vaccination with JYNNEOS for Persons At Risk of Mpo x
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
Evidence to Recommendations (EtR) Framework
Structure to describe information considered in moving fr om evidence to
ACIP vaccine recommendations
Provides transparency around the impact of additional fa ctors on
deliberations when considering a recommendation
EtR question
Does ACIP recommend vaccination with the 2-dose* JYN NEOS vaccine series
for persons aged 18 years and older at risk †for mpox?
*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 above
Policy question: Should the 2 dose JYNNEOS vaccine s eries* be recommended
for persons aged 18 years and older at risk †for mpox ?
Population Persons aged 18 years and older at risk for mpox
Intervention Vaccination with JYNNEOS®
Comparison No vaccination
Outcome a) Prevention of disease
b) Severity of disease
c) Serious adverse events d) Myo-/ peri- carditis
*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 above
EtR Domains
EtR Domain Question(s) Public Health Problem •Is the problem of public health importance?
Benefits and Harms •How substantial are the desirable anticipated effec ts?
•How substantial are the undesirable anticipated eff ects?
•Do the desirable effects outweigh the undesirable e ffects?
Values •Does the target population feel the desirable effec ts are large relative to the undesirable
effects?
•Is there important variability in how patients valu e the outcome?
Acceptability •Is the intervention acceptable to key stakeholders?
Equity •What would be the impact of the intervention on hea lth equity?
Feasibility •Is the intervention feasible to implement?
Resource Use •Is the intervention a reasonable and efficient allo cation of resources?
Public Health Problem
Are continued mpox cases of public health importance?
>1.25 million doses of JYNNEOS have been administered in t he United States
However, national vaccine coverage remains lower than ide al, possibly
because of lower perceived risk in the last 6 months
Mpox cases continue to occur domestically and internation ally, including in
clusters
Modeling data suggests larger outbreaks may occur if va ccine coverage
remains <50% nationally for persons at risk of mpox
Severe disease and deaths continue to occur
Benefits and Harms
Main source of VE data has been three U.S. studies
CDC EPIC study
CDC Multi-jurisdictional study
New York State study
Estimated VE for preventing mpox disease has ranged from 66-89% for the 2-dose vaccine series
Multi-jurisdictional study: estimate of VE for preventing infections among immunocompetent vs. self-reported immunocompromised persons
*Adjusted for age, race/ethnicity, immunocompromise d status, reported close contact with a
confirmed/suspected mpox case in 3 weeks prior to i ndex event
•Only recently able to evaluate VE of self-reported immunocompromised, confidence interval is still wid e
•Modifications in protocol needed to evaluate VE for objectively confirmed immunocompromised persons
How substantial are desirable anticipated effects o f
JYNNEOS?
ACIP previously recommended use of JYNNEOS
–Persons at increased risk of occupational exposure to orthopoxviruses
–Persons at-risk for mpox during mpox outbreaks
Subsequent data has supported its effectiveness for the population
impacted by the ongoing outbreak
How substantial are desirable anticipated effects o f
JYNNEOS?
ACIP previously recommended use of JYNNEOS
–Persons at increased risk of occupational exposure to orthopoxviruses
–Persons at-risk for mpox during mpox outbreaks
No new safety signals identified from pre-licensure studies
The adverse events most commonly reported to VAERS have been
injection site symptoms (redness, swelling, pain, i tching)
Balance between desirable effects relative to undesirable effects of JYNNEOS
Desirable anticipated effects considered large
Undesirable anticipated effects considered small Do the desirable effects outweigh the undesirable e ffects?
Favors intervention Favors comparison Favors both Favors neither Unclear
EtR Domain: Values
Early in outbreak response: National surveys indica ted
strong interest in vaccine
During Aug-Nov 2022, >85% of respondents in the Ame rican
Transformative HIV Study (AMETHST) were interested in vaccine, and
uptake doubled from August to September
During August-Dec 2022, 50% of Porter-Novelli survey responders who
identified as LGBTQ+ felt the vaccination is import ant to protect from mpox
During Oct-Nov 2022, >70% of MSM in a San Francisco survey of persons
experiencing homelessness reported that they would accept or have
accepted vaccination
During October-December 2022, an American Men’s Int erest Survey
(AMIS) showed that those who were concerned about m pox were 3.5x
more likely to be vaccinated
https://grants.nih.gov/grants/guide/rfa-files/RFA-A I-21-018.html
https://emoryamis.org/wp-content/uploads/2022/08/20 22-Monkeypox-Survey.pdf
https://www.cdc.gov/mmwr/volumes/71/wr/mm7135e1.htm
Filardo TD. Vaccine. 2023 Sep 7;41(39):5673-5677.
Early in outbreak: Persons seeking vaccination were ,
as expected, supportive of the JYNNEOS vaccine
DC PEP ++ Study: CDC and DC Health collaboration to follo w cohort of
persons at elevated risk of mpox exposure in Washington D.C. who
presented for JYNNEOS vaccination, Aug 2022-Oct 2022
–Survey with 866 adults
–>85% agreed or strongly agreed that vaccines for mp ox should be available to
anyone who wants the vaccine
–82% were likely or very likely to get a third dose if it was recommended
Qualitative interviews August and September 2022 am ong adults
presenting for JYNNEOS vaccine in Washington DC
–Many participants grateful that LGBTQ+ were given p riority vaccine access
(suggests interest in vaccine)
Hassan, R. (in press). Sexually Transmitted Diseases
Early in outbreak: Studies indicated conflicting fe elings
about receiving JYNNEOS vaccines
Curtis et al. Survey with 320 persons, primarily MS M living in Illinois and at
risk for mpox. September 2022
–24.1% received 2 vaccine doses, 27.5% received one dose, 47.5% no doses
–Persons who were vaccinated were more likely to hav e higher education, know
someone with mpox, express concern about their safe ty, and less likely to
report recent food insecurity
Turpin et al. Qualitative interviews with 24 Black MSM attending HIV
prevention-related events in greater D.C. area, May 2022
–Lack of availability of mpox vaccines was common co ncern suggesting interest
–Vaccine hesitancy was also common
https://pubmed.ncbi.nlm.nih.gov/37236817/
https://pubmed.ncbi.nlm.nih.gov/37510557/
More recent: State of vaccine confidence report, J une
2023
Review of mpox-related discussions on 23 news and social media outlets in the Chicago area during the
month following the CDPH media release indicating a n
increase in mpox cases, particularly among previous ly
vaccinated persons
Findings:
–Mpox vaccine hesitancy among general public and LGB TQ-
affiliated groups noted
–Questions raised
•Effectiveness and safety of the vaccine (e.g., sent iment expressed
that vaccine is experimental)
•Distrust in reporting (e.g., Suspicion that mpox re porting is
exaggerated)
https://www.cdc.gov/vaccines/covid-19/downloads/SoV C-MPOX-062723.pdf
More recent: Interviews with 18 patients associated
with mpox cluster in Chicago, May 2023
Fully vaccinated, partially vaccinated, unvaccinated intervie wed
Most stated they would recommend vaccine to others
Most vaccinated persons felt vaccine was effective in re ducing severity
Some assumed it would prevent infection
Unvaccinated reported initial interest in vaccine when supp ly was limited
and they were unable to receive it; they reported they did not seek it again
because case counts decreased so they assumed diminish ed risk
More recent: Online focus group used by CDC to develop communication material, July 12, 2023
Session conducted with 52 persons
–Participant inclusion criteria:
•Identify as men (including transgender men and tran sgender women)
•Unvaccinated for mpox and never diagnosed with mpox
•18-45 years of age
•Sex with 2 or more men within past 6 months
–Participant demographics: average age 30-34 years; 48% Black, 37% White, 27%
Hispanic/Latino; 75% gay, 21% bisexual
Exposure to communication materials increased intere st in receiving mpox vaccine
–Information about mpox vaccine safety, effectiveness , and current threat of mpox
affected interest
–Current risk of mpox and protecting community were m otivating
Some people did not change their minds
Target population sentiments
Vaccine demand was high early in the outbreak response
National surveys with the affected population indicate ove rall interest in
JYNNEOS vaccinations
Target population sentiments
Interest and intent to get vaccinated varies among the affected population
Lower perceived risk of mpox may contribute to reduced interest in vaccine
later in the outbreak
EtR Domain: Acceptability
Stakeholder perceptions: Health departments
Health departments requested JYNNEOS and organized va ccination
campaigns
https://aspr.hhs.gov/SNS/Pages/JYNNEOS-Distribution .aspx
Stakeholder perceptions: Sermo survey of clinicians
Sermo*: Online community of >1.3 million clinicians
July 31 - August 1, 2022 survey results of U.S. clinicians (n=415): 69% felt U.S. without enough mpox vaccine to handle outbreak
September 12, 2022 survey of U.S. clinicians (n=62)
•66% had treated at least one mpox patient
•76% knew where a patient could get JYNNEOS vaccination
•86% wanted to be able to provide vaccination in their office
*https://app.sermo.com/barometer/unitedstates
Porter-Novelli Survey of Pediatricians (n=102) and Family Practice (FP) Practitioners (n=104)
Added 3 mpox vaccine questions to survey on pediatri c COVID-19 vaccine
attitudes and behaviors
Description of respondents' clinical practices:
–85% of FP and 88% of Pediatricians cared for children 12-17 years
–70% of FP and 60% of Pediatricians cared for patien ts 18+ years
–Majority (75%) in private practice; 14% practiced i n FQHC
–54% had >1500 patients in their practice
Porter Novelli Survey: Preference to provide JYNNEOS within medical practice,
PN survey of Pediatricians (N=102) and Family Practitioners (n=104), August
2023
Shift in vaccine administration sites from public h ealth
clinics to medical centers
•Public health providers administered 40% of all vaccines through Mar 2023
•Medical care providers administered an increasing proportion of vaccines since the start of the outbreak
•Pharmacies consistently provided 3-4% of all vaccines
Public Health
Provider or
Clinic Medical
Center
Provider Commercial
Vaccination
Service
Provider Pharmacy Other Percentage of Doses Administered
Categories of medical providers administering vacci nes
From 2022 to 2023, there were statistically significant increases in vaccines provided by •Primary care offices
•Federally qualifying health centers (FQHCs)
•Other health centers
Primary
Care Hospital FQHC Health
Center -
Other Health
Center -
STD/HIV Percentage of Doses Administered
FQHC: Federally qualifying health center
Online focus group by CDC: Healthcare provider perceptions of sexual health and mpox
Conducted to explore provider knowledge, attitudes, and practices related to
service delivery, including those specific to mpox
Recruitment targeting 50 providers via external rec ruiting firm
41 total participants – diverse by gender, race/ethn icity, practice setting, payment
methods for patients (e.g., private insurance plans , Medicaid, Medicare,
government programs), and clinical profession
61% reported spending ≥60% of their time providing sexual health services
59% private healthcare setting, 29% private and pub licly funded, 10% publicly
funded
54% in private practice, 20% STD/HIV/family plannin g clinic, 10% FQHC, 25% in ED
or urgent care
Responses from healthcare provider participants (N= 41)
68% had never managed an mpox case
34% believe mpox is a threat to public health
32% reported mpox is important to their patient popu lations
51% believe that mpox services (e.g., counseling) sh ould be integrated into
standard care for the following reasons
–Increase access to vaccine
–Improve education and awareness for patients
–Ensure STI screening is comprehensive
Is the intervention acceptable to key stakeholders
Is the intervention acceptable to key stakeholders
No Probably no Uncertain Probably yes Yes Varies
Health departments and clinicians are supportive of mpox v accines even if
pediatricians would prefer to refer patients to other clin ics to receive
JYNNEOS
Family practitioners would like to be able to provide JYNNEO S in their own
clinics
There has been a shift from JYNNEOS provided by public health providers to
JYNNEOS provided by medical center providers, including ST I and HIV clinics
EtR Domain: Resource Use
Is the intervention a reasonable and efficient allocation of resources
Current resources
–Vaccine only available via national government stoc kpiles
–JYNNEOS stockpiled for smallpox preparedness
–Doses used need to be replenished
–Significant use of resources (e.g., shipments, tran sportation, personnel) during
the outbreak and routine recommendation could be fu rther drain
Potential resources in the future: Uncertain wheth er it will be
commercialized but if so, unknown costs associated with commercialization
EtR Domain: Equity
Mpox and health equity
Disproportionate impact of mpox
–Gay, bisexual, and other MSM
–Black and Hispanic persons
–Persons experiencing homelessness
Any vaccine administered may decrease the disparity betw een the affected
population and others
Impact on health equity
Will facilitate 1:1 counseling and information shar ing in the privacy of a
clinic; vaccine recommendation from a clinician is associated with
increased vaccine uptake
$5,000,000 allocated to community-based organizations (C BOs) in
September 2023 to advance mpox prevention and vaccinat ion efforts*
–CBOS essential to increasing vaccination coverage a mong those at highest risk
and provided pivotal role during 2022
–42 CBOs funded so far
If commercialized, there may be an impact on primar y sites of vaccination
and on health departments
Recommendation might facilitate broad acceptance of vaccination (e.g., by
insurance companies, patients) because endorsed by ACIP after rigorous review
*https://www.cdcfoundation.org/pr/2023/mpox-vaccina tion-CBO-outreach
What would be the impact on health equity
What would be the impact on health equity?
Reduced Probably Reduced Probably no impact Probably increa sed
Increased Varies Don’t know
Access to vaccine (vs. no vaccine) may improve the health of persons who
are at risk for mpox
Routine recommendation may facilitate vaccinations
EtR Domain: Feasibility
Access to JYNNEOS vaccination if ACIP recommends it
Continue via national stockpiles free of cost to patients and providers
Mpox provider agreements* do not have a termination da te; they will
continue as long as vaccine is acquired via the US govern ment program and
can include new providers
Funding † provided to CBOs may improve feasibility
If commercialized §
–Via Medicare, Medicaid, commercial plans without copay
–Uninsured children via Vaccines for Children Program
–Some uninsured and underinsured adults might have difficu lty
*https://www.cdc.gov/poxvirus/mpox/clinicians/provi der-agreement.html
† https://www.cdcfoundation.org/pr/2023/mpox-vaccinat ion-CBO-outreach
§Uncertain whether it will be commercialized
Is the intervention feasible to implement?
Is the intervention feasible to implement
No Probably no Uncertain Probably yes Yes Varies
Subcutaneous vaccine; easy to administer
Standing orders available; JYNNEOS can be stored ref rigerated for 8 weeks
Recent analysis of shift in vaccine providers demon strates the continued
successful integration of JYNNEOS into providers’ pra ctices (e.g., STI and HIV care
settings, HIV care pharmacies, LGBTQ+ affirming pri mary care practices)
STI, HIV, and most family medicine/internal medicin e providers comfortable
providing vaccines but some pediatricians may prefe r referring patient to other
clinics
If commercialized, similar to other vaccines, cost of vaccine might impact access to
some populations
Summary of EtR
Domains Domains Domains
Benefits: How substantial are the desired anticipated effects Large Values: Does the target population feel desirable effects are large Probably Yes Impact on health equity Probably increased
Harms: How substantial are undesirable anticipated effects? Small Is there important uncertainty about or variability in values? Possibly important uncertainty or variability Feasible to implement ? Probably Yes
Benefit / Harm: Favors intervention Acceptable to stakeholders? Yes Balance of consequences:
Reasonable and efficient allocation of resources? Uncertain
Balance of Consequences
Undesirable Undesirable Balan ce between
consequences clearly conseque nces probably desirable and undesirab le
outweigh desirable outwei gh desirable consequences is closely
consequences in most consequen ces in most balanced or uncertain
settings settings Desirable consequences Desirable consequences There is insufficient evid ence
probably outweigh clear ly outweigh to determine the balance of
undesirable consequences undesirable consequences consequences
in most settings i n most settings X
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 that ACIP will revisit in 2 -3 years
† 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
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?