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National Center for Emerging and Zoonotic Infectious Diseases
JYNNEOS Vaccine Effectiveness
Anna Chard, PhD, MPH
LT, US Public Health Service
Vaccine Effectiveness Team
Vaccine Task Force
2022 Multinational Mpox Outbreak Response
Centers for Disease Control and Prevention
Advisory Committee on Immunization Practices
February 22, 2023
Background
Efficacy of JYNNEOS against mpox has been inferred from animal and
immunogenicity studies, but has never been demonstrated in clinical trials
Noreal-world vaccine effectiveness (VE) estimates for JYNNEOS against
mpox disease prior to current multinational outbreak
Key questions:
1. What is the effectiveness of JYNNEOS vaccine against mpox disease?
a) What is VE of partial (1 dose) versus full (2 doses) vaccination?
2. Are there differences in VE by route of vaccine administration?
3. Are there differences in VE among persons with immunocompromising conditions?
4. What is the duration of protection conferred from JYNNEOS vaccine?
Organization of presentation
Vaccine performance
Incidence of mpox among unvaccinated persons versus persons receiving ≥1 JYNNEOS
dose in the United States (U.S)
Vaccine effectiveness (VE) of JYNNEOS given as post-exposure prophylaxis
(PEP) against mpox disease, New York City
VE of JYNNEOS given as pre-exposure prophylaxis (PrEP) against mpox
disease
1. Israel single dose VE Study : Real-world effectiveness of a single dose of mpox vaccine
in males
2. EPIC Cosmos Case-Control Study: VE of 1 and 2 doses against mpox disease in the U.S
3. Multi-jurisdictional Case-Control Study : Interim estimate of VE of 2 doses against
mpox disease in 12 U.S. jurisdictions
4. New York State Case-Control Study : Preliminary estimates of VE of 1 and 2 doses
against mpox disease
Vaccine performance
Weekly mpox incidence by vaccination status: Methods
Data sources: Mpox case data, vaccine administration data, estimates of the
vaccine eligible population*
Design: Comparison of mpox incidence among persons who were
unvaccinated and those who had received either 1 or 2 JYNNEOS doses
Population: 9,544 reported mpox cases among men aged 18–49 years from
43 U.S. jurisdictions
Time period: July 31–October 1, 2022
Analysis:
Estimated weekly mpox incidence for persons with partial (1 dose) and full (2 doses)
vaccination and persons eligible but unvaccinated
Calculated incidence rate ratio using negative binomial regression
*Estimated population per jurisdiction of men who have sex with men (MSM) who are living with HIV or MSM who are eligible for HIV pre -
exposure prophylaxis.
Source: Payne AB, et al. Reduced Risk for Mpox After Receipt of 1 or 2 Doses of JYNNEOS Vaccine Compared with Risk Among Unvaccinated
Persons — 43 U.S. Jurisdictions, July 31–October 1, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1560–1564.
July 31, 2022 – October 1, 2022 (43 U.S. jurisdictions**)
Unvaccinated
350
300
250
200 150
100
50
0 Vaccine dose 1 received ≥ 14 days earlier
Vaccine dose 2 received ≥ 14 days earlier Monkeypox Incidence
31-Jul-22
2-Aug-22 4-Aug-22 6-Aug-22 8-Aug-22
10-Aug-22 12-Aug-22 14-Aug-22 16-Aug-22 18-Aug-22 20-Aug-22 22-Aug-22 24-Aug-22
26-Aug-22
28-Aug-22 30-Aug-22
1-Sep-22 3-Sep-22 5-Sep-22 7-Sep-22 9-Sep-22
11-Sep-22 13-Sep-22
15-Sep-22
17-Sep-22 19-Sep-22 21-Sep-22 23-Sep-22 25-Sep-22
Week
Weekly mpox incidence,*by vaccination status
eligible for vaccination§among males aged 18–49 years
Mpox incidence among unvaccinated
individuals was 7.4 (95% CI = 6.0–9.1) times
as high as persons receiving 1 dose of
JYNNEOS vaccine .
Mpox incidence among unvaccinated
individuals was 9.6 (95% CI = 6.9–13.2)
times as high as persons receiving 2 doses
of JYNNEOS vaccine .
No difference observed in vaccine
performance be tween subcutaneous and
intradermal administration .
* Cases per 100,000 population. Rate in vaccinated persons = number of probable or confirmed cases reported to CDC with date of illness onset, specimen collection, lab test completion, admission, diagnosis, discharge, case investigation start date, or date first electronically submitted or
reported to the county, state, or public health department (earliest available date) ≥14 days after receiving the first dose or second dose of JYNNEOS vaccine among total vaccinated population as of 2 weeks previously. Rate in unvaccinated persons = number of probable or confirmed cases
reported to CDC without evidence of vaccination among total unvaccinated population. § Gay, bisexual, and other men who have sex with men who have HIV infection or who are eligible to receive HIV preexposure prophylaxis were considered eligible for vaccination. ¶ Alabama, Alaska, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nevada, New Hampshire, New Mexico, New York (excluding New York City), North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Utah, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming. ** Jurisdictions were included if age and sex assigned at birth or gender identity was available for ≥70% of cases reported, vaccination status was available for ≥50% of cases in males (defined by either sex assigned at birth or gender identity) aged 18–49 years or the jurisdiction confirmed cases were linked to immunization registry entries, and de-identified vaccination administration data were submitted to CDC.
Source : Payne AB, et al. Reduced Risk for Mpox After Receipt of 1 or 2 Doses of JYNNEOS Vaccine Compared with Risk Among Unvaccinated Persons — 43 U.S. Jurisdictions, July 31–October 1, 2022. MMWR Morb Mortal Wkly Rep 2022;71:1560–1564.
Vaccine effectiveness of JYNNEOS
administered as PEP against mpox
JYNNEOS effectiveness as PEP against mpox, New York City
(unpublished data)
Design: Cohort evaluation of individuals ages >18 years residing in NYC identified through
routine Department of Health contact investigations to a case-patient with mpox between May
22—August 24, 2022 and no vaccination or disease history prior to exposure
PEP: Receipt of 1st dose of JYNNEOS <14 days of exposure and prior to date of symptom onset,
if applicable
Case-patient : Exposed individuals who developed symptom onset <21 days after exposure
(incubation period) with laboratory confirmation
Analysis : VE of a single dose of JYNNEOS administered subcutaneously <14 days after exposure
as PEP for preventing laboratory-confirmed mpox disease as [(1 – Relative Risk) × 100%]
Results: Among individuals with high-risk* exposure, vaccine effectiveness was 77% (95% CI:
51%-92%) with PEP <14 days after last exposure (n=273) and 79% (46%-94%) with PEP <14
days after first exposure (n=208)**
*Defined according to the CDC Interim Community Exposure Risk Assessment and Recommendations
***Unadjusted; in univariate analyses, race/ethnicity and age-group were not significantly associated with mpox disease
Vaccine effectiveness of JYNNEOS
administered as PrEP against mpox
Israel single-dose VE study: Methods
V accination: Single, subcutaneous dose of Modified Vaccinia Ankara-Bavarian
Nordic (MVA-BN)
Design: Retrospective, observational cohort using electronic health record s
from a singl e integrated health center in Israel
Population: 2,054 men eligible* for vaccinati on
Time period: July 31 , 2022 – December 25 , 2022
Analysis :
VE estimated using Co x proportional hazards regressio n with vaccination status as a
time-varyi ng covariate
M
odel adjusted for sociodemographic and clinical risk factors
*Males aged 18 – 42 years who were dispensed HIV-PrEP at least for one month since January 1, 2022, or (b) males aged 18 – 42 years who were diagnosed with HIV
and also were diagnosed with one or more sexually transmitted infections (STIs) since January 1, 2022.
Source : Sagy, Y. W. et al. Real-world effectiveness of a single dose of mpox vaccine in males. Nature Medicine https://doi.org/10.1038/s41591-023-02229-3 (2023).
Israel single-dose VE study: Results
• 5 mpox cases among vaccinated
individuals
• 16 mpox cases among
unvaccinated individuals
• Adjusted single-dose vaccine
effectiveness was 86% (95% CI: 59%-95%)
Source : Sagy, Y . W. et al. Real-world effectiveness of a single dose of mpox vaccine in males. Nature Medicine https://doi.org/10.1038/s41591 -
023-02229-3 (2023).
Epic Cosmos Case-Control Study: Methods
Data Source: Epic’s electronic health record (EHR) platform, Cosmos, which
includes records from >169 million patients across the U.S.
Analysis:
Design: Case-control analysis, matched 1:4 based on week of index event,
HHS region, and gender identity
Case patients: Patients wit h an mpox diagnosis or positive orthopoxvirus or mpox
virus laboratory result from 8/15 - 11/19/2022
Control patients : Patients wit h an incident HIV diagnosis or HIV pre-exposur e
prophylaxis (PrEP) prescription from 8/15 - 11/19/2022
VE estimated using conditional logistic regression
Adjusted for age , race/ethnicity, social vulnerability index , immunocompromisin g
conditions
Stratified by route of administration and immunocompromised status
Cases Controls Adjusted* VE (95% CI) (n=2,913) (n=8,319)
Overall VE, full vaccination (2 doses) 25 335 66 (47, 78)
No immunocompromising conditions 14 312 76 (58, 87)
2 doses administered subcutaneously 6 63 54 (-9, 81) 2 doses administered intradermally 5 42 46 (-45, 80) 2 doses administered heterologously 8 150 75 (48, 88)
Overall VE, partial vaccination (1 dose) 146 1000 36 (22, 47)
No immunocompromising conditions 102 932 41 (25, 53) 1 dose administered subcutaneously 106 704 32 (15, 45) 1 dose administered intradermally 27 186 41 (7, 62)
-60 - 40 - 20 0 20 40 60 Vaccine Effectiveness (% )80 100
Epic Cosmos Case-Control Study: JYNNEOS VE for fulland partial
vaccination, August 15-November 19, 2022, United States
(unpublished data)
*Adjusted for age, race/ethnicity, social vulnerability index, and immunocompromising conditions .
C
ases/controls matched on week of index event, HHS region, gender identity .
Multi-jurisdictional Case-Control Study: Methods
Design: Case-control study
Population: Men who have sex with men; ages 18-49; 12 U.S. jurisdictions
Methods:
Cases identified from jurisdictions’ probable and confirmed mpox case
lists
Controls identified from healthcare settings providing HIV PrEP or
sexually transmitted infection (STI) clinics
Demographics, exposure history, and vaccination history collected using
electronic surveys
Vaccination status confirmed by state immunization registries
Analysis: Logistic regression with random intercept for jurisdiction and
adjusted for age, race/ethnicity, number of sexual partners, close contact with a confirmed/probable case, and month of index event
Multi-jurisdictional Case-Control Study Interim Results: VE for full
vaccination (unpublished data)
Cases Controls Adjusted* VE (95% CI) (n=167) (n=256)
Overall VE, full vaccination (2 doses) 14 122 76% (48%-89%)
No immunocompromising conditions 8 61 90% (66%-97%)
Immunocompromising conditions
Overall VE, partial vaccination (1 dose) Not sufficiently powered for interim analysis
No immunocompromising conditions
Immunocompromising conditions
0 20 40 60 80 100
Vaccine Effectiveness (%)
*Adjusted for age, race/ethnicity, immunocompromised status, reported clos e contact with a
confirmed/suspected mpox cas e in 3 week s prior to index event, and month o f index event
New York State Case-Control Study: Preliminary Estimates
(unpublished data)
Data source: Linkage of case surveillance to immunization registry in New York
State, excluding New York City
Cases : Adult male mpox cases during July 24 – October 31, 2022
Controls : Adult male STI cases (rectal gonorrhea or primary syphilis) during July
24 – October 31, 2022
Analysis: Conditional logistic regression model adjusted for diagnosis week, race,
age, region within state
mpox cases
(n=252) STI controls
(n=255) VE (95% CI)
Partial vaccination 10 (4%) 23 (9%) 68% (25%, 86%) Unvaccinated 230 (91%) 204 (80%) ref.
Full vaccination 2 (1%) 19 (7%) 89% (44%, 98%)
Summary
Cases Controls Adjusted* VE (95%
Epic Cosmos case-control study 25 335 66% (47%- 78%)
New York State case-control study 2 19 89% (44%-98%)
Partial vaccination (1 dose)
5 16 86% (59%-95%)
Epic Cosmos case-control study 146 1000 36% (22%-47%)
Vaccine effectiveness of JYNNEOS against mpox ranges from 66% -
89% for full vaccination and 36%-86% for partial vaccination
CI)
0 20 40 60 80 100
Vaccine Effectiveness (%) Full v accination (2 doses)
Mul
ti-jurisdictional case-control study 14 122 76% (48%-89%)
Israel single-dose study
New York State case-control study 10 23 68% (25%-86%)
Vaccine effectiveness of JYNNEOS against mpox
JYNNEOS vaccine i s effective at reducing risk of mpox disease
Protection provided by both 1 and 2 doses of JYNNEOS vaccine
Highest protection provided by 2 doses , regardles s of route of
administration
Further research needed to evaluate whether immunocompromised statu s
modulates V E
Further research needed to assess duration of protection
Acknowledgements
• Alpha Oumar Diallo • Jennifer B. Rosen • Jemma Rowlands • Gennesis Quinonez
• Robert J. Arciuolo • Ghinwa Dumyati • Paola Santos • Alexandra Dalton
• Preeti Pathela • Christina Felsen • AmberJean Hansen
• Amy Fothergill • Jennifer Baumgartner • Erin Licherdell • James Meek
• Julia Latash • Kristin Smith • Linda Niccolai • Leora Feldstein
• Lenka Malec • Shealynn Hilliard • Quyen PhanLynn Sosa • Nicholas Deputy • Ellen H. Lee • Will Still • Sydney Jones
• Danielle Moulia • Vasudha Reddy • Allison Morrow • Gabriela Betancourt
• Renee King • Sarah Gillani • Ciarra Leocadio • Amanda Payne • Joseph Edward Real • Eric Anthony • Preeti Pathela
• Tom Shimabukuro • Jane R. Zucker • Mary Fran DeRose • Robyn Weber
• Jessica Castilho • Gregory Prahl • Mo Patel • Investigators from New York State Health • Mary Margaret Fill • Masayo Nishiyama
• Adam Cohen Dept • Keipp Talbot • Jesse J. Carlson
• Eli Rosenberg • Tiffanie Markus • Kevin Kamis • Rosalind Carter
• Vajeera Dorabawila • Danielle Ndi • Gena Simien • Amanda Cohn • Rachel Hart-Malloy • Kristine Mansilla-Dubon • Karen A. Wendel
• Daniel Payne • Wilson Miranda • Bentley Akok • Ginger Stringer
• Bridget Anderson • Sweta Tiwari • Rachel Herlihy • Logan Ray • Bryon Backenson • Caleb Wiedeman • Jennifer House
• Kristen Kugeler • Charlotte DelBarba • Jacqueline Logan • California Department of Public Health
• Meaghan Abrego • Greg Chambers • Alameda County Public Health • Michelle Canning Department (CA) • Yelena Tourkina • Cori Tice • Robbie Snyder • Matthew Cole • Kim Toevs • Claire McGarry • Shua Chai • Kennedy Houck • Emily Lutterloh • Lynn Rampe • Arthur L. Reingold • Eric Richardson • Michele Boulais • Steven Gibson • Nathaniel Lewis • Jaxon Mitchell • Ethan Mitchell • Eileen Dunne • Josh Arevalo • Jennifer Farrar • Charles Gonzalez • Rebecca Fisher • Melissa Sutton • Travis O’Donnell • Lizzie White • Phoebe Danza • Paul Cieslak • Michael Kharfen • Erin Peterson • Epic COSMOS Investigators • James McDonald • Sam Hawkins • Jane Lam • Jackie Gerhart • Ursula Bauer • Amber Britton
• Gabriel Garcia-Lopez • Danessa Sandman • Bianca Perez • Robert Bolan • Dave Little • Multi-jurisdictional case-control study • Erica Hazra • Sharon Balter • Cory Sweet investigators: • Molly McAlvany • Sonali Kulkarni • Joe Deckert • Taelor Moran • Bridget Anderson • Nava Yeganeh • Eric Barkley • Tamsin van der Woude • Suzanne McGuire • Andrea Kim • Neil Sandburg • Katherine Lee • Adam Rowe
• Rachael Gill • Kerianne Engesser • Investigators from NYC Health
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