Effectiveness of JYNNEOS Vaccine Against Diagnosed Mpox Infection - New York, 2022.
Study Design
- Studientyp
- Case-Control
- Stichprobengröße
- 507
- Intervention
- Effectiveness of JYNNEOS Vaccine Against Diagnosed Mpox Infection - New York, 2022. JYNNEOS vaccine (2-dose series, 4 weeks apart)
- Vergleichsgruppe
- Placebo
- Wirkungsrichtung
- Positive
- Verzerrungsrisiko
- Moderate
Abstract
In 2022, an international Monkeypox virus outbreak, characterized by transmission primarily through sexual contact among gay, bisexual, and other men who have sex with men (MSM), resulted in 375 monkeypox (mpox) cases in the state of New York outside of New York City (NYC).*,† The JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic), licensed by the U.S. Food and Drug Administration (FDA) against mpox as a 2-dose series, with doses administered 4 weeks apart,§ was deployed in a national vaccination campaign.¶ Before this outbreak, evidence to support vaccine effectiveness (VE) against mpox was based on human immunologic and animal challenge studies (1-3). New York State Department of Health (NYSDOH) conducted a case-control study to estimate JYNNEOS VE against diagnosed mpox in New York residents outside of NYC, using data from systematic surveillance reporting. A case-patient was defined as a man aged ≥18 years who received a diagnosis of mpox during July 24-October 31, 2022. Contemporaneous control patients were men aged ≥18 years with diagnosed rectal gonorrhea or primary syphilis and a history of male-to-male sexual contact, without mpox. Case-patients and control patients were matched to records in state immunization systems. JYNNEOS VE was estimated as 1 - odds ratio (OR) x 100, and JYNNEOS vaccination status (vaccinated versus unvaccinated) at the time of diagnosis was compared, using conditional logistic regression models that adjusted for week of diagnosis, region, patient age, and patient race and ethnicity. Among 252 eligible mpox case-patients and 255 control patients, the adjusted VE of 1 dose (received ≥14 days earlier) or 2 doses combined was 75.7% (95% CI = 48.5%-88.5%); the VE for 1 dose was 68.1% (95% CI = 24.9%-86.5%) and for 2 doses was 88.5% (95% CI = 44.1%-97.6%). These findings support recommended 2-dose JYNNEOS vaccination consistent with CDC and NYSDOH guidance.
Full Text
Figures
Tables
TABLE 1
| Characteristic | No. (%) | p-value | |
|---|---|---|---|
| Mpox case-patients (n = 252) | STI control patients* (n = 255) | ||
|
| |||
| 18–29 | 94 (37.3) | 111 (43.5) | 0.34 |
| 30–39 | 90 (35.7) | 75 (29.4) | |
| 40–49 | 37 (14.7) | 33 (12.9) | |
| ≥50 | 31 (12.3) | 36 (14.1) | |
|
| |||
| Black or African American, NH | 48 (19.8) | 68 (32.1) | <0.001 |
| White, NH | 69 (28.4) | 90 (42.5) | |
| Hispanic or Latino | 106 (43.6) | 40 (18.9) | |
| Other, NH | 20 (8.2) | 14 (6.6) | |
| Unknown | 9 (3.6) | 43 (16.7) | |
|
| |||
| Metropolitan region outside NYC¶ | 173 (68.7) | 91 (35.7) | <0.001 |
| Rest of New York outside NYC | 79 (31.3) | 164 (64.3) | |
TABLE 2
| Vaccination status | Mpox
case-patients
(n = 252) | All STI controls
(n = 255) | |
|---|---|---|---|
| No. (%) | No. (%) | VE (95% CI) | |
| Unvaccinated | 230 (91.3) | 204 (80.0) | Ref |
| 0–13 days after first dose | 10 (4.0) | 9 (3.5) | –36.2 (<–100 to 56.3) |
| ≥14 days after first dose | 10 (4.0) | 23 (9.0) | 68.1 (24.9 to 86.5) |
| ≥0 days after second dose | 2 (0.8) | 19 (7.5) | 88.5 (44.1 to 97.6) |
| ≥14 days after first dose or ≥0 days after second dose | 12 (4.8) | 42 (16.5) | 75.7 (48.5 to 88.5) |
References
- Phase 3 efficacy trial of Modified Vaccinia Ankara as a vaccine against smallpox. N Engl J Med, 2019
- Comparison of lyophilized versus liquid Modified Vaccinia Ankara (MVA) formulations and subcutaneous versus intradermal routes of administration in healthy vaccinia-naïve subjects. Vaccine, 2015
- Rapid protection in a monkeypox model by a single injection of a replication-deficient vaccinia virus. Proc Natl Acad Sci U S A, 2008
- COVID-19 vaccine effectiveness in New York state. N Engl J Med, 2022
- 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
- Incidence of monkeypox among unvaccinated persons compared with persons receiving ≥1 JYNNEOS vaccine dose—32 U.S. jurisdictions, July 31–September 3, 2022. MMWR Morb Mortal Wkly Rep, 2022
- Real-world effectiveness of a single dose of mpox vaccine in males. Nat Med, 2023
- Estimated effectiveness of JYNNEOS vaccine in preventing mpox: a multijurisdictional case-control study—United States, August 19, 2022–March 31, 2023. MMWR Morb Mortal Wkly Rep, 2022
- Strategies adopted by gay, bisexual, and other men who have sex with men to prevent monkeypox virus transmission—United States, August 2022. MMWR Morb Mortal Wkly Rep, 2022
- Modeling the impact of sexual networks in the transmission of Monkeypox virus among gay, bisexual, and other men who have sex with men—United States, 2022. MMWR Morb Mortal Wkly Rep, 2022
Used In Evidence Reviews
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