Estimated Effectiveness of JYNNEOS Vaccine in Preventing Mpox: A Multijurisdictional Case-Control Study - United States, August 19, 2022-March 31, 2023.
| Autor: | Dalton AF, Diallo AO, Chard AN, Moulia DL, Deputy NP, Fothergill A, Kracalik I, Wegner CW, Markus TM, Pathela P, Still WL, Hawkins S, Mangla AT, Ravi N, Licherdell E, Britton A, Lynfield R, Sutton M, Hansen AP, Betancourt GS, Rowlands JV, Chai SJ, Fisher R, Danza P, Farley M, Zipprich J, Prahl G, Wendel KA, Niccolai L, Castilho JL, Payne DC, Cohn AC, Feldstein LR |
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| Jazyk: | angličtina |
| Zdroj: | MMWR. Morbidity and mortality weekly report [MMWR Morb Mortal Wkly Rep] 2023 May 19; Vol. 72 (20), pp. 553-558. Date of Electronic Publication: 2023 May 19. |
| DOI: | 10.15585/mmwr.mm7220a3 |
| Abstrakt: | As of March 31, 2023, more than 30,000 monkeypox (mpox) cases had been reported in the United States in an outbreak that has disproportionately affected gay, bisexual, and other men who have sex with men (MSM) and transgender persons (1). JYNNEOS vaccine (Modified Vaccinia Ankara vaccine, Bavarian Nordic) was approved by the Food and Drug Administration (FDA) in 2019 for the prevention of smallpox and mpox via subcutaneous injection as a 2-dose series (0.5 mL per dose, administered 4 weeks apart) (2). To expand vaccine access, an Emergency Use Authorization was issued by FDA on August 9, 2022, for dose-sparing intradermal injection of JYNNEOS as a 2-dose series (0.1 mL per dose, administered 4 weeks apart) (3). Vaccination was available to persons with known or presumed exposure to a person with mpox (postexposure prophylaxis [PEP]), as well as persons at increased risk for mpox or who might benefit from vaccination (preexposure mpox prophylaxis [PrEP]) (4). Because information on JYNNEOS vaccine effectiveness (VE) is limited, a matched case-control study was conducted in 12 U.S. jurisdictions, † including nine Emerging Infections Program sites and three Epidemiology and Laboratory Capacity sites, § to evaluate VE against mpox among MSM and transgender adults aged 18-49 years. During August 19, 2022-March 31, 2023, a total of 309 case-patients were matched to 608 control patients. Adjusted VE was 75.2% (95% CI = 61.2% to 84.2%) for partial vaccination (1 dose) and 85.9% (95% CI = 73.8% to 92.4%) for full vaccination (2 doses). Adjusted VE for full vaccination by subcutaneous, intradermal, and heterologous routes of administration was 88.9% (95% CI = 56.0% to 97.2%), 80.3% (95% CI = 22.9% to 95.0%), and 86.9% (95% CI = 69.1% to 94.5%), respectively. Adjusted VE for full vaccination among immunocompromised participants was 70.2% (95% CI = -37.9% to 93.6%) and among immunocompetent participants was 87.8% (95% CI = 57.5% to 96.5%). JYNNEOS is effective at reducing the risk for mpox. Because duration of protection of 1 versus 2 doses remains unknown, persons at increased risk for mpox exposure should receive the 2-dose series as recommended by the Advisory Committee on Immunization Practices (ACIP), ¶ regardless of administration route or immunocompromise status. Competing Interests: All authors have completed and submitted the International Committee of Medical Journal Editors form for disclosure of potential conflicts of interest. Monica Farley reports institutional support from the National Institutes of Health (NIH), Infectious Diseases Clinical Research Consortium, and serving as the chair of the finance committee for the Southern Society for Clinical Investigation and on the finance committee for the National Foundation for Infectious Diseases. Sam Hawkins reports support from the Oregon Health Authority. Erin Licherdell reports contract support from Health Research, Inc. Ruth Lynfield reports travel support for meeting attendance from the Council of State and Territorial Epidemiologists, the Infectious Diseases Society of America, the American Academy of Pediatrics, and the National Foundation for Infectious Diseases. Linda Niccolai reports consulting fees from Merck and participation on data safety monitoring boards for Moderna and GSK. Karen A. Wendel reports institutional support from Hologic Inc., NIH, National Institute of Allergy and Infectious Diseases AIDS Clinical Trials Group for Study of Tecovirimat for Human Monkeypox Virus, honorarium for a lecture at the Bugs and Drugs Conference, University of Colorado, and co-chair of the Denver Metro Sexually Transmitted Infectious Coalition. No other potential conflicts of interest were disclosed. |
| Databáze: | MEDLINE |
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