Real-world effectiveness of a single dose of mpox vaccine in males.
Journal
Nature medicine
ISSN: 1546-170X
Titre abrégé: Nat Med
Pays: United States
ID NLM: 9502015
Informations de publication
Date de publication:
03 2023
03 2023
Historique:
received:
15
11
2022
accepted:
20
01
2023
pubmed:
1
2
2023
medline:
25
3
2023
entrez:
31
1
2023
Statut:
ppublish
Résumé
The recent global outbreak of the monkeypox (mpox) virus in humans was declared a public health emergency by the World Health Organization in July 2022. The smallpox and mpox vaccine (JYNNEOS; Modified Vaccinia Ankara-Bavarian Nordic; MVA-BN), provided as a two-dose regimen, is currently the primary vaccine utilized against mpox. However, the efficacy of MVA-BN against mpox has never been demonstrated in clinical trials to date. Due to the limited supply of vaccines, the World Health Organization has recommended prioritizing the vaccination of high-risk groups. We evaluated the real-world effectiveness of a single, subcutaneous dose of MVA-BN in this observational, retrospective cohort study, which included the analysis of electronic health records of all members of Clalit Health Services eligible for the vaccine on 31 July 2022. We used a Cox proportional hazards regression model with time-dependent covariates to estimate the association between vaccination and mpox while adjusting for sociodemographic and clinical risk factors. In an analysis of 2,054 male individuals who met vaccine eligibility criteria, 1,037 (50%) were vaccinated during the study recruitment period and completed at least 90 d of follow-up. During the study period, 5 and 16 infections were confirmed in vaccinated and unvaccinated individuals, respectively. The adjusted vaccine effectiveness was estimated at 86% (95% confidence interval, 59-95%). Our results suggest that a single dose of subcutaneous MVA-BN in this high-risk cohort is associated with a significantly lower risk of MPXV infection.
Identifiants
pubmed: 36720271
doi: 10.1038/s41591-023-02229-3
pii: 10.1038/s41591-023-02229-3
pmc: PMC9930701
doi:
Substances chimiques
Smallpox Vaccine
0
Types de publication
Observational Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
748-752Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Nature America, Inc.
Références
Thornhill, J. P. et al. SHARE-net clinical group. Monkeypox virus infection in humans across 16 countries—April–June 2022. N. Engl. J. Med. 387, 679–691 (2022).
doi: 10.1056/NEJMoa2207323
pubmed: 35866746
US Food & Drug Administration. Key facts about monkeypox vaccine. Available from: https://www.fda.gov/vaccines-blood-biologics/vaccines/key-facts-about-monkeypox-vaccine . Extracted on 1 October 2022.
World Health Organization. Vaccines and immunization for monkeypox. Interim guidance—14 June 2022. https://apps.who.int/iris/bitstream/handle/10665/356120/WHO-MPX-Immunization-2022.1-eng.pdf
Nuzzo, J. B., Borio, L. L. & Gostin, L. O. The WHO declaration of monkeypox as a global public health emergency. JAMA https://doi.org/10.1001/jama.2022.12513 (2022).
Mathieu, E., et al. Monkeypox. Our world in data 2022 https://ourworldindata.org/monkeypox . Extracted on 14 November 2022.
World Health Organization. 2022 monkeypox outbreak: global trends. https://worldhealthorg.shinyapps.io/mpx_global/ . Extracted on 12 November 2022.
US Food & Drug Administation. JYNEOS prescribing information. https://www.fda.gov/media/131078/download . Extracted on 1 October 2022.
Centers for Disease Control and Prevention. Rates of monkeypox cases by vaccination status. Updated 8 December 2022. https://www.cdc.gov/poxvirus/monkeypox/cases-data/mpx-vaccine-effectiveness.html . Extracted on 29 December 2022.
Del Rio, C. & Malani, P. N. Update on the monkeypox outbreak. JAMA 328, 921–922 (2022).
doi: 10.1001/jama.2022.14857
pubmed: 35951336
Hazra, A. et al. Human monkeypox virus infection in the immediate period after receiving modified Vaccinia Ankara vaccine. JAMA https://doi.org/10.1001/jama.2022.18320 (2022).
Pittman, P. R. et al. Phase 3 efficacy trial of modified Vaccinia Ankara as a vaccine against smallpox. N. Engl. J. Med. 381, 1897–1908 (2019).
doi: 10.1056/NEJMoa1817307
pubmed: 31722150
Kupferschmidt, K. Scientists scramble to set up monkeypox vaccine trials. Science 377, 696–697 (2022).
doi: 10.1126/science.ade3371
pubmed: 35951681
Reardon, S. What does the future look like for monkeypox? Nature 610, 250–252 (2022).
doi: 10.1038/d41586-022-03204-7
pubmed: 36224412
Earl, P. L. et al. Immunogenicity of a highly attenuated MVA-BN smallpox vaccine and protection against monkeypox. Nature 428, 182–185 (2004).
doi: 10.1038/nature02331
pubmed: 15014500
Thy, M. et al. Breakthrough infections after post-exposure vaccination against mpox. N. Engl. J. Med. 387, 2477–2479 (2022).
doi: 10.1056/NEJMc2211944
pubmed: 36477495
Rubin, E. J. et al. Audio interview: responding to monkeypox. N. Engl. J. Med. 387, e21 (2022).
doi: 10.1056/NEJMe2210967
pubmed: 36070718
Zucker, R. et al. Risk assessment of human monkeypox infections for vaccine prioritization. https://doi.org/10.21203/rs.3.rs-1904714/v2 (2022).
Baetselier, I. et al. Retrospective detection of asymptomatic monkeypox virus infections among male sexual health clinic attendees in Belgium. Nat. Med. https://doi.org/10.1038/s41591-022-02004-w (2022)..
US Food & Drug Administration. Fact sheet for healthcare providers administering vaccine: emergency use authorization of JYNNEOS. https://www.fda.gov/media/160774/download . Extracted on 1 October 2022.
Brooks, J. T., Marks, P., Goldstein, R. H. & Walensky, R. P. Intradermal vaccination for monkeypox—benefits for individual and public health. N. Engl. J. Med. 387, 1151–1153 (2022).
doi: 10.1056/NEJMp2211311
pubmed: 36044621
WHO. Monkeypox. Key facts. May 19 2022. https://www.who.int/news-room/fact-sheets/detail/monkeypox
Arbel, R. et al. Nirmatrelvir use and severe COVID-19 outcomes during the omicron surge. N. Engl. J. Med. 387, 790–798 (2022).
doi: 10.1056/NEJMoa2204919
pubmed: 36001529
Lévesque, L. E. et al. Problem of immortal time bias in cohort tudies: example using statins for preventing progression of diabetes. BMJ 340, b5087 (2010).
doi: 10.1136/bmj.b5087
pubmed: 20228141
Bursac, Z., Gauss, C. H., Williams, D. K. & Hosmer, D. W. Purposeful selection of variables in logistic regression. Source Code Biol. Med. 3, 17 (2008).
doi: 10.1186/1751-0473-3-17
pubmed: 19087314
pmcid: 2633005