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Real-world effectiveness of a single dose of mpox vaccine in males.

ABSTRACT: 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.

SUBMITTER: Wolff Sagy Y

PROVIDER: S-EPMC9930701 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature

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Real-world effectiveness of a single dose of mpox vaccine in males.

Wolff Sagy Yael Y Zucker Roy R Hammerman Ariel A Markovits Hila H Arieh Noa Gur NG Abu Ahmad Wiessam W Battat Erez E Ramot Noga N Carmeli Guy G Mark-Amir Avner A Wagner-Kolasko Gal G Duskin-Bitan Hadar H Yaron Shlomit S Peretz Alon A Arbel Ronen R Lavie Gil G Netzer Doron D

Nature medicine 20230131 3

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 Organizatio ...[more]

PMID: 36720271

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Project description:BackgroundMpox infection is a zoonotic illness that resembles smallpox. Vaccination is widely regarded as a vital effective method of preventing mpox, however, there is lack of consensus of effectiveness of a single dose of mpox vaccine in the current 2022-2023 outbreak. We pooled data from real-world studies to evaluate the efficacy of the JYNNEOS vaccination given as a single dosage.MethodWe carried out a thorough literature search in PubMed, Web of Science, and Scopus up until August 2023. We estimated the pooled vaccine effectiveness (VE) for mpox using inverse variance method in a random-effects meta-analysis. We expressed the results as VE, 95% confidence interval (95% CI), and 95% prediction interval (95% PI) using R v4.3.0. We assessed influence, heterogeneity contribution, and influence of studies using several tests and conducted sensitivity analysis accordingly. We used Doi plot and Luis Furuya-Kanamori (LFK) index to evaluate publication bias.ResultsWith a total sample size of 35,326 individuals, we involved 11 studies in the meta-analysis. The VE of a single dose of JYNNEOS vaccine was 78.23% (95% CI: 62.79%-87.27%) by pooling data of 24,784 individuals over seven studies. The findings were heterogenous with a 95% PI of -32.14% to 96.41% depicting the expected range of VE in similar settings. Notably, VE increased to 83.02% (74.62%-88.64%) with a prediction interval of (44.67%-94.79) after sensitivity analysis by leaving out outliers. The results were robust in light of several sensitivity analyses. An asymmetric Doi plot with LFK index of -2.25 showed potential publication bias. Pooled prevalence of mpox infection among vaccinated individuals (breakthrough infection) in six studies was 2.19% (0.37%-5.32%).ConclusionThe present findings provide compelling evidence that a single dose of JUNNEOS vaccine can protect recipients from mpox infection. With a 78.23% estimated efficacy rate, the vaccine is thought to be a useful tool in preventing further spread of mpox. However, more research and ongoing surveillance are required to fully understand the reasons behind breakthrough infections and to improve immunization strategies for better protection against mpox.

Dataset Information

Real-world effectiveness of a single dose of mpox vaccine in males.

Publications

Real-world effectiveness of a single dose of mpox vaccine in males.

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