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.

Fig. 1. Cumulative hazard for mpox infection (95% CIs).

For unvaccinated participants, time zero corresponds to 31 July 2022, when the vaccination campaign was initiated. For vaccinated participants, time zero corresponds to the date of vaccine uptake. The shaded areas indicate the 95% CIs.

Extended Data Fig. 1

Study timeline.For unvaccinated participants, time zero corresponds to 31 July 2022, when the vaccination campaign was initiated. For vaccinated participants, time zero corresponds to the date of vaccine uptake. The figure depicts the transition from unvaccinated to vaccinated status, as applied in the time-dependent Cox model.