Real-world data demonstrating vaccine effectiveness against mpox of up to 90% after two MVA-BN doses and a significant reduction of the risk of mpox-related hospitalizations
COPENHAGEN, Denmark, July 26, 2024 – Bavarian Nordic A/S (OMX: BAVA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of a type II variation for IMVANEX® (MVA-BN) smallpox and mpox vaccine, including real-world effectiveness data from the use of the vaccine during the global 2022 mpox outbreak in the marketing authorization.
In the absence of real-world data before the 2022 outbreak, the European marketing authorization of MVA-BN, granted in 2013 for smallpox prevention and extended in 2022 to include mpox, was based on efficacy data in non-human primates and immunogenicity data from numerous studies involving more than 4,000 healthy and immune-compromised individuals. These data demonstrated that MVA-BN had a favorable safety profile and induced immune responses that were non-inferior when compared to traditional smallpox vaccines, which are known to confer cross-protection against mpox and other orthopoxviruses.
After a systematic review and analysis of data from real-world observational studies conducted in vaccine-eligible individuals and published after the onset of the global mpox outbreak in 2022, Bavarian Nordic submitted an application to EMA in late 2023 for a type II variation, representing a major change to the marketing authorization for MVA-BN.
In the real-world studies, vaccine effectiveness against mpox disease was demonstrated at least 14 days after vaccination, with adjusted vaccine effectiveness estimates ranging from 35% (95% CI, -2-59) to 89% (95% CI, 76-95) after one MVA-BN dose and from 66% (95% CI, 47-78) to 90% (95% CI, 86-92) after two MVA-BN doses.
Furthermore, in a surveillance study, MVA-BN was shown to reduce the risks of mpox-related hospitalization. Compared with unvaccinated mpox patients,
