2-Dose Mpox Vaccination Up to 90% Effective

Bavarian Nordic A/S today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended the approval of a type II variation for IMVANEX® (MVA-BN, JYNNEOS®) smallpox and mpox vaccine.

This EMA recommendation includes real-world effectiveness data from the use of the vaccine during the global 2022 mpox outbreak in the marketing authorization.

In 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 reduced the risks of mpox-related hospitalization.

Compared with unvaccinated mpox patients, the odds of hospitalization were 0.27 (95% CI, 0.08-0.65) after one MVA-BN dose and 0.20 (95% CI, 0.01-0.90) after two MVA-BN doses. The estimated relative risk reduction was 73% after one MVA-BN dose and 80% after two MVA-BN doses.

“The 2022 global mpox outbreak provided an opportunity to assess the effectiveness of our vaccine in at-risk populations across different geographies, both before and after exposure to the mpox virus, and we are pleased to receive the recommendation to include real-life data in our marketing authorization in Europe, which confirm a high effectiveness of up to 90% after two doses of the vaccine as recommended by the authorities. It is furthermore encouraging that data show the vaccine to reduce the risk of hospitalizations significantly, thus confirming our vaccine as an important and versatile tool in the fight against mpox globally,” said Paul Chaplin, President and Chief Executive Officer of Bavarian Nordic, in a press release on July 26, 2024.

As of July 2024, the JYNNEOS vaccine is commercially available in the United States.