Bavarian Nordic Gets Positive CHMP Opinion to Add Mpox Effectiveness Data to EU Vaccine Authorization

Bavarian Nordic A/S has 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 the MVA-BN vaccine, marketed under the name IMVANEX®, aimed at preventing smallpox and mpox. This recommendation comes after the inclusion of real-world effectiveness data from the 2022 global mpox outbreak. 

Before the widespread outbreak in 2022, the European marketing authorization for MVA-BN was based on data from non-human primate studies and immunogenicity data from over 4,000 healthy and immune-compromised individuals. These studies demonstrated that MVA-BN had a favorable safety profile and induced immune responses comparable to traditional smallpox vaccines, which are known to provide cross-protection against mpox and other orthopoxviruses.

Following a systematic review and analysis of observational studies conducted during the 2022 mpox outbreak, Bavarian Nordic applied for a type II variation to the marketing authorization of MVA-BN. These real-world studies demonstrated that vaccine effectiveness against mpox was observed at least 14 days after vaccination. The adjusted vaccine effectiveness ranged from 35% to 89% after one dose and from 66% to 90% after two doses.

Moreover, surveillance studies indicated that MVA-BN significantly reduced the risk of mpox-related hospitalizations. The odds of hospitalization were significantly lower for vaccinated individuals compared to those unvaccinated. Specifically, the risk reduction was 73% after one dose and 80% after two doses.

The CEO of Bavarian Nordic, Paul Chaplin, commented that the 2022 global mpox outbreak provided an opportunity to assess the vaccine's effectiveness in at-risk populations across different regions. The recommendation to include real-life data in the European marketing authorization confirms the vaccine's high effectiveness of up to 90% after two doses and its substantial role in reducing hospitalizations.

The MVA-BN vaccine, also known as Modified Vaccinia Ankara-Bavarian Nordic, is marketed under various names such as JYNNEOS®, IMVANEX®, and IMVAMUNE®. It is a non-replicating vaccine approved by several regulatory agencies, including the FDA, EC, Health Canada, MHRA, and Swissmedic. It has also received emergency use authorization in other territories to combat the mpox outbreak. Initially developed in collaboration with the U.S. government, the vaccine aimed to ensure the availability of a smallpox vaccine for the entire population, including those who are immunocompromised.

Bavarian Nordic has long been a supplier of this vaccine to the U.S., Canada, and several other nations as part of their national biological preparedness efforts. During the 2022-2023 mpox outbreak, Bavarian Nordic expanded vaccine access to over 70 countries worldwide to support governments and international organizations.

Bavarian Nordic is a fully integrated vaccine company dedicated to protecting and saving lives through innovative vaccines. The company is a global leader in smallpox and mpox vaccines, supplied to governments to enhance public health preparedness and maintain a robust portfolio of vaccines for travelers and endemic diseases.

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