Bavarian Nordic Seeks EMA Approval to Extend Mpox/Smallpox Vaccine to Adolescents

Interim clinical study results have demonstrated the non-inferiority of immune responses from the mpox/smallpox vaccine in adolescents compared to adults, showcasing a similar safety profile. This finding supports the potential extension of the current approval in Europe by late 2024. Bavarian Nordic A/S has submitted clinical data to the European Medicines Agency (EMA) to expand the use of its IMVANEX® (MVA-BN®) smallpox and mpox vaccine to adolescents aged 12 to 17.

Currently, the vaccine is approved only for adults aged 18 and above, although it received an Emergency Use Authorization from the FDA for adolescents during the 2022 global mpox outbreak. IMVANEX remains the sole mpox vaccine approved by both the FDA and EMA. The submission is based on interim results from a clinical study involving 315 adolescents (aged 12-17) and 211 adults (aged 18 and older). Conducted by the U.S. National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID), the study revealed that the immune responses in adolescents were not inferior to those in adults, and the safety profile was comparable between the two groups after administering two standard doses of the MVA-BN vaccine.

Upon review by the EMA, the Marketing Authorization for IMVANEX could be extended to include adolescents by the fourth quarter of 2024. Additionally, Bavarian Nordic is planning a clinical trial to evaluate the immunogenicity and safety of MVA-BN in children aged 2-12. This trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), will commence in the Democratic Republic of Congo and Uganda later this year. The goal is to support regulatory approval of MVA-BN in African countries where mpox remains endemic.

Paul Chaplin, President and CEO of Bavarian Nordic, highlighted the urgency of broadening vaccine access for children and adolescents, who are disproportionately affected by the current mpox outbreak in Africa. He emphasized the importance of the NIH's study and expressed confidence in the vaccine's efficacy and safety for both adolescents and adults.

The MVA-BN vaccine, known as IMVANEX® in the EU, IMVAMUNE® in Canada, and JYNNEOS® in the U.S. and Switzerland, is a non-replicating smallpox vaccine. It is the only mpox vaccine approved in these regions. Originally developed in collaboration with the U.S. government to ensure a secure smallpox vaccine supply, it is suitable for immunocompromised individuals who cannot receive traditional replicating smallpox vaccines. The vaccine is currently indicated for adults at risk of smallpox or mpox.

During the 2022-2023 mpox outbreak, the vaccine also received an Emergency Use Authorization from the U.S. FDA for both pre- and post-exposure use in adolescents. Bavarian Nordic has been a longstanding supplier of MVA-BN to the U.S., Canada, and several other countries, contributing to national biological preparedness. Throughout the outbreak, Bavarian Nordic expanded access to the vaccine, reaching over 70 countries worldwide.

As a fully integrated vaccine company, Bavarian Nordic remains committed to protecting and saving lives through its innovative vaccines. The company continues to be a global leader in smallpox and mpox vaccines, working with governments to enhance public health preparedness.