Bavarian Nordic has submitted clinical data to the European Medicines Agency (EMA) to expand the Imvanex (MVA-BN) smallpox and mpox vaccine’s approval to include adolescents aged 12 to 17.
Currently approved only for adults 18 and older, the vaccine was given Emergency Use Authorization by the US Food and Drug Administration (FDA) for adolescents during the 2022 global mpox outbreak.
It remains the only mpox vaccine approved by both the FDA and EMA. It is marketed in the US and Switzerland as Jynneos and in Canada as Imvamune.
The submission to the EMA is based on interim results from a clinical study conducted by the US National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID).
The study involved 315 adolescents aged 12-17 and 211 adults aged 18 and older.
According to the findings, the immune responses in adolescents were non-inferior to those in adults, and the safety profiles were similar after receiving two standard doses of the MVA-BN vaccine.
If the EMA approves the data, the marketing authorisation for Imvanex could be extended to include adolescents by Q4 of 2024, the Danish vaccine company said.
Additionally, Bavarian Nordic is preparing a clinical trial to evaluate the immunogenicity and safety of MVA-BN in children aged two-12.
Funded in part by the Coalition for Epidemic Preparedness Innovations (CEPI), this trial is expected to start later this year in the Democratic Republic of Congo and Uganda.
The results could also support regulatory approval of MVA-BN in African countries where mpox is endemic.
Bavarian Nordic president and CEO Paul Chaplin said: “We applaud the NIH for their work on this study and are pleased to report data that support the use of our vaccine in adolescents, adding to the growing pool of evidence that MVA-BN is well tolerated and able to generate a relevant immune response in adolescent and adult populations.”
In a separate development, Bavarian Nordic announced its plans to ensure a steady supply of vaccines in Africa in response to the mpox outbreak.
The company partnered with Africa Centers for Disease Control and Prevention (CDC) to increase mpox vaccine production in Africa.
The Africa CDC has committed to providing 10 million mpox vaccine doses by 2025.
