Bavarian Nordic (BVNKF.PK) has submitted clinical data to the European Medicines Agency (EMA) to support extending the indication of the IMVANEX smallpox and mpox vaccine to include adolescents aged 12 to 17 years. According to the company, the EMA's review of these data could result in the Marketing Authorisation for IMVANEX being expanded to cover adolescent use in the fourth quarter of 2024.
Previously, the vaccine received Emergency Use Authorization from the FDA for adolescent use during the 2022 global mpox outbreak.