Bavarian Nordic Seeks EMA Approval for Pediatric Mpox Vaccine

Bavarian Nordic has formally submitted clinical data to the European Medicines Agency (EMA) to extend the indication of its MVA-BN mpox and smallpox vaccine to children aged 2 to 11 years. The submission is supported by clinical trial results demonstrating a comparable safety profile and a non-inferior immune response in children when compared to adult populations. Currently, the vaccine is only approved for use in adults across Europe, the United States, and Canada. This regulatory move aims to address critical public health needs by providing protection to younger age groups. For investors, this represents a significant milestone that could expand the addressable market for the company's core vaccine product. The EMA's review will determine the potential for a broader rollout in the European market, marking a key step in the company's pediatric clinical program.

Sources:globenewswire.comguidetocanaryislands.comlifescivoice.com