Bavarian Nordic seeks vaccine approval for teens

Bavarian Nordic is requesting the authorization of its mpox vaccine, Imvanex, for 12 to 17-year-olds from the European Medicines Agency (EMA) based on data from a clinical trial. Currently, the vaccine is approved for adults and is the only one sanctioned for mpox by EMA and FDA. The World Health Organization (WHO) recently declared a global health emergency due to mpox, formerly known as monkeypox, after an outbreak in the Democratic Republic of Congo spread to neighboring countries. Sweden confirmed a more severe variant of mpox. In a trial with 315 adolescents and 211 adults, the vaccine was effective in both groups with a similar safety profile. Bavarian Nordic also plans to start a trial to assess the vaccine’s efficacy in children aged 2 to 12 later this year in DR Congo and Uganda. The company’s stock has seen a significant increase amid news of mpox spread.