Danish biotech company Bavarian Nordic has submitted data to the European Union’s drug regulator, seeking approval to extend the use of its mpox and smallpox vaccine to adolescents aged 12 to 17 years. This move comes in response to the growing threat of mpox, which the World Health Organisation has declared a global public health emergency, with children and adolescents particularly at risk.

“Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency of broadening access to vaccines and therapies for this vulnerable population,” said Bavarian Nordic CEO Paul Chaplin in a statement.

The European Medicines Agency (EMA) is now reviewing the submitted data, and the company anticipates that the vaccine’s marketing authorisation could be extended to include adolescents during the fourth quarter of 2024.

In addition to seeking approval for adolescents, Bavarian Nordic is preparing to conduct a clinical trial to evaluate the vaccine’s safety in children aged 2 to 12 years, potentially further extending its use to younger age groups. This step underscores the company’s commitment to protecting the most vulnerable populations as the mpox outbreak continues to pose a significant global health challenge.