Bavarian Nordic Seeks EU Approval for Adolescent Mpox Vaccine

Danish biotech company Bavarian Nordic has submitted data to the European Union's drug regulator to extend the use of its mpox and smallpox vaccine to adolescents aged 12 to 17 years. Mpox has been declared a global public health emergency by the WHO, particularly affecting children and adolescents.

Danish biotech firm Bavarian Nordic announced on Friday it has submitted data to the European Union's drug regulator, aiming to extend the use of its mpox and smallpox vaccine to adolescents aged 12 to 17 years.

Mpox, declared a global public health emergency by the World Health Organization, poses a heightened risk to children and adolescents. 'Children and adolescents are disproportionately affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden access to vaccines and therapies for this vulnerable population,' stated Bavarian CEO Paul Chaplin.

The European Medicines Agency will review the data, with the possibility of extending the vaccine's marketing authorization by the fourth quarter of the year. Bavarian Nordic is also preparing for a clinical trial to evaluate the vaccine's safety in children aged 2-12 years, potentially widening its use further.