Bavarian Nordic, a Danish biotech company, is seeking EU approval to administer the Mpox vaccine to adolescents

Bavarian Nordic is currently in the process of obtaining EU approval to expand the use of its mpox vaccine to adolescents. Further trials are planned for younger children.

Bavarian Nordic, a Danish biotech company, has submitted data to the European Union’s drug regulator in order to request approval to expand the use of its mpox and smallpox vaccine to adolescents aged 12 to 17. This action is a response to the growing threat of mpox, which the World Health Organization has declared a global public health emergency. Children and adolescents are particularly susceptible to this disease.

In a statement, Bavarian Nordic CEO Paul Chaplin underscored the significance and urgency of expanding access to vaccines and therapies for this vulnerable population, as children and adolescents are disproportionately affected by the ongoing mpox outbreak in Africa.

In the fourth quarter of 2024, the company anticipates that the vaccine’s marketing authorization may be expanded to include adolescents, as the European Medicines Agency (EMA) is currently evaluating the submitted data.

Bavarian Nordic is also in the process of conducting a clinical trial to assess the vaccine’s safety in children aged 2 to 12 years, in addition to seeking approval for adolescents. This trial has the potential to further expand the vaccine’s use to lower age groups. As the mpox outbreak persists as a substantial global health challenge, this action serves to emphasize the organization’s dedication to safeguarding the most vulnerable populations.