Bavarian Nordic Seeks EU Approval for Expanded Vaccine Use Amid New Mpox Strain

Bavarian Nordic has submitted data to the EU's drug regulator for extending the use of its mpox and smallpox vaccine to adolescents aged 12 to 17. Mpox has been declared a global health emergency, with a new strain identified in Sweden. The company is also planning a clinical trial for children aged 2-12 in Congo and Uganda.

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

The World Health Organization has declared mpox a global public health emergency, noting that children and adolescents are especially vulnerable. On Thursday, global health officials reported a new strain of the mpox virus in Sweden, linked to a growing outbreak in Africa, indicating that the virus is spreading outside the continent.

Paul Chaplin, CEO of Bavarian Nordic, emphasized the critical need for broader vaccine access given that children and adolescents are disproportionately affected by mpox in Africa. The European Medicines Agency's review could lead to an expanded marketing authorization for the vaccine during the fourth quarter, according to the company.

Bavarian Nordic is also planning a clinical trial to test the vaccine's safety in children aged 2 to 12 years. The trial, partly funded by the Coalition for Epidemic Preparedness Innovations, is expected to start later this year in the Democratic Republic of Congo and Uganda.

Since the outbreak began in January 2023, there have been 27,000 cases and over 1,100 deaths, primarily among children, in Congo.

(With inputs from agencies.)