Danish pharmaceutical company Bavarian Nordic wants to make its vaccine against mpox available to adolescents aged 12 to 17. The company announced this on Friday. Bavarian Nordic has submitted an application to the European Medicines Agency EMA.
Bavarian Nordic is the only pharmaceutical company that currently has a vaccine against mpox on the market. However, that vaccine, which is marketed in the European Union under the name Imvanex, is only approved for adults, while the recent outbreak also affects children. That is why the pharmaceutical company wants the license to be extended.
The company is providing data from a clinical study involving 315 adolescents and 211 adults, which shows that the vaccine’s effectiveness remains unchanged and that side effects remain the same. Bavarian Nordic hopes to obtain approval for vaccination in adolescents by the last quarter of 2024.
In addition, the pharmaceutical company is also preparing a clinical study in children between the ages of 2 and 12.
The World Health Organization (WHO) declared a global health emergency on Wednesday for the new, more deadly variant of mpox. The outbreak is centered in Congo. A first case in Europe was also reported in Sweden on Thursday.