The European Medicines Agency (EMA) has approved the use of Bavarian Nordic’s mpox vaccine in adolescents, increasing the chances for its use in this age group in Africa. The label extension is via a type II variation – a route used when a major change is needed in the marketing authorisation for a medicine approved in Europe.

The European Commission on Friday extended the authorization of the Imvanex mpox vaccine to teenagers aged 12 to 17. "Although the overall risk of being infected with mpox for the general EU population remains low,

Bavarian Nordic said on Thursday its mpox vaccine was approved by the EU's drug regulator for use in adolescents, bolstering the case for using the shot in the 12 to 17 age group to contain an outbreak in parts of Africa.

The European Commission has approved Bavarian Nordic's (OTCPK:BVNRY)(OTCPK:BVNKF) mpox shot for adolescents between 12 and 17 years old. Approval was based on data from a clinical study of more than 300 adolescents and 200 adults that found non-inferior immune responses and similar safety profile between both age groups after two standard doses