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.

With more than 200 mpox-related deaths reported globally, the EMA has approved Imvanex for adolescents aged 12-17 years.

LONDON (Reuters) -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