WHO grants approval for use of Bavarian Nordic’s mpox vaccine in adolescents

On 8 October 2024, WHO granted prequalification for the age-extension of the Modified Vaccinia Ankara-Bavarian Nordic (MVA-BN) vaccine for use in adolescents aged 12 to 17 years, expanding its indication to "active immunization against smallpox, mpox and disease caused by vaccinia virus in individuals 12 years of age and older". 

This follows WHO’s decision to add the MVA-BN vaccine to its prequalification list on 13 September, and its assessment of the age-extension data submitted by the manufacturer on 25 September. The European Medicines Agency (EMA) had already recommended extending the vaccine’s indication to adolescents on 19 September 2024. 

Children and adolescents are particularly vulnerable to mpox, facing a higher risk of developing severe mpox disease, which can potentially lead to death. The extended prequalification approval of the MVA-BN vaccine will help expedite the ongoing procurement by governments and international agencies, thereby increasing access to this life-saving product.

Assessing the safety of MVA-BN vaccine in high-risk populations is critically important. WHO recommends further collection of data on vaccine safety and effectiveness for these populations.

More information on MVA-BN vaccine prequalified by WHO can be consulted here.