WHO approves Bavarian Nordic’s Mpox Vaccination for Adolescents

WHO approves Bavarian Nordic’s Mpox Vaccination for Adolescents

Highlights

• WHO certified Bavarian Nordic’s mpox vaccine for teenagers aged 12 to 17 years

• Clinical study initiated for children aged 2 to 11, following recent approvals from the EMA and WHO

 

Mpox vaccine receives WHO’s approval

The World Health Organisation (WHO) approved the Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN) vaccine on 8 October 2024 for adolescents aged 12 to 17. This extension broadens its use to protect against smallpox, mpox, and vaccinia virus-related diseases in people aged 12 and over. WHO added the MVA-BN vaccine to its prequalification list on 13 September, after reviewing the manufacturer’s evidence for age extension on 25 September.

Mpox vaccination campaign expands scope

The European Medicines Agency (EMA) had already recommended this indication for teenagers on 19 September 2024. The new prequalification approval will accelerate purchases by governments and international organisations, expanding access to this life-saving vaccine. In supply-constrained outbreaks, WHO advises a single dose but highlights the need for more data on vaccine safety and effectiveness. With prequalification, governments and international organisations can now procure the vaccine for eligible countries.

Mpox vaccination benefits

WHO reports that a single dose of Imvanex before exposure provides an estimated 76% protection against mpox, while a two-dose regimen raises efficacy to 82%. Dr Tedros Adhanom Ghebreyesus, WHO Director-General, underscored the importance of this first mpox vaccine prequalification, calling for urgent efforts in procurement, donations, and distribution. Ensuring equitable access to vaccines and other public health measures will help prevent infections, halt transmission, and save lives. Bavarian Nordic has also started a clinical study of the MVA-BN mpox/smallpox vaccine for children aged 2–11. This study, partially funded by the Coalition for Epidemic Preparedness Innovations, is enrolling participants in the Democratic Republic of Congo and Uganda and will assess the vaccine’s safety and immune response in children compared to adults.

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