Bavarian Nordic Submits Data to EMA to Extend Mpox and Smallpox Vaccine Approval to Children Aged 2-11 Years [Yahoo! Finance]
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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Source: Yahoo! Finance
Submission based on topline data from clinical study, demonstrating a comparable safety profile and a non-inferior immune response for MVA-BN in children aged 2-11 years compared to adults. COPENHAGEN, Denmark, March 27, 2026 – Bavarian Nordic A/S (OMX: BAVA) has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the MVA-BN ® mpox and smallpox vaccine indication to include children aged 2 to 11 years. The submission is based on positive topline results from a Phase 2 clinical study ( NCT06549530 ) in 227 children aged 2-11 years and 224 adults demonstrating non-inferiority of the immune responses as well as a similar safety profile, between both age groups after vaccination with two standard doses of the MVA-BN vaccine. The study was co-funded by the Coalition for Epidemic Preparedness Innovations (CEPI) and was conducted at sites in the Democratic Republic of Congo (DRC) and Uganda. Both countries reported cases of mpox in adults and child
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