Following EMA review use could be approved in Q4 (Il Sole 24 Ore Radiocor) - Copenhagen, 16 Aug - Danish drug company Bavarian Nordic said that it has submitted clinical data to the European Medicines Agency (EMA) to support the extension of the IMVANEX(R) (MVA-BN(R) ) smallpox and mpox vaccine indication to include adolescents 12 to 17 years of age.

The vaccine is currently indicated for adults 18 years and older, but the US Food and Drug Administration granted it an Emergency Use Authorization for use in adolescents during the 2022 global mpox outbreak. It remains the only FDA and EMA-approved mpox vaccine.

The submission is based on interim results from a clinical study, sponsored by the U.S. National Institutes of Health's (NIH) National Institutes of Allergy and Infectious Diseases (NIAID), in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older, 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.

Following review of the data by EMA, the Marketing Authorisation for IMVANEX could be extended to include use of the vaccine for adolescents during the fourth quarter of 2024.

Bavarian Nordic is also preparing for a clinical trial to assess the immunogenicity and safety of MVA-BN in children from 2-12 years of age, aiming to further extend the indication of the vaccine into younger populations.

The trial, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI), is planned for initiation in the Democratic Republic of Congo and Uganda later this year, potentially also supporting a regulatory approval of MVA-BN in African countries, where mpox is endemic.

"Children and adolescents are disproportionally affected by mpox in the ongoing outbreak in Africa, highlighting the importance and urgency to broaden the access to vaccines and therapies for this vulnerable population," said Paul Chaplin, president and CEO of Bavarian Nordic.

MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic is a non-replicating smallpox vaccine and the only mpox vaccine approved in the US and Switzerland, Canada, and the EU/EEA and United Kingdom.

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(RADIOCOR) 16-08-24 08:55:26 (0125) 5 NNNN