In September 2024, the European Medicines Agency (EMA) announced its recommendation to extend the indication of the smallpox and mpox vaccine Imvanex to adolescents from 12 to 17 years of age. Imvanex, Bavarian Nordic’s MVA-BN, is authorised in the EU for the protection of adults against smallpox, mpox, and disease caused by the vaccinia virus. The Committee for Medicinal Product for Human Use (CHMP) based this recommendation on interim results from a study comparing the effects of the vaccine in adolescents and adults.
Data-led expansion
Interim results indicate that the immune response in adolescents was comparable to adults, from which the authorities have inferred that the vaccine will “provide similar protection in adolescents to that expected in adults”. The safety profile was also comparable with no additional risk identified. EMA has requested the marketing authorisation holder to submit the results of this study by 30th May 2025 to further characterise the safety information for adolescents.
Although this is the first approval of MVA-BN as a smallpox,mpox vaccine for adolescents, Bavarian Nordic notes that a recombinant version of MVA-BN (Mvabea) received EMA approval in 2020 as part of a prime-boost regimen for the prevention of disease caused by Ebola virus in individuals aged 1 and older. This approval was based on studies involving more than 3,300 individuals, including over 800 children and adolescents aged 1-17 in Africa.
Implications for the response
EMA states that this assessment has “important implications” for the global mpox response. As EMA is the regulatory agency of record for the WHO prequalification of the vaccine earlier this month, the CHMP assessment constitutes the basis for WHO prequalification approval to “facilitate timely and increased access” in communities that need it most. The EMA’s assessment has also previously been considered by the DRC’s national regulatory authority for fast-track approval.
President and CEO of Bavarian Nordic, Paul Chaplin, applauded EMA for the “expedited” review and decision.
“This represents an important milestone in our efforts to make our vaccine available for all populations and will help improve access for some of the most vulnerable individuals mostly impacted by the ongoing mpox outbreak in Africa.”
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