(RTTNews) - Bavarian Nordic A/S (BAVA) Thursday said that the European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation for the approval of a type II variation for IMVANEX smallpox and mpox vaccine. This extends the current marketing authorization to include adolescents 12 to 17 years of age.
The approval represents the second EMA approval of an MVA-BN-based vaccine for a younger population
The CHMP recommendation follows the submission last month to EMA of data from a clinical study in 315 adolescents 12-17 years of age and 211 adults aged 18 years and older. The results demonstrated 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.
Paul Chaplin, President & CEO of Bavarian Nordic, said: "We applaud EMA for their expedited review and decision to recommend approval of MVA-BN for adolescents. 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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