Bavarian Nordic Receives EMA Approval of Mpox Vaccine for Adolescents [Yahoo! Finance]
BAVARIAN NORDIC R/I S/ADR (BVNRY)
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Source: Yahoo! Finance
Represents the second EMA approval of an MVA-BN-based vaccine for a younger population COPENHAGEN, Denmark, September 19, 2024 – Bavarian Nordic A/S (OMX: BAVA) announced today 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 ® (MVA-BN) smallpox and mpox vaccine, extending the current marketing authorization to include adolescents 12 to 17 years of age. The CHMP recommendation follows the submission last month to EMA of data from a clinical study ( NCT05740982 ), 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. While this represents the
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