Bavarian Nordic’s IMVANEX® Vaccine Approved for Adolescents in Europe

Bavarian Nordic A/S (OMX: BAVA) announced that the European Commission has adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation to approve a type II variation for IMVANEX® (MVA-BN), extending its marketing authorization to adolescents aged 12 to 17. This milestone follows the recent submission of data from a clinical study involving 315 adolescents and 211 adults, demonstrating comparable immune responses and safety profiles after vaccination with two standard doses of the MVA-BN vaccine.

This marks the first approval of MVA-BN as a smallpox/mpox vaccine for adolescents, building on previous EMA approval of a recombinant version (Mvabea®) in 2020 for Ebola prevention in individuals aged one and older. With more than 3,300 participants in clinical studies across Europe, the USA, and Africa, the safety profile for Mvabea in children and adolescents has been generally similar to that of MVA-BN.

Paul Chaplin, President & CEO of Bavarian Nordic, emphasized the significance of this approval in improving vaccine access for vulnerable populations affected by the ongoing mpox outbreak in Africa.

The company is also gearing up for a clinical trial to evaluate the vaccine’s safety and immunogenicity in younger children aged 2 to 12, with plans to initiate the study next month. Additionally, a separate study will assess post-exposure vaccination with MVA-BN in children living in households with confirmed mpox cases, potentially shaping future vaccination strategies in outbreak-affected areas.

MVA-BN is the only non-replicating mpox vaccine approved in multiple countries, including the U.S. and EU, initially developed as a smallpox vaccine to ensure safe immunization for all, including immunocompromised individuals. Bavarian Nordic has been a key supplier during the recent mpox outbreak, providing the vaccine to over 70 countries worldwide.