Modified vaccinia ankara

Bavarian Nordic seeks to expand MVA-BN mpox/smallpox vaccine approval to children aged 2-11, initiating a Phase II trial funded by CEPI. The trial will compare vaccine safety and immunogenicity between children and adults, with recruitment planned in the Democratic Republic of Congo and potentially Uganda. MVA-BN, marketed as Jynneos in the US and Imvanex in Europe, has been a major revenue driver for Bavarian Nordic, generating DKK5bn ($724m) in revenue last year.

Mpox vaccine (MVA-BN; Jynneos) generated robust immune responses in adolescents, with higher geometric mean titers (GMT) than in adults, and was deemed safe, according to a phase II clinical trial interim analysis presented at IDWeek.

NIH clinical trial shows Bavarian Nordic’s mpox vaccine induces equivalent antibody response in adolescents and adults, potentially supporting extended use in under-18s. The vaccine is already approved for adolescents in Europe but not in the US, where it is only approved for adults. The study found no significant differences in adverse events between age groups, though dizziness was more common in adolescents. Bavarian Nordic plans to conduct a Phase II trial for children aged 2-12, aiming to extend the vaccine’s indication to younger populations.

MVA-BN vaccine showed similar immune response in adolescents and adults with no safety issues in a U.S. phase 2 trial. The vaccine, marketed as Jynneos in the U.S. and Imvanex in Europe, is now approved for adolescents. The WHO has prequalified the vaccine for use in high-risk groups, including infants and pregnant women. Bavarian Nordic plans to trial the vaccine in children aged 2 to 12, and CEPI is funding studies on post-exposure vaccination efficacy.