EU drug regulator authorise use of Bavarian Nordic's mpox vaccine, Imvanex for adolescents

Bavarian Nordic A/S, a vaccine company focused on protecting lives through innovative vaccines, has announced that the European Commission has approved the Committee for Medicinal Products for Human Use (CHMP) recommendation to expand the use of its Imvanex (MVA-BN) smallpox and mpox vaccine to adolescents aged 12-17. This approval follows an expedited review by the EMA, marking the second EMA approval of an MVA-BN-based vaccine for younger populations.

The decision is based on a recent clinical study involving 315 adolescents and 211 adults, showing comparable immune responses and safety between both groups after two standard doses of the vaccine. Previously, a recombinant version of MVA-BN, Mvabea, was approved by the EMA in 2020 for use against Ebola in individuals as young as one year old.

Bavarian Nordic is preparing to extend the vaccine’s use to children aged 2-12, with trials starting soon, partially funded by the Coalition for Epidemic Preparedness Innovations (CEPI).