CHMP recommends indication extension for Imvanex for immunisation against smallpox and monkeypox – Bavarian Nordic

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Imvanex, a vaccine for smallpox and monkeypox. The marketing authorisation holder for this medicinal product is Bavarian Nordic A/S. The CHMP adopted an extension to an existing indication, as follows: Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in individuals 2 years of age and older.

Imvanex (MVA-BN or Modified Vaccinia Ankara-Bavarian Nordic) is a non-replicating smallpox vaccine developed in collaboration with the U.S. government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines. The vaccine was approved by the European Commission in 2013 for immunization against smallpox in adults aged 18 years and older and subsequently approvals have been extended to include the monkeypox indication as the only vaccine having obtained this to-date.