22/07/2022 (Agence Europe) – The European Medicines Agency (EMA) has announced that it is recommending an extension of the indication for Imvanex vaccine developed by Bavarian Nordic A/S to include protecting adults from the monkeypox disease. Ankara’s modified live vaccine had a marketing authorisation since 31 July 2013 for use in the prevention of smallpox. The EMA states that the recommendations of the Committee for Medicinal Products for Human Use are based on data from studies that have shown protection against monkeypox in non-human primates vaccinated with Imvanex. The effectiveness of Imvanex in humans can be inferred from these studies, according to the EMA. In order to confirm this effectiveness, Bavarian Nordic will need to collect data from an observational study that will be carried out during the ongoing monkeypox outbreak in Europe. (EV)