LONDON—The European Medicines Agency said Friday that the smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox.
The European Union drug regulator said its recommendation was based on animal studies that suggest the vaccine protects non-human primates from monkeypox. It is up to the EU’s executive arm, the European Commission, to formally approve the vaccine based on the EMA’s recommendation.
“To confirm the effectiveness of the vaccine against monkeypox, the company will collect data from an observational study that will be carried out during the ongoing monkeypox outbreak in Europe,” the EMA said. It added that the vaccine’s safety profile was “favorable” and the benefits of its use during the ongoing monkeypox outbreak outweighed the risks, noting mostly mild to moderate side effects….