Bavarian Nordic A/S said Friday that it has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency, recommending that marketing authorization for the company’s Imvanex smallpox vaccine be extended to include protection against monkeypox.
The Danish vaccine maker
said the recommendation will be referred to the European Commission for final approval shortly.
Once granted by the European Commission, the extended marketing authorization will be valid in all European Union member states as well as in Iceland, Liechtenstein and Norway, it said.
The vaccine is approved for use against monkeypox by the U.S. and Canada, and Bavarian Nordic has already supplied the vaccine to several European countries. However, Friday’s recommendation will help to improve access to the vaccine throughout Europe and strengthen future preparedness against monkeypox, the company said.
Write to Dominic Chopping at firstname.lastname@example.org