Monkeypox vaccine gets preliminary nod from EU drug regulator

Danish biotechnology company Bavarian Nordic said on Friday the European Union’s drug regulator had recommended its Imvanex vaccine be approved to also include protection against monkeypox on its label.

The European Medicines Agency (EMA) had “adopted a positive opinion recommending that the marketing authorisation for the company’s smallpox vaccine, IMVANEX, is extended to include protecting people from monkeypox disease,” Bavarian said.

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Bavarian’s vaccine, the only one to have won approval for the prevention of monkeypox disease in the United States and Canada, has in the EU so far only been approved to treat smallpox.

But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for what is known as “off-label” use.

“The extension of the label will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox,” Bavarian CEO Paul Chaplin said in a statement.

The recommendation from the EMA will be referred to the European Commission for final approval shortly, the company said.