Bavarian Nordic monkeypox vaccine gets preliminary nod from EU drug regulator

[July 22, 2022]  COPENHAGEN (Reuters) - 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.

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.

An employee of the vaccine company Bavarian Nordic works in a laboratory of the company in Martinsried near Munich, Germany, May 24, 2022. The company, headquartered in Denmark, is the only one in the world to have approval for a smallpox vaccine called Jynneos in the U.S. and Imvanex in Europe, which is also effective against monkeypox. REUTERS/Lukas Barth

"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.

(Reporting by Nikolaj Skydsgaard; editing by Jason Neely)

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