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EU drug regulator gives preliminary nod to Bavarian Nordic’s monkeypox vaccine

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.

Bavarian Nordic, monkeypox vaccine, IMVANEX, monkeypox outbreak, health news, pharma news,
This 2003 electron microscope image made available by the Centers for Disease Control and Prevention shows mature, oval-shaped monkeypox virions, left, and spherical immature virions, right, obtained from a sample of human skin associated with the 2003 prairie dog outbreak. Israeli authorities said late Saturday, May 21, 2022, they have detected the country's first case of monkeypox in a man who returned from abroad and were looking into other suspected cases. (Image Credit: AP)

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.

According to a report by news agency Reuters, 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, Reuters reported.

“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 as quoted by Reuters.

(With inputs from Reuters)

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