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Bavarian Nordic monkeypox vaccine wins EU approval

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(FILES) This file photo taken on July 13, 2020 shows the company's logo on the headquarters of Danish biotechnology company Bavarian Nordic in Hellerup, north of Copenhagen. Danish company Bavarian Nordic, the lone laboratory manufacturing a licensed vaccine against monkeypox, said on July 19, 2022 an "undisclosed European country" had ordered 1.5 million doses. The World Health Organisation (WHO) has called for "intense" efforts to fight the disease as cases rise, especially in western Europe.
(FILES) This file photo taken on July 13, 2020 shows the company's logo on the headquarters of Danish biotechnology company Bavarian Nordic in Hellerup, north of Copenhagen. Danish company Bavarian Nordic, the lone laboratory manufacturing a licensed vaccine against monkeypox, said on July 19, 2022 an "undisclosed European country" had ordered 1.5 million doses. The World Health Organisation (WHO) has called for "intense" efforts to fight the disease as cases rise, especially in western Europe.
LISELOTTE SABROE / RITZAU SCANPIX / AFP

Danish biotechnology company Bavarian Nordic said on Monday the European Commission had given permission for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended last week by the European Medicines Agency (EMA).

The approval comes just one day after the World Health Organisation issued a high-level alert declaring the rapidly spreading monkeypox outbreak as a global health emergency.

READ | Monkeypox outbreak can be contained, White House says

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 approval is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway, Bavarian Nordic said in a statement.


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