(Illustration Photo: Reuters)

The approval comes just one day after the World Health Organization issued a high-level alert declaring the rapidly spreading monkeypox outbreak as a global health emergency. Bavarian's vaccine, the only one to have won approval for the prevention of monkeypox 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.