Danish biotechnology company Bavarian Nordic said on Monday that 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 Organization (WHO) issued a high-level alert declaring the rapidly spreading monkeypox outbreak as a global health emergency.
"The availability of an approved vaccine can significantly improve nations' readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness," Bavarian Chief Executive Paul Chaplin 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.
The approval is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway, Bavarian Nordic said in a statement.
The development of Imvanex was made possible through significant investments from the U.S. government during the past two decades, the company added.
Bavarian's share price has risen by 122 per cent in the last three months, driven by strong demand for the monkeypox vaccine.