JAKARTA - Danish biotechnology company Bavarian Nordic said on Monday the European Commission had granted 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 warning, declaring the fast-spreading monkeypox outbreak a global health emergency.
"Availability of approved vaccines can significantly increase a country's readiness to combat emerging diseases, but only through investment and structured planning of biological readiness," said Bavarian Chief Executive Paul Chaplin.
The Bavarian vaccine, the only one that has won approval for monkeypox prevention in the United States and Canada, is so far only approved in the European Union to treat smallpox.
However, the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for what is known as "off-label" use.
The agreement applies in all EU Member States as well as in Iceland, Liechtenstein and Norway, the Bavarian Nordic said in a statement.
The development of Imvanex was made possible through significant investments from the US government over the past two decades, the company added.
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