JAKARTA — Danish biotech company Bavarian Nordic said on Monday that the European Commission has cleared its vaccine Imvanex for marketing as protection against monkeypox, as recommended last week by the European Medicines Agency (EMA).
The approval comes just a day after the World Health Organization (WHO) issued a high-level warning, declaring the fast-spreading monkeypox outbreak a global health emergency.
“The availability of approved vaccines can significantly increase a country’s preparedness to fight emerging diseases, but only through investment and structured biological preparedness planning,” said Bavarian Chief Executive Paul Chaplin.
The Bavarian vaccine, the only one approved for the prevention of monkeypox in the United States and Canada, is so far only approved in the European Union to treat smallpox.
However, the company 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 Iceland, Liechtenstein and Norway, the Nordic Bavarian said in a statement.
The development of Imvanex was made possible by significant investments from the US government over the past two decades, the company added.
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