Bavarian Nordic (BAVA.CO), a Danish biotechnology company, announced on Monday that the European Commission had granted authorisation for its Imvanex vaccine to be marketed as protection against monkeypox, as recommended by the European Medicines Agency last week (EMA).
The decision comes just one day after the World Health Organization declared the quickly growing monkeypox outbreak 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 CEO Paul Chaplin said.
The Bavarian vaccine, the only one approved for the prevention of monkeypox disease in the United States and Canada, has so far only been approved to treat smallpox in the EU.
However, during the current monkeypox outbreak, the business delivered the vaccine to numerous EU countries for “off-label” use.
According to Bavarian Nordic, the approval is valid in all European Union member countries as well as Iceland, Liechtenstein, and Norway.
Imvanex’s research was made possible by major contributions from the US government over the last two decades, according to the business.
The share price of Bavarian has increased by 122% in the last three months, owing to high demand for the monkeypox vaccine.