Danish biotechnology company Bavarian Nordic said on Monday that the European Commission has 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 a day after the World Health Organization issued a high-profile alert declaring the fast-spreading monkeypox outbreak a global health emergency.
“The availability of an approved vaccine can significantly improve the readiness of nations to fight emerging diseases, but only through investments and structured biological preparation planning,” said Bavarian Chief Executive Paul Chaplin.
The Bavarian vaccine, the only one that has gained approval for the prevention of smallpox disease in the United States and Canada, has only been approved in the EU so far 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 EU Member States, as well as Iceland, Liechtenstein and Norway, Bavarian Nordic said in a statement.
The development of Imvanex was made possible through significant investments by the US government over the past two decades, the company added.
Bavarian’s share price has risen 122% in the last three months, driven by strong demand for the smallpox vaccine.
Source: CNN Brasil
