COPENHAGEN: Danish biotech company Bavarian Nordic said on Friday (July 22) that the European Union’s (EU) medicines regulator had recommended that its Imvanex vaccine be approved to also include protection against monkeypox in the your label
The European Medicines Agency (EMA) had “adopted a positive opinion recommending that the marketing authorization for the company’s smallpox vaccine, Imvanex, be extended to include protection of people from the disease the monkey pox,” said Bavarian.
The Bavarian vaccine, the only one approved for the prevention of monkeypox in the United States and Canada, has so far only been approved in the EU 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 extension of the label will help improve access to the vaccine across Europe and strengthen future preparedness against monkeypox,” Bavaria CEO Paul Chaplin said in a statement.
The EMA’s recommendation will be forwarded to the European Commission for final approval shortly, the company said.