Monkeypox vaccine gets preliminary approval from the European Medicines Agency

A monkeypox vaccine produced by the Danish biotechnology company Bavarian Nordic has been given preliminary approval by the European Medicines Agency (EMA).

Granted today Friday, July 22 Bavarian Nordic is the only company in the world to manufacture a smallpox vaccine that has also proven effective against monkeypox.

That approval means that the company is now able to supply Imvanex, the smallpox vaccine, as a vaccine for monkeypox.

A statement issued by the company said: “The European Medicines Agency (EMA) had adopted a positive opinion recommending that the marketing authorisation for the company’s smallpox vaccine, IMVANEX, is extended to include protecting people from monkeypox disease.”

The vaccine has already been approved for use in Canada and the US, but up until now, it has not been available for use as a monkeypox vaccine in the EU. In what is known as “off-label” use, some countries within the EU have been using the vaccine in limited amounts for protection against the virus.

With full approval expected shortly, Bavarian Nordic CEO Paul Chaplin said in a statement: “The extension of the label will help to improve access to the vaccine throughout Europe and strengthen the future preparedness against monkeypox.”

The preliminary approval of the vaccine for providing protection against monkeypox will be widely welcomed as numbers continue to grow.

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