Drug Regulators gives preliminary nod for Monkeypox vaccine

The recommendation from the EMA will be referred to the European Commission for final approval shortly, the company said

The Health Master

July 23, 2022

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Last Updated on December 31, 2023 by The Health Master

Bavarian Nordic said the European Union’s drug regulator had recommended its Imvanex vaccine be approved to also include protection against monkeypox on its label.

According to a report by news agency Reuters, 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 protecting people from monkeypox disease,” Bavarian said.

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Bavarian’s vaccine, the only one to have won approval for the prevention of monkeypox disease in the United States and Canada, has so far only been approved to treat smallpox in the EU.

But the company has supplied the vaccine to several EU countries during the current monkeypox outbreak for what is known as “off-label” use, Reuters reported.

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

The recommendation from the EMA will be referred to the European Commission for final approval shortly, the company said, as quoted by Reuters.

(With inputs from Reuters)

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