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EMA starts assessment of Bavarian Nordic's monkeypox vaccine

The European Medicines Agency (EMA) will investigate whether Imvanex, which is already approved for smallpox, can be authorized within the monkeypox indication.

Bavarian Nordic/PR | Photo: LUKAS BARTH/REUTERS / X03379

The EMA has decided to investigate whether Bavarian Nordic’s approved smallpox vaccine Imvanex should also be approved within the monkeypox indication without waiting for an indication expansion application, the authority reveals on its website.

The vaccine is already approved within smallpox and monkeypox in the US under the name of Jynneos, and in Canada under the name Imvamune. Furthermore, several European countries have administered the vaccine off-label within the monkeypox indication.

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