MedWatch

Bavarian Nordic is working with EMA on monkeypox vaccine label expansion

Bavarian Nordic’s smallpox vaccine Imvanex has previously been used off-label to protect close contacts from monkeypox in several countries. The Danish vaccine firm is now working with the EMA to expand the label in an ”accelerated process.”

Photo: Bavarian Nordic / PR

On Tuesday the EMA announced that it had started assessing whether Bavarian Nordic’s smallpox vaccine could be used to combat the ongoing monkeypox outbreak in Europe.

The statement from the EMA mentioned that the authority was waiting for a formal label expansion application for the vaccine, which is called Imvanex in the region.

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