CHMP recommends Imvanex to protect people with monkeypox.
Bavarian Nordic A/S announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that the marketing authorization for the Company’s smallpox vaccine, Imvanex, is extended to include protecting people from monkeypox disease.
Data supporting the positive opinion was submitted upon request from EMA’s Emergency Task Force (ETF) in light of the current multi-country monkeypox outbreak.
The recommendation from the CHMP will be referred to the European Commission (EC) for final approval shortly. Once granted by the EC, the extended marketing authorization will be valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.
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