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Bavarian Nordic receives approval of extension of vaccine label to include monkeypox

Paul Chaplin

The European Commission (EC) has extended the marketing authorization for the company’s smallpox vaccine, IMVANEX to include protection from monkeypox and disease caused by vaccinia virus.

The approval, which follows a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) on July 22, 2022, is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.

“We are pleased to receive the approval from the European Commission, broadening the label of our vaccine to include monkeypox. The availability of an approved vaccine can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness. The development of IMVANEX was made possible through significant investments from the U.S. government for the past two decades, leading the way for other governments to develop plans and prioritize for the future to protect their citizens against public health threats. With this approval, we look forward to working closer with the EU and its member states to solve this important task,” says Paul Chaplin, President and CEO of Bavarian Nordic.

A rolling type-II variation application

The label extension was approved after submission of a rolling type-II variation application in June 2022, in alignment between Bavarian Nordic and the European Medicines Agency’s Emergency Task Force (ETF), Rapporteurs and the European Health Emergency Preparedness and Response Authority (HERA). The EC approved the full IMVANEX indication as: Active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults. The monkeypox indication approval is an example of great cooperation between Bavarian Nordic and the European regulators as such an indication extension normally takes at least 6-9 months to achieve.

Photo of Paul Chaplin: Bavarian Nordic