Imvanex to include protection from monkeypox and diseases caused by vaccinia virus

Bavarian Nordic has announced that the European Commission (EC) has extended the marketing authorization for the company’s smallpox vaccine, Imvanex. The treatment will also 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) – is valid in all EU Member States as well as in Iceland, Liechtenstein and Norway.

The label extension was approved after submission of a rolling type-2 variation application in June 2022, in alignment between Bavarian Nordic and the European Medicines Agency’s Emergency Task Force.

Meanwhile, the EC approved the full Imvanex indication as an active immunisation against smallpox, monkeypox and disease caused by vaccinia virus in adults. The rapid monkeypox indication approval reflects the cooperation between Bavarian Nordic and the European regulators – an indication extension of this nature normally takes at least six to nine months to achieve.

Paul Chaplin, president and chief executive officer of Bavarian Nordic, commented: “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 US government for the past two decades, leading the way for other governments to develop plans and prioritise 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,” he added.

Imvanex is a non-replicating smallpox vaccine developed in collaboration with the US government to ensure supply of a smallpox vaccine for the entire population, including immunocompromised individuals who are not recommended vaccination with traditional replicating smallpox vaccines.