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05 Sept 2025

Smallpox vaccine approved for use against monkeypox virus

Smallpox vaccine approved for use against monkeypox virus

A smallpox vaccine has been approved for use against monkeypox by the European Commission.

The news was confirmed by Danish company Bavarian Nordic. 

It comes just days after the World Health Organization (WHO) declared monkeypox a global health emergency.

“The European Commission has extended the marketing authorisation for the company’s smallpox vaccine, Imvanex, to include protection from monkeypox,”Bavarian Nordic said in a statement.

“The approval… is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway,” it added. 

Paul Chaplin, President and CEO of Bavarian Nordic said: "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," he said. 

In recent days, the World Health Organisation (WHO) said the expanding monkeypox outbreak in more than 70 countries was an “extraordinary” situation that now qualifies as a global emergency.

It was anticipated that the UN health agency’s declaration could spur further investment in treating the once-rare disease – and also worsen the scramble for scarce vaccines.

Although monkeypox has been established in parts of central and west Africa for decades, it was not known to spark large outbreaks beyond the continent or to spread widely among people until May, when authorities detected dozens of epidemics in Europe, North America and elsewhere.

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