The Danish pharmaceutical company Bavarian Nordic has received approval from the European Commission to expand the marketing authorization of the company's smallpox vaccine, Imvanex, to include protection from monkeypox.
The Imvanex vaccine – developed in collaboration with the United States Government – was first approved by the EU in 2013 for immunization against smallpox in adults aged over 18.
While the Imvanex vaccine has been used to treat smaller outbreaks of monkeypox in the recent past, the latest authorization from the EU means Bavarian Nordic can produce more vaccines and market them to a wider customer base.
The decision applies to all EU Member States, plus Iceland, Liechtenstein and Norway.
"We are pleased to receive the approval from the European Commission, broadening the label of our vaccine to include monkeypox," said Paul Chaplin, President and CEO of Bavarian Nordic. "An approved vaccine can significantly improve nations’ readiness to fight emerging diseases."
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The market approval comes in the context of the World Health Organization (WHO) classifying monkeypox as a public health emergency of international concern – especially in Europe. Over 16,000 cases have now been detected.
" The WHO’s assessment is that the risk of monkeypox is moderate globally and in all regions, except in the European region where we assess the risk as high," WHO Director-General Tedros Adhanom Ghebreyesusm said on 23 July.
On Friday, the European Medicines Agency (EMA) approved extending the smallpox vaccine for use against monkeypox.
Monkeypox is considered to be less dangerous and less contagious than human smallpox, which was eradicated in 1980. The virus is passed from animals to humans and appears as sores on the body. Human to human infection can take place when one comes into contact with bodily fluid, lesions on the skin, respiratory droplets or contaminated surfaces.
