EU approves use of Danish monkeypox vaccine

The European Commission has approved the Imvanex vaccine, produced by Danish biotechnology company Bavarian Nordic, to be used as protection against monkeypox.

The decision came a day after the World Health Organization, or WHO, declared the monkeypox outbreak a "global health emergency "of international concern, which is the health body's highest level of alert. Cases of the virus have risen to more than 16,000 in more than 75 countries, said the health body.

"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 company's chief executive Paul Chaplin said in an interview with Reuters.

Until now, Bavarian's vaccine had only won approval as a treatment for monkeypox in the United States and Canada, where the product is known as Jynneos, or by its generic name MVA-BN. It has only been officially used within the European Union to treat smallpox, though Reuters noted that Bavarian has already been supplying the vaccine to some EU countries during the monkeypox outbreak for what is known as "off－label" use.

According to health analytics company Airfinity, Bavarian has an annual capacity of nearly 40 million jabs, and several countries have placed new orders this year. It said the US has received 13 million doses in 2022.

Chaplin said that the company is in talks to potentially expand production capacity. "We'll only push that button" if and when the outbreak spreads further and/or demand in terms of volume increases substantially, he said.

The European Medicines Agency had said last month that as there were limited supplies of Imvanex in the EU, its emergency task force recommended Jynneos be used to prevent monkeypox. The agency said this would allow national authorities who may decide, as a temporary measure, to import Jynneos from the US to help tackle rising rates of infection.

In a statement, Bavarian Nordic said that Imvanex is now permitted for use in all EU member states as well as in Iceland, Liechtenstein, and Norway.

The WHO's emergency committee said it assessed the risk of monkeypox as moderate globally, except in the Europe, where the risk was high. It said anyone can be infected with monkeypox but cases in this outbreak have been mostly identified in men who have sex with men.

The committee described the surge in cases of monkeypox outside Africa, where the virus is endemic, as an "extraordinary event" that requires a coordinated global response, and has urged countries to intensify surveillance and public health measures.

The WHO's director-general, Tedros Adhanom Ghebreyesus, called on organizations to fight stigma and discrimination in relation to the outbreak.

"With the tools we have right now, we can stop transmission and bring this outbreak under control," he said.