The European Commission has approved the Imvanex vaccine, produced by the Danish biotech 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, the health body’s highest level of alert. Cases of the virus have risen to more than 16,000 in more than 75 countries, the health authority said.
“Having an approved vaccine can greatly improve the preparedness of nations to fight emerging diseases, but only through investment and structured biological preparedness planning,” the company’s chief executive Paul Chaplin said in an interview with Reuters.
So far, Bavarian’s vaccine has only been approved to treat monkeypox in the United States and Canada, where the product is known as Jynneos or by its generic name MVA-BN. It has officially only been used within the European Union to treat smallpox, although Reuters noted that Bavarian had already supplied the vaccine to some EU countries during the monkeypox outbreak for so-called “off-label” use.
According to health analytics company Airfinity, Bavarian has an annual capacity of nearly 40 million injections, and several countries have placed new orders this year. It says the U.S. received 13 million doses in 2022.
Chaplin said the company is in talks to potentially expand production capacity. “We will only push that button if and when the outbreak spreads further and/or demand in terms of volume increases significantly,” he said.
The European Medicines Agency said last month that because there were limited supplies of Imvanex in the EU, its emergency task force recommended that Jynneos be used to prevent monkeypox. The agency said that would allow national authorities to decide, as an interim measure, to import Jynneos from the US to help deal with rising infection rates.
In a statement, Bavarian Nordic said that Imvanex is now authorized 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 worldwide, except in Europe, where the risk was high. It says anyone can contract monkeypox, but cases of this outbreak have been identified mostly in men who have sex with men.
The committee described the surge in monkeypox cases outside Africa, where the virus is endemic, as an “extraordinary event” that required a coordinated global response, and called on countries to step up surveillance and public health measures.
WHO Director-General Tedros Adhanom Ghebreyesus called on organizations to fight stigma and discrimination related to the epidemic.
“With the tools we have now, we can stop transmission and get this outbreak under control,” he said.
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