The European Medicines Agency said on Friday that a smallpox vaccine made by Bavarian Nordic should also be authorized against monkeypox as an outbreak of the once rare disease continues to sicken people across the continent.
The European Union’s medicines regulator said its recommendation was based on animal studies suggesting the vaccine protects non-human primates from monkeypox. It is up to the EU’s executive body, the European Commission, to formally approve the vaccine based on the EMA’s recommendation.
“To confirm the effectiveness of the monkeypox vaccine, the company will collect data from an observational study that will be conducted during the ongoing monkeypox epidemic in Europe,” the EMA said. It added that the safety profile of the vaccine was “favourable” and the benefits of its use during the ongoing monkeypox outbreak outweighed the risks, noting mostly mild to moderate side effects.
The vaccine, known as Imvanex in Europe but sold as Jynneos in the United States, has already been approved for use against monkeypox by US regulators.
Of the more than 15,000 monkeypox cases reported worldwide, nearly 70 percent are in Europe, with more than 30 countries on the continent affected.
The doses of the Bavarian Nordic vaccine are extremely limited. Most of the global supply has already been bought by countries and regions including the UK, Canada, the EU and the US. No one has gone to Africa, where a more severe version of monkeypox has killed dozens of people. No deaths from monkeypox have been reported in rich countries.
People infected with monkeypox often experience symptoms that include fever, body aches, rash, and lesions; most recover within weeks without needing medical attention.
Authorities in many countries, including Great Britain, Germany and the United States, have offered the vaccine to healthcare workers and people at high risk of contracting monkeypox.
In the US, the growing demand for the monkeypox vaccine caused the appointment system to crash in New York, one of many places where supplies ran out almost as soon as they arrived.
The World Health Organization is deciding whether to declare the outbreak a global emergency after convening its experts for a meeting on Thursday.
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