The European Union’s medicines regulator said its recommendation was based on animal studies showing the vaccine protects non-human primates from monkeypox. It is up to the EU’s executive arm, 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 conducted during the ongoing monkeypox epidemic in Europe,” the EMA said. He added that the vaccine’s safety profile was “favourable” and the benefits of using it 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, had 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 across 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 territories including Britain, Canada, the EU and the U.S. None has gone to Africa, where a more serious version of monkeypox has killed dozens of people. No deaths from monkeypox have been reported in rich countries. People who contract monkeypox often experience symptoms that include fever, body aches, a rash, and lesions. most recover within weeks without needing medical attention. Authorities in several countries, including Britain, Germany and the US, have offered the vaccine to health workers and those at high risk of contracting monkeypox. In the US, rising demand for the monkeypox vaccine has caused the appointment system to collapse in New York, one of several places where supplies have run out almost as soon as they arrived. The World Health Organization is deciding whether or not to declare the outbreak a global emergency after convening its experts for a meeting on Thursday. The Morning Update and Afternoon Update newsletters are written by Globe editors, giving you a concise summary of the day’s most important headlines. Sign up today.
