EU Drug Regulator Recommends Clearing Vaccine For Monkeypox

LONDON (AP) — The European Medicines Agency has approved the smallpox vaccine made by Bavarian Nordic also against monkeypox, because an outbreak of this once-rare disease is spreading throughout the continent.

European Union drug regulators said their recommendation was based on findings in animal studies suggesting monkeypox vaccines protect nonhuman primates. EMA's recommendation must be formally approved by the European Commission, the EU's executive arm.

Data will be collected from an observational study, which will take place during the current monkeypox outbreak in Europe, to prove the vaccine's effectiveness against monkeypox. A study published last year highlighted the vaccine's "favorable safety profile" and noted that the vaccine's use during the ongoing monkeypox outbreak outweighed the risks, with most side effects being mild to moderate.

As an antimonkeypox vaccine, Imvanex is already approved in the US under the name Jynneos.

Over 30 countries across Europe are affected by monkeypox, with more than 15,000 cases reported worldwide.

There are a limited number of Bavarian Nordic vaccine doses available. In addition to Britain, Canada, the EU, and the US, most of the world's supply has already been purchased. There have been no reports of monkeypox cases in Africa, where a more severe version has caused dozens of deaths. Rich countries have not reported any deaths from monkeypox.

Most monkeypox patients recover within weeks without needing medical attention after experiencing fever, body aches, rash, and lesions.

Health workers and others at high risk of monkeypox infection have been offered the vaccine in a number of countries, including Britain, Germany and the United States.

The appointment system crashed in New York City because of soaring demand for monkeypox vaccine, one of many places where supplies have run out almost immediately.

After congregating its experts for a meeting on Thursday, the World Health Organization will either declare the outbreak a global emergency or not.

Bavarian Nordic monkeypox vaccine gets preliminary nod from EU drug regulator

It was announced on Friday that the European Union's drug regulator had recommended that Bavarian Nordic's Imvanex vaccine be approved for inclusion on its label along with monkeypox protection. Bavarian said the European Medicines Agency (EMA) approved the extension of the company's marketing authorization for its smallpox vaccine, IMVANEX, to include monkeypox protection.

In nearly a decade, a polio case has been found in a suburb of New York CityThe nation's first confirmed case of polio in nearly a decade was confirmed on Thursday in suburban New York City after an adult resident experienced paralysis a month ago.

A New York State Health Department statement indicated the highly contagious and long-feared virus may have originated outside the country in the Rockland County case.

U.S. identifies first cases of monkeypox in children

Health officials announced on Friday that monkeypox has been detected in children for the first time in the United States - a toddler in California and an infant from abroad. According to the Centers for Disease Control and Prevention (CDC), the two cases are unrelated and likely the result of household transmission. According to the agency, the children are in good health and receiving treatment.