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Smallpox vaccine approved in EU for use against monkeypox

Imvanex given green light in Europe for use against virus, days after WHO declares global health emergency

The EU's drug watchdog recommended for approval the use of a smallpox vaccine to treat monkeypox on July 22, 2022. (JOE RAEDLE / GETTY IMAGES NORTH AMERICA / AFP)
The EU's drug watchdog recommended for approval the use of a smallpox vaccine to treat monkeypox on July 22, 2022. (JOE RAEDLE / GETTY IMAGES NORTH AMERICA / AFP)

COPENHAGEN, Denmark — The European Commission has approved a smallpox vaccine for use against monkeypox after the World Health Organization declared the virus a global health emergency, the Danish drugmaker that developed the jab said Monday.

“The European Commission has extended the marketing authorization for the company’s smallpox vaccine, Imvanex, to include protection from monkeypox” in line with a recommendation by the EU’s medicines watchdog, Bavarian Nordic said in a statement.

“The approval… is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.”

On Saturday, the WHO declared the monkeypox outbreak, which has affected nearly 16,000 people in 72 countries, to be a global health emergency — the highest alarm it can sound.

Israel has recorded 105 cases of monkeypox so far, and it is expected to begin rolling out its vaccine campaign in the coming days once its first doses arrive.

The rising cases in Israel are raising concerns, as the virus is contagious, and while often mild, can cause serious illness.

A nurse wearing protective gear stands at the entrance of an isolation ward for monkeypox patients at a government hospital in Hyderabad, India, on July 25, 2022. (Noah SEELAM / AFP)

Imvanex has been approved in the EU since 2013 for the prevention of smallpox.

It was considered a potential vaccine for monkeypox because of the similarity between the monkeypox virus and the smallpox virus.

Monkeypox is less dangerous and contagious than smallpox, which was eradicated in 1980.

The first symptoms of monkeypox are fever, headaches, muscle pain and back pain during the course of five days.

Rashes subsequently appear on the face, the palms of hands and soles of feet, followed by lesions, spots and finally scabs.

A test developed by R-Biopharm for research purposes to track and control the spread of the monkeypox virus, June, 1, 2022. (R-Biopharm AG/news aktuell via AP Images)

A surge in monkeypox infections has been reported since early May outside the West and Central African countries where the disease has long been endemic.

The EMA carries out a scientific assessment of drugs and gives a recommendation on whether any medicine should be marketed or not.

However, under EU law the EMA has no authority to actually permit marketing in the different EU countries. It is the European Commission that is the authorizing body and takes a legally binding decision based on EMA’s recommendation.

Times of Israel staff contributed to this report.

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