EU approves monkeypox vaccine Danish Bavarian Nordic

The European Commission has approved an extension of the Bavarian Scandinavian Pharmaceutical Group’s vaccine against the spread of monkeypox, the Danish lab said on Monday.

The green light from Brussels followed the European regulatory body, the European Medicines Agency (EMA), which on Friday gave its approval to distribute the Imvanex vaccine, already approved since 2013 in the European Union against human smallpox, for monkeypox.

It also comes after the World Health Organization (WHO) decided on Saturday to activate the highest level of alert for a spike in cases. At the end of last week, their number passed the 16,000 mark, with most of them in Europe.

“This monkeypox approval is an example of good cooperation between Bavarian Scandinavian and European regulators, with job extensions typically taking six to nine months,” the Danish manufacturer said in a statement.

The green light from the Commission is valid in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway, the group specifies.

The Imvanex vaccine is sold as Jynneos in the United States, where it has been licensed for monkeypox since 2019. This makes it the only licensed vaccine to prevent this disease.

Bavarian Nordic announced a major new US order in mid-July, bringing the number of doses ordered in the US to 7 million. An order for 1.5 million doses from an unknown European country was also announced last week.

Monkeypox, first identified in humans in 1970, is less dangerous and contagious than the related human smallpox, eradicated in 1980.

When infected through close contact, it usually clears up on its own in two to three weeks.

The disease, until now only endemic in a few African countries, is characterized by a rash that may appear on the genitals or in the mouth and may be accompanied by bouts of fever, sore throat, or pain in the lymph nodes.

In most cases, patients are men who have sex with men, relatively young, but WHO strongly warns against any stigmatization of patients.

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