EU watchdog recommends approving smallpox vaccine for monkeypox

The European Union’s drug watchdog on Friday recommended for approval the use of a smallpox vaccine to treat monkeypox, which could be classified by the World Health Organization as a global health emergency.

“EMA’s human medicines committee (CHMP) has recommended extending the indication of the smallpox vaccine Imvanex to include protecting adults from monkeypox disease,” the European Medicines Agency said in a statement.

Imvanex, developed by Danish drugmaker Bavarian Nordic, has been approved in the EU since 2013 for the prevention of smallpox. 

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

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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.

On Thursday, monkeypox experts discussed whether the WHO should classify the outbreak as a global health emergency — the highest alarm it can sound.

It was the second meeting of the WHO’s emergency committee on the virus and was convened after nearly 15,400 cases have been reported from 71 countries, according to the US Centers for Disease Control and Prevention.

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. 

EMA’s CHMP carries out a scientific assessment of the application and gives a recommendation on whether the medicine should be marketed or not.

However, under EU law the EMA has no authority to actually permit marketing in the different EU countries.

The European Commission is the authorising body and it takes a legally binding decision based on EMA’s recommendation.