Smallpox Vaccine Approved By EU For Use Against Monkeypox
On Monday, the European Commission had approved for a smallpox vaccine, that had been developed by a Danish drugmaker, to be used against monkeypox after the World Health Organisation (WHO) had declared monkeypox a global health emergency.
In a statement that was in line with a recommendation by the EU’s medicines watchdog, Bavarian Nordic said that, “The European Commission has extended the marketing authorisation for the company’s smallpox vaccine, Imvanex, to include protection from monkeypox. 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 that it can sound.
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The EU has approved Imvanex for the prevention of smallpox since 2013. It has also been considered as 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.
Since the beginning of May, a surge in monkeypox infections has been reported outside the West and Central African countries where the disease has long been endemic.
The EMA will carry out a scientific assessment of drugs and then give a recommendation as to whether any medicine should be marketed or not.
However, under the law of the European Union, the EMA does not have the authority to actually permit marketing in the different EU countries. The European Commission is the authorising body and it is the one that takes a legally binding decision based on the EMA’s recommendation.