- Bavarian Nordic’s smallpox vaccine Imvanex has been approved for protection against monkeypox.
- The European Commission has extended marketing authorization for the vaccine to protect against the disease.
- The approval also covers Iceland, Liechtenstein, and Norway as well as the United States.
“The European Commission has extended the marketing authorization for the company’s smallpox vaccine, Imvanex, to include protection from monkeypox,” according to a statement issued by Bavarian Nordic.
“The approval… is valid throughout the European Union, as well as in Iceland, Liechtenstein, and Norway.”
The WHO declared the monkeypox outbreak, which has affected nearly 16,000 people in 72 countries, a global health emergency on Saturday, the highest level of alert.
Imvanex has been approved in the EU for the prevention of smallpox since 2013.
Because of the similarity between the monkeypox virus and the smallpox virus, it was also considered a potential vaccine for monkeypox.
Smallpox, which was eradicated in 1980, is less dangerous and contagious than monkeypox.
During the first five days, monkeypox symptoms include fever, headaches, muscle pain, and back pain.
Rashes appear on the face, palms of the hands, and soles of the feet, followed by lesions, spots, and finally scabs.
Since early May, there has been an increase in monkeypox infections outside of the West and Central African countries where the disease has long been endemic.
The EMA conducts scientific assessments of drugs and makes recommendations on whether or not they should be marketed.
However, under EU law, the EMA lacks the authority to actually allow marketing in the various EU countries. The authorising body is the European Commission, which makes a legally binding decision based on the EMA’s recommendation.
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