EU Approves Smallpox Vaccine ‘Imanvex’ Against Monkeypox

On Monday, the Danish drugmaker that developed the vaccine said: that the European Commission approved a smallpox vaccine to treat monkeypox after the World Health Organization declared it a global health emergency.

Bavaria Nordic stated: “The European Commission has extended the marketing authorisation of the company’s smallpox vaccine, Imvanex, to include monkeypox prophylaxis, following the recommendation of the EU’s medicines regulator”.

“The approval is valid in all EU member states as well as Iceland, Liechtenstein and Norway.”

On Saturday, the World Health Organisation declared the monkeypox outbreak, which has affected nearly 16,000 people in 72 countries, a global health emergency.

The European Union has approved Imvanex to prevent smallpox since 2013. It is also considered a potential monkeypox vaccine due to its similarity to the smallpox virus.

Monkeypox is less dangerous and contagious than smallpox, eradicated in 1980. The first symptoms of monkeypox are fever, headache, muscle pain, and back pain that last for five days. The rash then appears on the face, palms, and soles, followed by lesions, spots, and finally scabs.

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

The EMA conducts scientific assessments of medicines and recommends whether any medicines should be marketed.

However, under EU law, EMA does not have the authority actually to allow marketing in different EU countries. The European Commission is the authorised body to make legally binding decisions on the advice of the EMA.

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