Approval of Imvanex comes after the World Health Organization declared monkeypox a global health emergency.
Published On 25 Jul 202225 Jul 2022
The European Union’s executive arm has approved a smallpox vaccine for use against monkeypox after the World Health Organization (WHO) declared its spread a global health emergency, the Danish drugmaker that developed the jab said.
“The European Commission has extended the marketing authorisation for the company’s smallpox vaccine, Imvanex, to include protection from monkeypox” in line with a recommendation by the EU’s medicines watchdog, Bavarian Nordic said in a statement on Monday.
“The approval … is valid in all European Union Member States as well as in Iceland, Liechtenstein, and Norway.”
The European Medicines Agency (EMA) carries out a scientific assessment of drugs and gives a recommendation on whether any medicine should be marketed.
However, under EU law the EMA has no authority to actually permit marketing in the different countries in the bloc. It is the European Commission which is the authorising body and takes a legally binding decision based on EMA’s recommendation.
Bavarian’s share price has risen by 122 percent in the past three months, driven by strong demand for the monkeypox vaccine.
Chief Executive Officer Paul Chaplin said the availability of an approved vaccine “can significantly improve nations’ readiness to fight emerging diseases, but only through investments and structured planning of the biological preparedness”.
On Saturday, the WHO declared the monkeypox outbreak, which has affected some 16,000 people in 75 countries, to be a “public health emergency of international concern” – the highest alarm the United Nations’ health agency can sound.
Imvanex 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.
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 the soles of feet, followed by lesions, spots and finally scabs.
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.