The European Commission approved Bavarian Nordic’s Imvanex vaccine — which protects against smallpox — for use against monkeypox in the EU, the Danish biotech company said on Monday.
Bavarian Nordic said the approval came after “a positive opinion” from the Committee for Medicinal Products for Human Use (CHMP) last week, and is valid in all EU member states.
“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,” Bavarian Nordic’s Chief Executive Paul Chaplin said.
The announcement comes a day after the World Health Organization (WHO) declared the monkeypox outbreak a global health emergency.
Chaplin told Reuters news agency that the company was also in talks to potentially grow production capacity and could meet demand for the monkeypox vaccine in the tens of millions.
What we know about Imvanex vaccine
Imvanex is the only vaccine to have been granted approval for the prevention of monkeypox in the United States and Canada and had previously only been approved for use in the treatment of smallpox.
According to Bavarian Nordic, its jab is a “non-replicating smallpox vaccine” which was developed in collaboration with the US government.
“The development of IMVANEX was made possible through significant investments from the US government for the past two decades,” the company said.
Bavarian Nordic’s share price has risen by 122% over the past three months, driven by strong demand for a vaccine to combat monkeypox.
The disease as long been endemic in West and Central Africa, but spread to countries around the world starting in May this year.
Since then, over 15,300 cases in 75 countries have been confirmed in laboratories, according to the WHO. The current outbreak is centered in Europe.
What are the symptoms of monkeypox?
According to the WHO, those who contract monkeypox report having high fever, an intense headache and swelling of the lymph nodes, as well as back pain and muscle aches.
A skin rash and lesions usually appears 1 to 3 days after the appearance of a fever. The rash most commonly breaks out on the face, but can also appear on the palms of hands and soles of the feet.
Most people recover within weeks without requiring medical attention. Monkeypox is similar to smallpox, but is less dangerous and less contagious.