A little-known Danish drugmaker won formal approval in the EU for its vaccine against monkeypox as the World Health Organisation declared the outbreak a global health emergency.
Bavarian Nordic’s smallpox vaccine Imvanex received permission to be labelled specifically for monkeypox and another disease caused by the vaccinia virus, the Danish vaccine maker said on Monday. The label extension comes after similar clearances in Canada and the US. The stock rose as much as 10% in Copenhagen trading.
Bavarian Nordic’s vaccine is the only one to have won approval for the prevention of monkeypox disease in the United States and Canada and the EU. The vaccine goes by the brand name Jynneos, Imvamune or Imvanex – depending on geography.
Bavarian Nordics has annual production capacity of 30 million doses, including the monkeypox vaccine and other vaccines it makes. That is sufficient to meet current demand for the monkeypox vaccine, Chief Executive Paul Chaplin said in an interview with Reuters.
The company is, however, working with a U.S.-based contract manufacturer to expand its production capacity.
Chaplin said he hoped that process would be completed later this year, and added the company was in early talks with others, including contract manufacturers and other vaccine makers, in case a further expansion is needed.
The global flare-up of monkeypox, which has spread to about 16,000 people in more than 70 countries in just a few months, was elevated to the WHO’s highest level of alert over the weekend as the head of the agency declared it a public-health emergency of international concern — the first such ruling since the coronavirus.
