Danish shot gets EU nod for monkeypox as WHO declares emergency

A little-known Danish drugmaker won formal approval in the European Union for its vaccine against monkeypox as the World Health Organization declared the outbreak a global health emergency.

Bavarian Nordic A/S’s smallpox vaccine Imvanex got permission to be labelled for monkeypox and another disease caused by the vaccinia virus, the Danish vaccine maker said Monday. The label extension comes after similar clearances in Canada and the US. The stock rose as much as 10 per cent in Copenhagen trading.

Bavarian Nordic receives European approval of extension of vaccine label to include #monkeypox https://t.co/I0nWNb4kIL

— Bavarian Nordic (@BavarianNordic) July 25, 2022

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 and a formal step that helps marshal more resources to curb the outbreak.

Read: WHO declares monkeypox outbreak a global emergency

Bavarian said on Monday that the European clearance, which normally would take six to nine months to obtain, was secured roughly a month after the company submitted an application. The shot was first approved in the region for smallpox in 2013.

The company has already signed several vaccine orders with countries that were using the product off label. Its shares have gained more than 150 per cent since mid-May, when it announced the first such contract. Bavarian has raised its 2022 financial forecast several times and its estimate for full-year revenue is now more than double what it predicted earlier in the year.

The WHO’s decision “raises the prospect of further government orders for Imvanex, the only vaccine currently available,” Peter Verdult, an analyst at Citigroup, wrote in a note. He estimated that at least 50 per cent of Bavarian’s 30-million vaccine dose production capacity could be allocated to the shot.