Bavarian Nordic wins monkeypox vaccine approval in Europe as WHO declares a global emergency

As the monkeypox outbreak rapidly spreads across the world, the World Health Organization (WHO) named the disease a public health emergency and Bavarian Nordic received an extended approval for its vaccine.

Bavarian Nordic's vaccine won an approval to prevent monkeypox after the company only applied for the extended label last month. Bavarian Nordic has already supplied the vaccine, called Imvanex in the EU, to many different, often unnamed, European countries. The vaccine, called Jynneos in the U.S., already had a monkeypox approval in the U.S.

With the WHO declaring the outbreak a public health emergency, Bavarian Nordic’s vaccine is a hot commodity. European regulators approved it to prevent monkeypox much faster than their usual 6- to 9-month review timeline.

Tedros Adhanom Ghebreyesus, the WHO director-general, said in a statement to reporters that he convened a WHO emergency committee to assess the monkeypox outbreak a month ago. At that meeting, the committee determined that the outbreak “did not represent a public health emergency of international concern.”

As the outbreak continued growing, the director-general reconvened the committee to reassess. The committee did not come to a consensus, but Ghebreyesus named the outbreak a national public health emergency of international concern primarily focused on men who have sex with men. The director-general called on civil society organizations to fight stigma and discrimination in relation to the outbreak.

“With the tools we have right now, we can stop transmission and bring this outbreak under control,” Ghebreyesus said.

He recommended a coordinated response to stop transmission and protect vulnerable groups, as well as efforts to protect affected communities. While the WHO assessed that the risk of monkeypox is moderate globally, it is high in Europe.

There are only two other current WHO-designated public health emergencies, COVID-19 and polio. It’s the seventh public health emergency since 2007.