Bavarian Nordic nabs EU approval for monkeypox vaccine as WHO declares global health emergency
As the WHO declared the monkeypox outbreak to be a global health emergency, Bavarian Nordic obtained an expanded European label for its smallpox vaccine to include the surging virus.
The move comes roughly a month after the biotech filed for a label expansion, and after several countries on the continent, and elsewhere, secured their own supply deals for the shot. Bavarian Nordic has said it’s seen “overwhelming” interest in the vaccine, and its stock price $BVRNY has followed in short order — shares are up 124% since the first monkeypox case was detected on May 6.
Monday’s approval will likely help boost supply of the vaccine across Europe just a few days after the WHO raised the monkeypox alert level to its highest classification Saturday, officially declaring the outbreak a global health emergency. There had been more than 17,000 cases around the world as of Saturday, roughly a 50% increase over the last week, with cases in over 75 countries.
“WHO’s assessment is that the risk of monkeypox is moderate globally and in all regions, except in the European region where we assess the risk as high,” WHO director-general Tedros Adhanom Ghebreyesus said in a statement Saturday. “There is also a clear risk of further international spread, although the risk of interference with international traffic remains low for the moment.”
The declaration was a reversal from WHO’s previous stance a month ago, when the WHO declined to elevate the outbreak’s status.
Last week, Europe secured another supply deal for Bavarian Nordic’s shot, ordering 54,000 doses to bring its total stash to 160,000. An initial order of 110,000 shots came in late June, providing more access to the vaccine on the continent where individuals had struggled to get it.
Other countries, too, have been ordering the jab. Canada signed a $56 million contract last month and Bavarian Nordic has previously said it’s been in discussions with countries in Asia, Europe, South America and the Middle East as well.
BARDA, meanwhile, bought 2.5 million doses for the US national stockpile earlier this month, and has said it expects to deliver 1.6 million doses by the end of the year.