EU speeds approval of monkeypox vaccine as WHO declares public health emergency

The European Commission expanded the marketing authorization of Bavarian Nordic’s smallpox vaccine to include use against monkeypox, just days after the EU drugs regulator recommended approval and the World Health Organization declared a public health emergency.

The commission’s OK was faster than the usual one to two months it typically takes to sign off on the European Medicine Agency’s recommendations. The Danish drugmaker’s vaccine, sold as Imvanex in Europe and Jynneos in the U.S., is the front-line defense against the outbreak with an older vaccine limited by side effects and other vaccine options only just entering development.

WHO Director General Tedros Adhanom Ghebreyesus made the decision to issue the UN agency’s highest alert level –  a public health emergency of international concern – for monkeypox on Saturday after its emergency committee failed to reach a consensus on how to respond to 17,000 cases reported so far in 74 countries. 

The declaration acts as a call to action for governments by providing guidance to contain the spread of the disease. “For the moment, this is an outbreak that is concentrated among men who have sex with men, especially those with multiple sexual partners,” Tedros said. “That means that this is an outbreak that can be stopped with the right strategies in the right groups.”

Monkeypox is transmitted between people through close contact, particularly with the characteristic skin lesions that can develop following infection. Transmission can occur via sexual or other physical contact, as well as via body fluids, according to the Centers for Disease Control and Prevention.

Bavarian Nordic said it could run 24-hour shifts to produce 30 million doses per year to meet surging demand, according to a report from Bloomberg. It recently added a U.S.-based contract manufacturer but is trying to avoid tapping other producers because of the cost, delays and difficulty, it said. 

The U.S. has shipped more than 300,000 vaccine doses, with jurisdictions receiving doses typically within 30 hours of ordering, White House Covid-19 response coordinator Dr. Ashish Jha said on a call with reporters Friday. New York City, which has the highest number of cases, has received enough doses to provide a first dose to half its eligible population, while Washington, D.C., has enough for 70% of its eligible population. 

The U.S. has increased monkeypox testing capacity to close to 80,000 per week from about 6,000 when the outbreak began, and has streamlined access to anti-viral treatments such as TPOXX, or tecovirimat, after burdensome paperwork limited access.

“This is not a novel virus. We’ve known about this virus for four decades,” Jha said. “We have built up a lot of capacity to respond and we’re accelerating that to make sure that we are able to put our arms around this virus and really get it fully under control.”

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