January 15, 2020

A vaccine against the most deadly strain of Ebola virus meets international agencies’ standards, giving hope it could reduce the toll of outbreaks.

World Health Organization officials said Nov. 12, 2019, that Merck’s injectable human-use vaccine against Ebola Zaire virus meets the organization’s standards for quality, safety, and efficacy. That determination lets United Nations’ agencies and the organization Gavi, the Vaccine Alliance, buy it for use in at-risk countries.

One day earlier, Merck officials announced that the European Commission had granted a conditional marketing authorization for the vaccine, which allows its use in European Union countries.

In an announcement, WHO Director-General Tedros Adhanom Ghebreyesus called the WHO’s declaration a historic step.

“Five years ago, we had no vaccine and no therapeutics for Ebola,” he said. “With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”

Kenneth C. Frazier, chairman and CEO of Merck, said in a company announcement that the vaccine, Ervebo, is a product of unprecedented collaboration and should be a global source of pride. He noted that the vaccine is under review by other agencies, including the U.S. Food and Drug Administration.

“We at Merck are honored to play a part in Ebola outbreak response efforts and we remain committed to our partners and the people we serve,” he said. “We also look forward to continuing to work with the FDA and the African countries on their regulatory reviews over the coming months and with the World Health Organization on vaccine prequalification, which will help broaden access to this important vaccine for those who need it most.”

Merck will make the vaccine at a plant in Germany, and licensed doses will be available starting in the third quarter of 2020, the company announcement states.