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In a first, WHO prequalifies Merck’s Ebola vaccine
One day after winning conditional approval in Europe, Merck’s Ebola vaccine received prequalification status from WHO, giving it the agency’s stamp of approval as a safe and effective prevention tool against the deadly virus.
It was the first time WHO prequalified an Ebola vaccine, a process meant to speed up access to medicines. The designation allows United Nations agencies and Gavi, the Vaccine Alliance, to secure the vaccine for at-risk countries, WHO said.
It was the fastest vaccine prequalification process ever conducted by the agency.
“This is a historic step toward ensuring the people who most need it are able to access this life-saving vaccine," WHO Director-General Tedros Adhanom Ghebreyesus, PhD, MSc, said in a statement. "Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable."
The vaccine, named Ervebo, was granted conditional marketing authorization for use in adults on Monday by the European Commission, the executive arm of the European Union, allowing Merck to manufacture doses in Germany. It has already been given to more than 250,000 people in the ongoing Ebola outbreak in the Democratic Republic of the Congo (DRC), where it has been estimated to be more than 97% effective.
The vaccine protects against Ebola virus disease caused by the Zaire species of the virus, which is the cause of most Ebola outbreaks, including the current DRC outbreak and the West African epidemic.
It is also up for FDA approval in the United States, with a decision expected by mid-March.
WHO said it is “facilitating licensing of the vaccine for use in countries at risk of Ebola outbreaks” and has been told that African regulators “will quickly license the vaccine following the WHO recommendation.”