The World Health Organization on Tuesday announced it has prequalified Merck’s Ebola vaccine, reported Healio. The WHO’s nod gives the vaccine a stamp of approval as a safe and effective prevention tool against the deadly virus.
The prequalification means the vaccine meets the WHO’s quality, safety, and efficacy standards, paving the way for United Nations agencies and Gavi, the Vaccine Alliance, to buy the vaccine for use in at-risk countries. Developing countries often use WHO prequalification as guidance when they make their own decisions about whether to license a product.
“This is a historic step toward ensuring the people who most need it are able to access this life-saving vaccine,” Tedros Adhanom Ghebreyesus, WHO Director-General, 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.”
On Monday, the European Commission also granted marketing authorization to Merck’s vaccine, known as Ervebo, less than a month after the European Medicines Agency recommended it be licensed.
The Ebola virus causes haemorrhagic fever and spreads from person to person through direct contact with body fluids.
Notably, Merck’s vaccine is the only one that has been tested during the Ebola outbreak in the Democratic Republic of Congo, where it was shown to be highly effective in preventing infection.
The outbreak has killed some 2,000 people since it started last year making it the second-largest Ebola outbreak in history, after the 2013-2016 epidemic in West Africa that killed more than 11,300.
The Ervebo vaccine protects against Ebola virus disease caused by the Zaire species of the virus, which is the cause of most Ebola outbreaks. It is also being reviewed by U.S. health regulators and a decision is expected in the first quarter of next year.
