Merck’s V920 Ebola Zaire vaccine (Ervebo), has been approved by the European Medicines Agency (EMA) committee as the first vaccine to be administered to provide active immunisation in adults.
Ervebo is a genetically engineered, replication-competent, attenuated live vaccine. The clinical trial data have shown the vaccine to protect against the disease with a single dose.
The vaccine is designed to protect against the Ebola disease caused by Zaire Ebola virus in high-risk adults aged 18 years or older. The EMA Committee for Medicinal Products for Human Use (CHMP) has recommended approval.
“This is an important step towards relieving the burden of this deadly disease. The CHMP’s recommendation is the result of many years of collaborative global efforts to find and develop new medicines and vaccines against Ebola,” said Guido Rasi, EMA’s executive director, in a news release.
The director-general of the World Health Organization (WHO), Dr. Tedros Adhanom Ghebreyesus said that in the current Ebola outbreak in the DRC more than 2,36,000 people have been vaccinated with Ervebo which was donated by Merck to the WHO. More than 60,000 health and frontline workers in the DRC and in Uganda, South Sudan, Rwanda, and Burundi have been vaccinated.
“This vaccine has already saved many lives in the current Ebola outbreak, and the decision by European regulator will help it to eventually save many more,” says Ghebreyesus in the WHO statement.
As of the latest report published by WHO, a total of 3127 confirmed cases of Ebola has been recorded, including 2167 deaths and 1042 survivors.
Ervebo is currently under review by the US Food and Drug Administration, which has granted it breakthrough therapy designation.