The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of the V920 Ebola Zaire vaccine (Ervebo, Merck ), the first vaccine to protect against the Ebola virus disease caused by Zaire Ebola virus in at-risk adults aged 18 years or older.
"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," Guido Rasi, EMA's executive director, said in a news release.
The CHMP's decision is a "triumph for public health, and a testimony to the unprecedented collaboration between scores of experts worldwide," Tedros Adhanom Ghebreyesus, PhD, director-general of the World Health Organization (WHO), said in a news release.
He offered his "deepest gratitude is to the studies' volunteers, researchers, health workers in Guinea, other countries and the Democratic Republic of the Congo who have put themselves at risk to ensure people are protected with this vaccine."
The mortality rate in Ebola patients has varied from 25% to 90% in past outbreaks. The largest Ebola outbreak to date occurred in West Africa in 2014-2016, with more than 11,000 deaths.
The current outbreak in the Democratic Republic of Congo (DRC), which is caused by Ebola Zaire, has a case fatality rate of roughly 67%. More than 3000 people have been infected with Ebola during the ongoing outbreak, which the WHO declared a public health emergency of international concern in July.
Ghebreyesus said that in the current Ebola outbreak in the DRC more than 236,000 people have been vaccinated with Ervebo donated by Merck to the WHO, including more than 60,000 health and frontline workers in the DRC and in Uganda, South Sudan, Rwanda, and Burundi. "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,” Ghebreyesus said.
Ervebo is a genetically engineered, replication-competent, attenuated live vaccine. Data from clinical trials and compassionate use programs have shown that a single dose of Ervebo protects against Ebola virus disease.
The CHMP's recommendation, completed under accelerated assessment, will now be considered by the European Commission, which will issue a final decision.
Ervebo is currently under review by the US Food and Drug Administration (FDA), which granted it breakthrough therapy designation.
Last week, as reported by Medscape Medical News, the FDA approved OraQuick Ebola Rapid Antigen Test (OraSure Technologies), the first rapid diagnostic test to identify Ebola virus antigens, or proteins, in certain body fluids from living and deceased individuals.
Cite this: EU Panel's Thumbs-Up on First Ebola Vaccine a 'Triumph' for Public Health - Medscape - Oct 18, 2019.