ERVEBO becomes the first vaccine to be prequalified by the WHO for the prevention of Ebola Virus Disease. WHO prequalification follows the European Commission's grant of a conditional marketing authorization to ERVEBO on November 11, 2019.
ERVEBO is currently under Priority Review with the U.S. Food and Drug Administration (FDA) with a target action date of March 14, 2020.
“WHO prequalification means that ERVEBO has met the WHO's standards of quality, efficacy and tolerability, which, in conjunction with other criteria, offers guidance to the United Nations (UN) and other global health entities in making relevant vaccine decisions. Importantly, prequalification status allows a vaccine to be procured and purchased by the UN, now allowing ERVEBO to be considered as a vaccine to be included in a global Ebola vaccines stockpile being planned by the WHO, UNICEF, Gavi (the Vaccines Alliance), and others,” the company which is known as MSD outside north America said in a statement.
In addition to the submission to the FDA, MSD has also made submissions to selected African country National Regulatory Authorities in collaboration with WHO-AFRO and the African Vaccine Regulatory Forum (AVAREF), which, if approved, will allow the vaccine to be registered in those countries.For more than 100 years, MSD has contributed to the discovery and development of novel medicines and vaccines to combat infectious diseases. In addition to a combined portfolio of vaccines and antibacterial, antiviral and antifungal medicines, MSD has multiple programs that span discovery through late-stage development.
The recent Ebola outbreak in the Democratic Republic of Congo which is the tenth, was confirmed by the country’s Ministry of Health and WHO in August last year and so far there have been 3,287 confirmed cases and 2192 deaths.
In August this year, scientists announced a breakthrough after decades of search for Ebola cure.
The trials which began in November last year involved four drugs but two emerged the most effective.
“From now on, we will no longer say that Ebola is incurable,” said Prof Jean-Jacques Muyembe, General Director of the National Institute for Biomedical Research of the Democratic Republic of the Congo whose institute oversaw the trial. “These advances will help save thousands of lives.”