Merck announced that the application for Emergency Use Assessment and Listing for its investigational Ebola vaccine has been accepted by WHO for review, a step toward allowing the vaccine to be used during a public health emergency.
V920 is a live-attenuated vaccine that targets the Zaire ebolavirus species, which was responsible for the 2014 Ebola outbreak in West Africa. Engineered by researchers at the Public Health Agency of Canada, the vaccine candidate was initially licensed to NewLink Genetics. In 2014, during the peak of the Ebola crisis, Merck licensed V920 from NewLink to speed up its development and approval. According to Merck, V920 has undergone phase 1, 2 and 3 clinical trials in Africa, the United States, Canada and Europe.
“This application to WHO is an important step toward enabling V920 to be used if a public health emergency of international concern were to be declared for the Ebola Zaire species prior to licensure of the vaccine candidate,” Paula Annunziato, MD, vice president for clinical research at Merck Research Laboratories, said in a press release.
According to WHO, the Emergency Use Assessment and Listing (EUAL) procedures were put in place during the Ebola epidemic to evaluate therapeutic products such as vaccines or diagnostics based on their quality, safety and efficacy, and to accelerate their use in an emergency setting before the products are licensed for commercial distribution. WHO said those same procedures will be extended to future outbreaks that are designated public health emergencies of international concern.
Disclosure: Annunziato is vice president for clinical research at Merck Research Laboratories.