Ebola vaccine may be crossing the finish line to approval

The arduous march to an effective vaccine against the Ebola virus has passed an important milestone: the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, (roughly the equivalent of a review panel of FDA), has recommended a conditional marketing authorization for a Merck product, Ervebo (V920, also known as “rVSVAG-ZEBOV-GP, live”). Full approval is expected to follow; Merck also has a BLA application before FDA; a ruling is expected in the spring. Merck currently produces the vaccine at a site in Germany where commercial-scale production is planned; another site in the US will be developed for clinical work.

The World Health Organization hailed the development as a “triumph for public health.” Merck’s president of Merck Research Laboratories, Dr. Roger Perlmutter, called the action “important progress toward licensure,” adding that registration of the German manufacturing site is a next step.

Many groups participated in this project. V920 was initially engineered by scientists from the Public Health Agency of Canada’s National Microbiology Laboratory and subsequently licensed to a subsidiary of NewLink Genetics Corporation. In late 2014, when the Ebola outbreak in western Africa was at its peak, Merck licensed V920 from NewLink Genetics. Along with other collaborators, Merck was supported by funding from the Biomedical Advanced Research Development Authority (Barda) of HHS, as well as parties from Canada, Norway, the UK government, and Médecins Sans Frontières. WHO assisted in organizing a clinical trial in Guinea, along with the Guinea health authorities.

Since May 2018, Merck has donated and shipped more than 245,000 1.0mL investigational V920 Ebola vaccine doses to WHO in response to requests by the WHO. Beyond doses already delivered, more than 190,000 additional 1.0mL investigational doses are currently available and ready to shipped. The breakout in Congo has received much of this inventory.