- U.S. and European regulators have agreed to expedite review of Merck's investigational Ebola vaccine, V920, the company said Monday. Merck received a priority review designation from the Food and Drug Administration, and a PRIME status designation from the European Medicines Angency.
- Merck will be submitting data from three clinical trials in New Guinea, Liberia and Sierra Leone, which were all devastated by the Ebola epidemic which infected 30,000 people and killed 11,000 in 2014.
- Merck plans to submit its Ebola vaccine to regulatory authorities on both sides of the Atlantic next year, aiming to win approval and launch V920 by the end of 2017.
The development of an Ebola vaccine has been a coordinated effort between regulatory organizations, public health agencies, and pharmaceutical companies. Merck has been at the forefront of Ebola vaccine development with V920, which it in-licensed from NewLink Genetics and the Health Agency of Canada in 2014.
Last summer, Merck took a huge step forward towards gaining approval for its vaccine when it released interim phase 3 results from a World Health Organization (WHO)-sponsored ring vaccination study. In the 4,000-person study, a single dose of the vaccine was able to effectively protect patients within six to 10 days of its administration.
The WHO continues to play a prominent role in advancing the development of Merck's vaccine and is leading a study of V920 in New Guinea. Elsewhere, the U.S. National Institutes of Health is leading a study trial in Sierra Leone while the Centers for Disease Control and Prevention works on testing in Liberia.
“The granting of Breakthrough Therapy Designation by the FDA and PRIME status by the EMA will enable us to continue to accelerate development of V920, and we greatly appreciate the collaboration of these agencies in moving this vaccine candidate forward in potentially meeting this public health need,” said Paula Annunziato, vice president for clinical research at Merck Research Laboratories.