25 July 2016 - Merck today announced two regulatory milestones for the company’s investigational vaccine for Ebola Zaire, V920 (rVSV∆G-ZEBOV-GP, live attenuated): the U.S. FDA has granted the vaccine candidate breakthrough therapy designation, and the EMA has granted PRIME (PRIority MEdicines) status.

PRIME is an approach from the EMA to enhance support for the development of medicines that target an unmet medical need. PRIME is intended to optimize development plans and speed up assessment of the medicine’s application so these medicines may potentially reach patients earlier. PRIME focuses on medicines that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options. These medicines are considered priority medicines by EMA. To be accepted for PRIME, a medicine has to show its potential to benefit patients with unmet medical needs based on early clinical data.

“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, M.D., vice president for clinical research, Merck Research Laboratories.

Read Merck press release