Merck, known as MSD outside the United States and Canada, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a conditional marketing authorization for V920 Ebola Zaire vaccine (rVSVΔG-ZEBOV-GP, live). If affirmed by the European Commission, the vaccine will be authorized under the brand name ERVEBO (pronounced UR-VEE-BOH) and indicated for active immunization of individuals 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. The use of ERVEBO should be in accordance with official recommendations. The CHMP’s recommendation, completed under accelerated assessment, will now be considered by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway. ERVEBO is currently under review in the United States.
“This positive opinion from CHMP represents important progress towards licensure of a vaccine to provide protection from Ebola virus disease to people in areas affected by the Ebola Zaire virus,” said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “Our work would not have been possible without the efforts of countless numbers of people, especially those from the World Health Organization and many other government and non-governmental organizations, who have worked tirelessly on the development of this important vaccine. Our top priority is the achievement of registration of our German ERVEBO manufacturing site, so that licensed supply can be used to support global public health preparedness.”
Status of International Regulatory Filings for V920
In September 2019, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) and granted priority review for V920. The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020. In parallel, and in close collaboration with FDA and EMA, submissions have also been made to the World Health Organization (WHO) to achieve prequalification status and to African health authorities in collaboration with the African Vaccine Regulatory Forum (AVAREF).
On July 25, 2016, Merck announced that the U.S. Food and Drug Administration (FDA) had granted the vaccine candidate Breakthrough Therapy Designation, and that the European Medicines Agency (EMA) had granted PRIME (PRIority MEdicines) status.
The FDA’s Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
PRIME is a process from the European Medicines Agency (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.