FDA accepts Merck's BLA and grants priority review for V 920, the investigational vaccine for Ebola Zaire Virus.

Merck Inc., announced that the FDA has accepted the Biologics License Application (BLA) and granted priority review for Merck's investigational Ebola vaccine (V 920), under review for the prevention of disease caused by the Ebola Zaire virus. The Prescription Drug User Fee Act (PDUFA), or target action date, is set for March 14, 2020.

In July 2016, the FDA granted Breakthrough Therapy Designation to V 920. In parallel to its regulatory efforts, Merck has remained steadfast in its commitment to scale-up the number of investigational V 920 Ebola vaccine doses being produced to help international public health officials and government authorities meet ongoing, unpredictable, and evolving outbreak response needs in the Democratic Republic of the Congo (DRC) and neighboring countries. Since May 2018, Merck has donated and shipped more than 245,000 1.0mL investigational V 920 Ebola vaccine doses to the World Health Organization (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 ship to the outbreak region at WHO's request. In addition, in June 2019, Merck started executing an updated replenishment strategy to increase investigational V 920 Ebola vaccine supply, based on ongoing consultations with the U.S. Department of Health and Human Services, WHO and Gavi (the Vaccine Alliance). The strategy targets production of an additional estimated 650,000 1.0mL investigational doses, to be released and made available in a phased manner over the next 6-to-18 months.

In total, past, current and upcoming production will amount to more than 900,000 1.0mL investigational doses of V 920. Stockpiles are inherently dynamic, and therefore all estimates included here are as of the time of this statement and subject to change. New investigational supply will be based on a combination of leveraging material from ongoing production activities at the planned commercial manufacturing site in Germany and new production at a clinical manufacturing site in the U.S. While the company continues to explore opportunities to accelerate production, our timing estimates are based on the need to meet manufacturing and quality-control requirements.

Status of International Regulatory Filings for Merck's Investigational V920 Ebola Zaire Vaccine: In March 2019, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for V 920 for review. In parallel, and in close collaboration with FDA and EMA, submissions have also been made to the WHO to achieve prequalification status and to health authority representatives of the African Vaccine Regulatory Forum (AVAREF).