Merck’s v920 Ebola Zaire Vaccine Granted Priority FDA Review
New Jersey-based Merck announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920).
The V920 vaccine is under review for the prevention of disease caused by the Ebola Zaire virus, said Merck in a September 17, 2019, press release.
This is good news since there is not an FDA authorized preventive vaccine available for the Ebola disease today.
Furthermore, Ebola Zaire outbreaks continue to be reported in Central Africa countries.
Dr. Paula Annunziato, vice president, Merck Research Laboratories, said in this press release, “A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site, so that licensed (vaccine) supply can be produced over time to support global public health preparedness and health security objectives.”
The Prescription Drug User Fee Act (PDUFA) target action date is set for March 14, 2020. Previously, in July 2016, the FDA granted Breakthrough Therapy Designation to the V920 vaccine.
In parallel to its regulatory efforts, Merck has remained steadfast in its commitment to scale up the number of investigational V920 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 V920 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 the investigational V920 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 the 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 V920.
Ebola Zaire news
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.
In March 2019, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for V920 for review. In parallel and in close collaboration with the 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).
V920, Merck’s investigational Ebola Zaire vaccine, 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. Since that time, the company has worked closely with a number of external collaborators to enable a broad clinical development program with partial funding from the U.S. government, including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority and the Department of Defense’s Defense Threat Reduction Program and Joint Vaccination Acquisition Program, among others.
Merck’s V920 investigational supply replenishment activities are supported by partial Federal funding from BARDA under Contract No. HHSO100201700012C.
Merck is responsible for the research, development, manufacturing and regulatory efforts in support of V920. The company has committed to working closely with other stakeholders to accelerate the continued development, production and, if licensed, distribution of the vaccine.
To learn more about Merck’s infectious diseases pipeline, visit Merck.
Ebola news published by Vax-Before-Travel