Merck announced September 17th that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) and granted Merck’s investigational Ebola vaccine (V920) priority review. The Prescription Drug User Fee Act (PDUFA) target action date is set for March 14, 2020. The FDA granted Breakthrough Therapy Designation to V920 in July 2016.
Merck’s Investigational V920 Ebola Zaire Vaccine is filing necessary documents to be internationally recognized.
In March 2019, the European Medicines Agency (EMA) accepted the Marketing Authorization Application (MAA) for V920 for review. Collaborating closely with FDA and EMA, submissions have also been made to the WHO to achieve prequalification status with health authority representatives of the African Vaccine Regulatory Forum (AVAREF).
Meanwhile, Merck, known as MSD outside the United States and Canada, has sustained its commitment to scale-up the quantity of investigational V920 Ebola vaccine doses it produces in order to help international public health officials and government authorities meet the unpredictable ongoing and evolving need that has arisen since the epidemic outbreak in the Democratic Republic of the Congo (DRC) and neighboring countries.
The Democratic Republic of the Congo is now battling the world’s second-largest Ebola epidemic on record. Declared on August 1st, 2018, the epidemic has claimed more than 2000 lives; there have been 3000 confirmed infections. The outbreak is occurring in North Kivu, South Kivu and Ituri provinces. Neighboring countries are taking steps to mitigate the risk of spread. The World Health Organization has more than 650 staff on the ground supporting the government-led response along with national and international partners.
September numbers reveal a total of 3183 cases (3069 confirmed, with 114 probable cases). There have been 2126 deaths, and there are 981 survivors and patients still under care, according to the Democratic Republic of the Congo’s Ministry of Health.
Merck’s efforts are significant, given the context.
“Merck has worked with government partners and the global health community to accelerate the development of our investigational V920 Ebola vaccine. FDA’s priority review designation underscores our long-standing partnership with the U.S. government toward its development and licensure,” said Dr. Paula Annunziato, Vice-president, Merck Research Laboratories. “A top priority for us remains achieving registration of V920 and regulatory approval of our German manufacturing site so that licensed supply can be produced over time to support global public health preparedness and health security objectives. We look forward to continuing to work with the FDA throughout the review process.”
Responding to requests by the World Health Organization, Merck has donated and shipped, since May 2018, more than 245,000 1.0mL investigational V920 Ebola vaccine doses. Currently, more than 190,000 additional 1.0mL investigational doses are available and ready to ship to the outbreak region at WHO’s request.
Since June 2019, based on consultations with the U.S. Department of Health and Human Services, WHO and Gavi (the Vaccine Alliance), Merck started working on a strategy to boost investigational V920 Ebola vaccine production. According to the new plan, an additional estimated 650,000 1.0mL investigational doses are going to be produced and made available, in phases, over the next 6-to-18 months. The total of past, current and upcoming production will amount to more than 900,000 1.0mL investigational doses of V920.
The new vaccine doses will come both from ongoing production activities at the planned commercial manufacturing site in Germany and the new production at a clinical manufacturing site in the U.S. Although the company continues to seek new ways to increase production, the timing estimates take into account the need to meet manufacturing and quality-control requirements.
“We continue to be proud and humbled to provide our investigational V920 Ebola vaccine as an additional tool in support of the comprehensive public health response efforts against the current Ebola outbreak. Merck appreciates and continues to work closely with our collaborators and is inspired by the relentless determination of everyone involved, especially frontline responders, working to contain this unique and dangerous outbreak,” Dr. Annunziato added.
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. When the Ebola outbreak in western Africa was at its peak in late 2014, Merck licensed V920 from NewLink Genetics. Ever since, the company has worked closely with various external collaborators to ensure the success of a broad clinical development program to create the vaccine. This effort is partially funded by the U.S. government, including the Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA) and the Department of Defense’s Defense Threat Reduction Program (DTRA) and Joint Vaccination Acquisition Program (JVAP), among others. Merck’s V920 investigational supply replenishment activities are supported by partial Federal funding from BARDA under Contract No. HHSO100201700012C. Every aspect concerning the research, development, manufacturing and regulatory efforts in support of V920 are Merck’s responsibility. The company has committed to working closely with other stakeholders to accelerate the development, production and, if licensed, distribution of the vaccine.
For more than 100 years, Merck has worked towards the discovery and development of new drugs and vaccines to fight against infectious diseases. Today, Merck continues the research to advance the prevention and treatment of serious diseases that threaten people around the world – including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease, and infectious diseases, including HIV and Ebola.