Merck & Co.’s Application for Ebola Vaccine Accepted by FDA and Granted Priority Review

September 19, 2019

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

On Sept. 17, 2019, Merck & Co., known as MSD outside the United States and Canada, announced that FDA has accepted the biologics license application (BLA) and granted priority review for Merck’s investigational Ebola vaccine (V920) for the prevention of disease caused by the Ebola Zaire virus. FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date for March 14, 2020. In July 2016, FDA granted the vaccine breakthrough therapy designation.

“Merck has worked with government partners and the global health community to accelerate development of our investigational V920 Ebola vaccine. FDA’s priority review designation underscores our long-standing partnership with the US government toward its development and licensure,” said Dr. Paula Annunziato, vice-president, Merck Research Laboratories, in a company press release. “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 [FDA] throughout the review process.”

In parallel to its regulatory efforts, Merck intends 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 1.0-mL 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 1.0-mL 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 V920 Ebola vaccine supply, based on ongoing consultations with the US Department of Health and Human Services, WHO, and Gavi (the Vaccine Alliance). The strategy targets production of an additional estimated 650,000 1.0-mL investigational doses to be released and made available in a phased manner over the next six-to-18 months. In total, past, current, and upcoming production will amount to more than 900,000 1.0-mL investigational doses of V920. Stockpiles are inherently dynamic, however, and thus these estimates are accurate as of the time of this statement. However, estimates are 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 United States. While the company continues to explore opportunities to accelerate production, its timing estimates are based on 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,” Annunziato added in the press release.

Source: Merck & Co.