The FDA has accepted an application for approval of Merck’s Ebola vaccine V920. Merck will learn whether the FDA will approve V920 by mid-March, giving it a shot at becoming the first company to receive clearance to sell a vaccine against the virus in the U.S.
With V920 eligible for priority review, the FDA has set a PDUFA date of March 14. The acceptance of the U.S. filing means V920 is now moving forward on multiple fronts. Merck had an application for approval in Europe accepted for review earlier this year. In parallel, and in collaboration with U.S. and European agencies, Merck has filed for World Health Organization (WHO) prequalification status.
Merck is going to the regulators after generating clinical evidence that V920, also known as rVSV∆G-ZEBOV-GP, has protected people from Ebola in recent outbreaks. In Congo, WHO saw 71 cases among the 93,965 at-risk people who received the vaccine. Most of the cases occurred in the period shortly after vaccination when protection is partial.
The subsequent flurry of regulatory activities is intended to enable Merck to supply licensed vaccines to support global public health preparedness and security efforts. Merck is working to get a German production site cleared to supply the licensed vaccine.
Merck is already supplying the vaccine on an investigational basis, but getting V920 licensed would clear some barriers to access such as the need to obtain informed consent from patients. However, other restrictions on the availability of the vaccine may remain in place regardless of its regulatory status.
Working with WHO, Merck has shipped 245,000 shots of V920 and built a stockpile of 190,000 doses that are ready to send to Congo upon its partner’s request. Merck also aims to release 650,000 doses over the next six to 18 months under its replenishment strategy.
Merck’s ability to ship more vaccines than currently planned is constrained by production capacity. A new clinical manufacturing site in the U.S. will support the German plant. But, while Merck said it is exploring options to accelerate production, it warned its “timing estimates are based on the need to meet manufacturing and quality-control requirements.”
Johnson & Johnson is among the other companies developing Ebola vaccines.