An experimental Ebola vaccine has moved a step closer toward U.S. approval, following the Food and Drug Administration’s acceptance of an application from Merck & Co. for the treatment, dubbed V920.U.S. regulators granted Merck’s application a speedy review, setting up a potential approval decision by March 14, Merck said Tuesday. The pharma is also waiting for regulatory clearance of a German production site that it will use to make commercial doses of the vaccine. More than 2,000 people have died from Ebola in an outbreak that began in The Democratic Republic of the Congo and is now the second largest epidemic of the virus on record. More than 3,000 infections have been confirmed since declaration of the outbreak on Aug. 1, according to numbers kept by the World Health Organization.
While Merck’s Ebola vaccine isn’t yet approved in the U.S. or Europe, the drugmaker has been providing extensive supplies of investigational doses at the request of the WHO.
According to the company, Merck has shipped more than 245,000 1 milliliter doses of V920 to the international health agency, with another 190,000 available.
V920 is part of the international community’s response to the outbreak of Ebola in the northwest corner of the DRC. The number of reported cases per week has come down from a peak several months ago, but remains high.
“While the intensity of the outbreak shows signs of easing in some areas and total case numbers are decreasing, it is too soon to tell if this trend will continue,” the WHO noted in its Sept. 10 situation report.
As the outbreak persists, Merck has begun preparation to increase supply of investigational V920 in consultation with the WHO, the U.S. Department of Health and Human Services and Gavi, the Vaccine Alliance. Merck aims to produce 650,000 doses in phases over the next six to 18 months.
V920 could be approved in the U.S. by then, following the FDA’s grant of priority review. Regulators in Europe are also examining an application from Merck for the vaccine.
Merck’s development of V920 has come with substantial financial support from the U.S. government, which through HHS has put up $176 million to fund development and manufacturing of V920.
According to preliminary data from the WHO, V920 appears effective at protecting individuals from Ebola. Among more than 93,000 at risk individuals vaccinated with Merck’s treatment, only 71 contracted the virus and most of the cases involved onset of symptoms before the time in which a vaccine would be considered effective.
V920’s original developer isn’t Merck, however. The vaccine was originally designed by scientists at Canada’s National Microbiology Laboratory, which licensed the treatment to biotech company NewLink Genetics. That company then out-licensed V920 to Merck in late 2014, when a separate outbreak of Ebola was raging in western Africa.