Three Long Years On… Merck FINALLY Files Its Ebola Vaccine Data With US FDA — Good News…

Back in July of 2016 (as the vintage graphic at right indicates!), Merck won breakthrogh designation for the vaccine candidate — but it has taken three long years to collect the real world data sets, and get organized, for an official FDA approval.

The likely decision date at FDA is now March 14, 2020. It will almost assuredly win approval. Here’s the bit, from FierceBiotech reporting, overnight:

. . . .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 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. . . .

Now you know. This is epidemiologically speaking, doubly good news, as the number of new cases in the DRC are also on a smallish downtrend. Still urgent though, as there have been over 2,000 fatalities, and over 3,100 confirmed cases.


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