Merck’s late-stage Ebola vaccine has already been deployed against recent outbreaks in the Democratic Republic of Congo. Now, after years of development, the company is ready to seek FDA approval.
Merck on Tuesday said it’s starting a rolling submission for its vaccine, dubbed rVSV∆G-ZEBOV-GP. The process is expected to finish next year.
The rolling submission will allow Merck to submit its application in portions rather than all at once. Merck won the ability to submit its candidate in such a fashion when the agency tagged its vaccine as a potential breakthrough back in 2016.
No vaccines are approved globally for Ebola, but Merck’s shot has been used this year in Congo against new outbreaks. The company licensed its shot from NewLink Genetics and accelerated development in response to an outbreak that killed more than 11,000 people in West Africa in 2014 and 2015. Scientists with Canada’s National Microbiology Laboratory originally developed the vaccine.
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The drugmaker previously said it’d file for approval for the shot last year, but a year ago delayed the filing until 2018. In a previous phase 3 “ring” study targeting people who’ve had exposure to the virus and their contacts, the vaccine demonstrated 100% efficacy.
Under an emergency use authorization, health officials have used the vaccine this year against outbreaks in the Democratic Republic of Congo. The vaccine hasn’t yet won international approvals, but vaccine advisers for the World Health Organization have recommended its use to combat outbreaks when no licensed vaccines are available.
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Aside from Merck, GlaxoSmithKline, Johnson & Johnson, and other smaller biotechs such as Inovio Pharmaceuticals are developing Ebola vaccines.