Merck starts rolling FDA submission for its Ebola vaccine, aiming to finish next year

Merck
Merck started a rolling submission for its Ebola vaccine, with the submission expected to complete next year. (Merck)

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.

Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This on-demand webinar discusses the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

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.

RELATED: Merck's Ebola vaccine grabs FDA, EMA milestones in push toward licensure

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.

RELATED: Merck's experimental Ebola shot gets set to fight deadly new outbreak in Congo

Aside from Merck, GlaxoSmithKline, Johnson & Johnson, and other smaller biotechs such as Inovio Pharmaceuticals are developing Ebola vaccines.

Suggested Articles

Alnylam is ready to follow on its Onpattro launch with an FDA nod for Givlaari. But the drug's safety profile is giving analysts reason to pause.

FDA nominee Stephen Hahn faced questions from Senators on Wednesday on topics including drug pricing, biosimilars, opioids and more.

BMS’ Opdivo-Yervoy combo been game-changing in late-stage melanoma. But when it comes to expanding the pair’s reach, the company has hit a roadblock.