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

While much of the world has moved on to the latest headline-grabbing outbreak in Zika, Merck continues to press on with its Ebola vaccine candidate. On Monday, the New Jersey pharma announced its rVSV-ZEBOV has won the FDA’s Breakthrough Therapy Designation and the EMA’s Priority Medicines status.

With both designations, the vaccine is set to receive additional regulatory support in its push toward licensure thanks to promising clinical data and a potential to best current Ebola options. Merck plans to submit the vaccine for approval by the end of 2017 as part of a partnership with Gavi that will see the Vaccine Alliance pay $5 million to build a stockpile.

The milestones also come following concerns aired by experts who warned that complacency could lead Ebola vaccine developers to walk away from unfinished projects as the vaccine research community turned to Zika earlier this year. With the deadly Ebola outbreak in West Africa waning in 2015, pharmaceutical companies with promising candidates saw their trial options narrow even as some U.S. federal funding for Ebola was redirected to Zika.

In April, the events led Wellcome Trust Director Jeremy Farrar to declare that, “the job is still not done.” He stressed that complacency could lead to “Ebola vaccine development that is left half-finished.”

Merck is pushing ahead. In a statement, Paula Annuziato, VP for clinical research at Merck Research Laboratories, said the milestones allow the company to “continue to accelerate development”  of the vaccine, “potentially meeting this public health need.”

Aside from Merck, Big Pharma peers GlaxoSmithKline ($GSK) and Johnson & Johnson ($JNJ) also advanced Ebola candidates into Phase III. Novavax, Profectus Biosciences and Inovio have candidates as well. Merck licensed its candidate from NewLink Genetics.

- here’s the release

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