Merck Receives Breakthrough Therapy Designation for Ebola Vaccine

Although a number of pharma companies are developing vaccines for Ebola, including GlaxoSmithKline and Johnson & Johnson, Merck announced on July 25, 2016 that it has received a Breakthrough Therapy designation from FDA for its investigational vaccine for the virus. The candidate also got a Priority Medicines (PRIME) status from the European Medicines Agency (EMA). Both of these designations may serve to boost Merck’s version through the regulatory process for an earlier decision.

The vaccine candidate V920 is the product of a collaboration of Merck and NewLink Genetics. NewLink received $26.1 million of additional funding in April 2016 from the Biomedical Advanced Research and Development Authority (BARDA) of the United States Department of Health and Human Services (HHS) to conduct clinical bridging studies. Overall, BARDA has invested $74.6 million in the NewLink/Merck project since 2014, and the candidate now has a performance period until October 11, 2017, according to NewLink.

In a Lancetstudy in 2015, those who were immediately vaccinated with Merck’s investigational agent were 100% protected from the virus. The study demonstrated that the vaccine is most likely effective when delivered via a ring vaccination strategy.