Merck's Ebola Vaccine V920 Receives FDA Priority Review with Demonstrated Two-Year Protective Efficacy

Today, MSD announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for the Ebola vaccine V920, indicated for the prevention of disease caused by the Ebola virus. The FDA has also granted V920 Priority Review, with a decision expected by March 14 next year. In March this year, the European Medicines Agency (EMA) had already accepted the regulatory application for V920.

Ebola is a rare virus and a general term used to refer to several species of viruses belonging to the genus Ebolavirus in the family Filoviridae. It can cause Ebola hemorrhagic fever, a severe infectious disease with a high mortality rate. The primary causes of death include stroke, myocardial infarction, hypovolemic shock, or multiple organ failure. During an outbreak in the Democratic Republic of the Congo, more than 2,000 people died from Ebola virus infection. Currently, it has become the second most prevalent epidemic virus worldwide. According to data from the World Health Organization, since the outbreak began in the Democratic Republic of the Congo on August 1, 2018, over 3,000 confirmed cases have been reported.

V920 is composed of a modified vesicular stomatitis virus (VSV) and the important glycoprotein from the surface of the Ebola virus. VSV can cause disease in some livestock but is harmless to humans. The vaccine activates the immune system by producing a mild infection, prompting it to generate antibodies against the Ebola protein. Although V920 has not yet been approved in the United States and the European Union, due to the severity of the outbreak, MSD has responded to the World Health Organization’s (WHO) request by providing a large quantity of investigational product. In response to the unpredictable and evolving needs of the epidemic, MSD has begun preparing to increase the supply of V920 to organizations such as the WHO. In July 2016, the U.S. Food and Drug Administration (FDA) granted V920 Breakthrough Therapy Designation.

▲ Electron micrograph of the Ebola virus (Image source: CDC/ Dr. Frederick A. Murphy [Public domain])

This application is based on clinical data accumulated when V920 was used to protect people in Congo from Ebola virus infection. According to preliminary data from the WHO, V920 may effectively protect individuals from Ebola virus infection. Among more than 93,000 high-risk individuals who received V920 as preventive treatment, only 71 became infected with the virus, and most of those infected had already developed symptoms before the vaccine's protective effect took place.

Furthermore, in a Phase 3, randomized, double-blind, placebo-controlled clinical trial involving 1,197 healthy adults, V920 demonstrated favorable safety and tolerability. A study published in The Lancet indicated that V920 can maintain its protective efficacy for up to two years. In contrast to other Ebola vaccines, whose protective effects last only approximately six months, the long-lasting protection offered by V920 is undoubtedly beneficial for future efforts to combat Ebola outbreaks.

“Collaboration between MSD, governments, and global health organizations has accelerated the development of the Ebola vaccine V920,” said Dr. Paula Annunziato, Vice President of MSD Research Laboratories. “Our immediate priority remains obtaining marketing authorization for V920 and regulatory approval from its German manufacturer to enable subsequent production and supply, thereby supporting global public health objectives. We look forward to continuing our collaboration with the FDA throughout the review process.”

References:

[1] FDA Accepts Merck’s Biologics License Application (BLA) and Grants Priority Review for V920, the Company’s Investigational Vaccine for Ebola Zaire Virus，Retrieved September 17, 2019, from https://www.businesswire.com/news/home/20190917005341/en/FDA-Accepts-Merck’s-Biologics-License-Application-BLA

[2] Merck Official Website，Retrieved September 17, 2019, from https://www.merck.com/clinical-trials/study.html?id=V920-012&kw=Ebola

[3] Six-Month Safety Data of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine in a Phase 3 Double-Blind, Placebo-Controlled Randomized Study in Healthy Adults. Retrieved September 17, 2019, from https://www.ncbi.nlm.nih.gov/pubmed/28549145?dopt=Abstract

[4] Merck's Ebola vaccine tees up FDA date, aiming for first status. Retrieved September 17, 2019, from https://www.fiercebiotech.com/biotech/fda-sets-march-pdufa-date-for-merck-ebola-vaccine

[5] Ebola vaccine from Merck takes step toward US approval. Retrieved September 17, 2019, from https://www.biopharmadive.com/news/merck-ebola-vaccine-fda-priority-review-v920-pdufa/563087/

[6] Merck and NewLink's Ebola Vaccine Leads the Pack in Offering Longest Protection. Retrieved September 17, 2019, from https://www.biospace.com/article/merck-and-newlink-s-ebola-vaccine-leads-the-pack-in-offering-longest-protection/

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