MSD's Ervebo (V920) Recommended for Conditional Approval by EMA as First-Ever Ebola Vaccine

Yesterday, MSD announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had recommended conditional approval of its Ebola vaccine Ervebo (V920) for the prevention of disease caused by the Ebola virus in individuals aged 18 years and older. If approved, Ervebo will be the first Ebola virus vaccine to receive global regulatory approval.

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 in humans with a high mortality rate. The main 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.

Ervebo consists of a modified vesicular stomatitis virus (VSV) and the key 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 Ervebo 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 substantial quantities of investigational product. In response to the unpredictable and evolving demands of the epidemic, MSD has begun preparing to increase the supply of Ervebo to organizations such as the WHO.

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

A study published in The Lancet demonstrated that Ervebo can maintain its protective efficacy for up to two years. In contrast to other Ebola vaccines, whose protective effects last only about six months, Ervebo’s long-lasting protection is undoubtedly beneficial for future efforts to combat Ebola outbreaks. Previously, the U.S. FDA had granted Ervebo Breakthrough Therapy designation and Priority Review status, and was expected to respond to its marketing application by March 14 of the following year.

“The CHMP’s recommendation represents a significant step toward Ervebo’s goal of protecting populations potentially affected by the Ebola virus,” said Dr. Roger M. Perlmutter, President of Merck Research Laboratories. “We are deeply grateful to the World Health Organization and many other governmental and non-governmental organizations for their assistance; their tireless efforts have advanced the development of the Ebola vaccine. Our immediate priority is to secure regulatory approval for Ervebo from the German manufacturer, thereby enabling subsequent production and supply to support global public health objectives.”

References:

[1] Merck Receives EU CHMP Positive Opinion for Investigational V920 Ebola Zaire Vaccine for Protection Against Ebola Virus Disease, Retrieved October 18, 2019, from https://www.businesswire.com/news/home/20191018005198/en

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