Merck's Ervebo Becomes World's First Approved Ebola Vaccine with EU Green Light

Compiled by Fan Dongdong

Since its initial outbreak, Ebola has claimed thousands of lives, and the world finally has an approved Ebola vaccine.

November 11,MSD’s Ervebo (V920) has been approved by European regulatory authorities, becoming the world’s first licensed Ebola vaccine.。

Ervebo is composed of a modified vesicular stomatitis virus (VSV) and an 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.

Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended conditional approval of Ervebo for the prevention of disease caused by the Ebola virus in individuals aged 18 years and older. Prior to approval, due to the severity of the outbreak, MSD responded to the World Health Organization’s (WHO) request by providing substantial quantities of investigational product for administration in the Democratic Republic of the Congo, where the ongoing epidemic has claimed nearly 2,200 lives.

Upon receiving support from the CHMP, Roger Perlmutter, President of Merck Research Laboratories, stated that the company’s “top priority” is to prepare for the planned production of Ervebo. Now that the vaccine has been approved by European regulatory authorities, Merck will commence manufacturing at its facility in Germany, with shipments expected to begin in the third quarter of 2020.

Previously, the U.S. FDA had granted Ervebo Breakthrough Therapy designation and Priority Review status, with a final decision on the vaccine’s marketing authorization expected in March 2020.

In terms of competitors, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, also announced this week that it has submitted two marketing authorization applications to the EMA, seeking approval for its investigational Ebola vaccine regimen for the prevention of Ebola virus disease (EVD) caused by the Zaire ebolavirus strain. In September this year, the CHMP granted accelerated assessment status to these applications.

Reference source: Merck's Ervebo, the world's first Ebola shot, wins inaugural approval in EU