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Author: Jean-Claude Muller, 穆卓Executive Editor at BtoBioInnovation  jcm9144@gmail.com

SPECIAL REPORT #40

Merck receives European Approval for Ervebo its Ebola Vaccine

On Monday, the European Commission approved Merck’s Ervebo, known as V920, the world’s first Ebola vaccine, just a few days after the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) had recommended the approval.

Although not yet approved the vaccine had already been deployed in Congo, where an ongoing Ebola outbreak has recently killed more than 2,200 people. The securing of the registration allows Merck’s German plant in Burgwedel, to manufacture an estimated additional 650, 000 doses of 1.0 ml of the vaccine and make them available in the third quarter of 2020, to meet the “ongoing , unpredictable and evolving” situation in the Democratic Republic of Congo and neighbouring countries. Merck announced that the company is “working closely with the World Health Organisation, the United States Government and Gavi, the Vaccine Alliance, to ensure uninterrupted access to the investigational version of the vaccine”. The recent outbreak of Ebola in Congo is the second deadliest case in history after the 2014 crisis in West Africa, when more than 28,000 people were infected and over 11,000 died, a humanitarian crisis which triggered a renewed surge for a vaccine.

The current vaccine was originally developed by Dr. Heinz Feldman at Canada’s National Microbiology Laboratory then first licensed to NewLink Genetics and in 2014 when the Ebola spread in Guinea, Sierra Leone and Liberia, Merck took over the development of the product. The European approval “is a historic milestone and a testament to the power of science, innovation and public-private partnership” Merck CEO Ken Frazier said.

Various US authorities have provided a total of $176 million to the development and manufacturing of the investigational vaccine. The US FDA has accepted the biological license application (BLA) for V920, granted it priority review and is expected to approve the vaccine by March 14, 2020.

November 13, 2020

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