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

Merck
Merck's Ervebo, the world's first licensed Ebola vaccine, won European approval Monday. (Merck)

After years in development and outbreaks that have claimed thousands of lives, the world has its first licensed Ebola vaccine. Merck’s Ervebo cleared European regulators Monday, becoming the world’s first vaccine against the disease worldwide. 

The European Commission approved the shot after the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended its approval in October. Even though the vaccine hadn't been approved anywhere in the world before Monday, it had been deployed in Congo, where an ongoing outbreak has killed nearly 2,200 people.

When the drugmaker secured CHMP backing last month, Merck Research Laboratories President Roger Perlmutter said the company’s “top priority” was securing registration for its German plant where it plans to manufacture the vaccine. Now, armed with the approval, Merck can start manufacturing licensed doses at that plant, and it expects to start shipping them in the third quarter of 2020.

Featured Webinar

How to Streamline Your Clinical Research Organization's Processes End to End

Learn how implementing one platform leads to data consistency and ultimately facilitate faster clinical trials while reducing overall trial costs, leave behind spreadsheets and home-grown tools for a predictable trial and the ability to forecast unit delivery resulting in the optics you need to ensure a successful trial, and hear experts share industry trends of what is affecting the Clinical Research Organization industry today.

In the meantime, it's "working closely with the World Health Organization (WHO), the United States Government, and Gavi, the Vaccine Alliance, to ensure uninterrupted access" to the investigational version of the shot to support the Congo outbreak fight.

The Congo emergency is the second deadliest Ebola outbreak in history after a 2014 crisis in West Africa killed more than 11,000 people, sparking a surge of research in the field. 

RELATED: Merck's experimental Ebola shot gets set to fight deadly new outbreak in Congo 

That R&D work eventually led to Merck’s Ebola shot. Researchers at the the Public Health Agency of Canada’s National Microbiology Laboratory originally developed the vaccine and licensed it to NewLink Genetics. Merck licensed the vaccine amid the 2014 outbreak and developed it with numerous partners.

"It is a historic milestone and a testament to the power of science, innovation and public-private partnership," Merck CEO Ken Frazier said in a statement.

In the U.S., the FDA is expected to act on the vaccine in March 2020. 

Suggested Articles

Transporting pharmaceutical products at <-60C for more than 96 hours has seemed an insurmountable challenge. TOWER’s solution has solved the problem.

The countdown to the FDA's first coronavirus vaccine hearing has begun, and new agency documents outline an agenda for the Thursday confab.

Black Americans’ confidence in COVID-19 vaccines is dropping, with only 43% saying they will get a vaccine once it's out—down 22 points since August.