- The Food and Drug Administration has approved Merck & Co.'s vaccine to protect people from the Ebola virus, marking the first approved vaccine for the contagious disease that killed more than 11,000 people in a 2014 epidemic.
- An ongoing Ebola outbreak has drawn the world's attention once again, causing more than 2,000 deaths in the Democratic Republic of the Congo since August 2018. Merck's vaccine, now branded as Ervebo, and other experimental treatments from drugmakers including Johnson & Johnson and Regeneron have been given to thousands of people in the DRC since.
- While Merck's vaccine remains unapproved in Africa, the drugmaker said Friday it has submitted the medicine to African regulators in collaboration with the African Vaccine Regulatory Forum. The European Commission approved Ervebo last month, and countries are expected to stockpile the vaccine to protect against potential bioterrorism attacks.
Merck CEO Ken Frazier has publicly highlighted the Ebola vaccine development as part of the drugmaker's public health duties.
"For efforts such as this there is no commercial opportunity, but we pursue them because these are the challenges that Merck was created to tackle," Frazier said in February in prepared remarks before a Senate committee.
The New Jersey-based pharma giant isn't alone in the endeavor, as there are eight vaccines in various stages of development, according to Gavi, the Vaccine Alliance.
Merck has shipped more than 275,000 doses to the Congo since the outbreak started, and nearly 1,000 people have also received J&J's vaccine as part of a trial.
Data from the local government has shown steady declines in the number of weekly confirmed cases after peaking in the first half of 2019. From Dec. 11-17, health officials in eastern Congo reported 11 new, confirmed cases of Ebola.
The board of Gavi, a nonprofit that receives funding from a wide range of governments, philanthropies and companies, approved a plan earlier this month to stockpile 500,000 doses of Ebola vaccine from now to 2025. It plans to then donate that medicine to low- and middle-income countries.
While the outbreak has remained primarily contained to the Congo, U.S. health officials emphasized the value to public health preparedness of having an approved vaccine.
"Ebola virus disease is a rare but severe and often deadly disease that knows no borders," Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, said in a Dec. 19 statement. "Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur."
The FDA issued a priority review voucher to Merck along with the approval.