In a landmark decision on 11 November, the European Commission granted a marketing authorisation to the company Merck Sharp & Dohme B.V. for the Ervebo vaccine against Ebola.
Vytenis Andriukaitis, Commissioner in charge of Health and Food Safety, said: “Finding a vaccine as soon as possible against this terrible virus has been a priority for the international community ever since Ebola hit West Africa five years ago. Today’s decision is therefore a major step forward in saving lives in Africa and beyond.”
The vaccine was initially developed by researchers at the Public Health Agency of Canada’s National Microbiology Laboratory, which licensed it to NewLink Genetics Corporation. It was during the West African outbreak in 2014 when Merck obtained the license and developed it further. “It is a historic milestone and a testament to the power of science, innovation and public-private partnership”, commented Merck CEO Kenneth Frazier.
The vaccine, that protects against one of four species of Ebola known to infect humans, the so-called Zaire ebolavirus species, is now being used in the ongoing outbreak in the Democratic Republic of Congo (DRC), based on specific medical protocols. Preliminary vaccine data from the current DRC outbreak demonstrated that Ervebo is 97.5% effective at preventing the disease, which translates into having protected well over 90,000 people during the outbreak.
The Union’s commitment to the fight against the deadly virus was expressed by Christos Stylianides, Commissioner for Humanitarian Aid and Crisis Management and EU Ebola Coordinator, who stated: “The EU is supporting international efforts to combat Ebola on all fronts, from vaccine development to delivering humanitarian aid on the ground. We will continue assisting the fight to tackle epidemic for as long as it takes.”
Less than 48 hours after the Commission’s authorisation, the World Health Organization announced that it has pre-qualified Ervebo, signaling to member countries that the vaccine meets WHO standards for safety, quality, and effectiveness.