The World Health Organization (WHO) today prequalified an Ebola vaccine for the first time, a critical step that will help speed up its licensing, access and roll-out in countries most at risk of Ebola outbreaks. This is the fastest vaccine prequalification process ever conducted by WHO.
“This is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine,” said Dr. Tedros Adhanom Ghebreyesus, WHO Director-General in a press statement. “Five years ago, we had no vaccine and no therapeutics for Ebola. With a prequalified vaccine and experimental therapeutics, Ebola is now preventable and treatable.”
The decision is a step towards greater availability of the vaccine in the future, though WHO said that the licensed doses will only be available from mid-2020.
This announcement comes less than 48 hours after the European Commission decision to grant a conditional marketing authorization for the vaccine, following the recommendation from the European Medicines Agency (EMA).
Due to the urgent public health need for a prequalified Ebola vaccine, WHO accelerated prequalification by reviewing safety and efficacy data as the information became available. Representatives from the prequalification team participated in the EMA evaluation process to address programmatic suitability for at-risk countries in Africa.
“The development, study, and rapid prequalification of this vaccine show what the global community can do when we prioritize the health needs of vulnerable people,” said Dr. Tedros.
WHO is also facilitating licensing of the vaccine for use in countries at risk of Ebola outbreaks, based on the reviews and positive outcome by the EMA.
The current epidemic in DR Congo is the tenth in the country since the first in 1976. It is the second most deadly to date after a 2014-2016 outbreak which cost some 11,000 lives and underscored the urgency to bring a vaccine to market.