The World Health Organization has prequalified the injectable Ebola vaccine Ervebo in a move that will speed up its licensing, access, and roll-out in countries most at risk of Ebola virus outbreaks.
This is the fastest vaccine prequalification process ever conducted by WHO and means that the vaccine has met WHO standards for quality, safety, and efficacy. Ervebo can now be procured by United Nations agencies and Gavi, the vaccine alliance, for countries at risk.
WHO’s approval on 12 November came just a day after the European Commission granted a conditional marketing authorisation for the vaccine, after its own fast tracked review. The commission’s legal approval came after the European Medicines Agency had assessed the benefits and risks of the vaccine.
WHO and the European Medicines Agency are also working with many African regulators, which have indicated that they will quickly license the vaccine after WHO’s recommendation.
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BMJ 2019; 367 doi: https://doi.org/10.1136/bmj.l6505 (Published 13 November 2019)Cite this as: BMJ 2019;367:l6505