Ebola vaccine attains prequalification

19 November 2019

Article: 53/4605

On 12 November 2019, the World Health Organization (WHO) prequalified the firstĀ  Ebola vaccine, a critical step that will help speed up its licensing, access and roll-out in the countries most at risk of Ebola outbreaks.

Prequalification means that the vaccine meets WHO standards for quality, safety and efficacy. United Nations agencies and Gavi, the Vaccine Alliance, can procure the vaccine for at-risk countries based on this WHO recommendation.

The injectable Ebola vaccine, Ervebo, is manufactured by Merck (known as MSD outside the US and Canada). It has been shown to be effective in protecting people from the Ebola Zaire virus and is recommended by the WHO Strategic Advisory Group of Experts (SAGE) for vaccines as part of a broader set of Ebola response tools.
The decision is a step towards greater availability of the vaccine in the future, though licensed doses will only be available around mid-2020.

The announcement came 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).

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. WHO, with the support of EMA, has worked closely with many African regulators who have indicated they will quickly license the vaccine following the WHO recommendation.

Source: WHO, 12 November 2019