Market authorisation, prequalification granted for Ebola vaccine

Less than 48 hours after the European Commission announced its decision to grant a conditional marketing authorisation for the recently developed Ebola vaccine, the World Health Organization (WHO) has prequalified the vaccine for the first time — a critical step that will help speed up its licensing, access and rollout in countries most at risk of Ebola outbreaks.

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 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 European Commission’s decision to grant marketing authorisation for the vaccine follows last month’s recommendation from the European Medicines Agency (EMA), which has assessed the benefits and risks of the vaccine. It also follows the recent announcement of a clinical trial for a second Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) that is now underway in the Democratic Republic of Congo, with the support of the EU’s Horizon 2020 research and innovation program.

Prequalification means that the vaccine meets WHO standards for quality, safety and efficacy. Due to the urgent public health need for an Ebola vaccine, WHO accelerated prequalification by reviewing safety and efficacy data as the information became available, resulting in the fastest vaccine prequalification process ever conducted by the organisation. United Nations agencies and Gavi, the Vaccine Alliance can procure the vaccine for at-risk countries based on this WHO recommendation.

“This is a historic step towards ensuring the people who most need it are able to access this life-saving vaccine,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus. “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.”

WHO is now facilitating licensing of the vaccine for use in countries at risk of Ebola outbreaks, based on the reviews and positive response of 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. Licensed doses should be available from mid-2020.

Image credit: ©stock.adobe.com/au/Riccardo Niels Mayer

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