Gavi welcomes WHO recommendation to include Ervebo vaccine in clinical trials as part of Bundibugyo Virus Disease response

Gavi, the Vaccine Alliance welcomes the news that the WHO Technical Advisory Group on candidate vaccine prioritization (TAG-CVP) for Bundibugyo virus disease (BVD) outbreak response recommends that the existing approved Ebola vaccine – Ervebo (rVSV-ZEBOV) - should be prioritized for inclusion in a Phase 3 trial in the context of the ongoing BVD outbreak. In its recommendation, WHO noted the large amount of safety and immunogenicity data available for Ervebo – which has been used to help control several Ebola Zaire outbreaks over the past decade – which makes it suitable to directly enter into Phase 3 evaluations for Ebola Bundibugyo.

Doses of Ervebo from the global Ebola vaccine stockpile, established and funded by Gavi and managed by the Interagency Coordination Group on Vaccine Provision (ICG), are expected to be made available to support trials. 

Any trial of Ervebo in the context of this BVD outbreak will complement existing efforts to develop a Bundibugyo-specific vaccine. Gavi is supporting this work through a US$40 million investment from its First Response Fund, with the aim to accelerate and scale access to promising Bundibugyo-specific candidates for investigational use in outbreak response and, eventually, WHO pre-qualification.

“This is already the largest Ebola outbreak in DRC’s history, and could well become the largest outbreak ever. And it is occurring in areas where we know, from experience, outbreaks are difficult to control. Given the terrible toll on communities and frontline workers, we are encouraged that the approved Ebola vaccine Ervebo – readily available through our Gavi-funded global stockpile – could help reduce severe illness and deaths, and we are committed to supporting its trial alongside our continuing work on accelerated access to promising Bundibugyo-specific candidates,” Dr Sania Nishtar, CEO of Gavi, the Vaccine Alliance.”ward to renewing this partnership and achieving even greater impact in the years ahead.” 

×