WHO recommends Phase III trial for Ebola vaccine against Bundibugyo virus

The World Health Organization (WHO) has recommended advancing an Ebola vaccine, Ervebo, into a Phase III trial to determine its efficacy against the Bundibugyo virus. This move comes as two vaccines specifically designed for the Bundibugyo virus have entered Phase I safety trials. Promising animal studies indicated that Ervebo, already approved for Ebola virus disease, might offer cross-protection against the Bundibugyo virus.

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two vaccines specifically developed against the Bundibugyo virus had entered Phase I safety trials in humans.

WHO Director-General Tedros Ghebreyesus announced the recommendation via X (formerly Twitter), expressing hope to begin the Phase III trial as soon as possible. The trial aims to establish Ervebo's safety and effectiveness in protecting humans against Bundibugyo virus disease, providing crucial data for current and future outbreaks.

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new animal studies had shown promising evidence that Ervebo, an Ebola vaccine, could also provide cross-protection against the virus.

The Bundibugyo virus outbreak in the Democratic Republic of Congo (DRC) has become the second-largest Ebola outbreak recorded. As of Thursday, the DRC reported 4,449 confirmed cases and 2,061 deaths across five provinces. The WHO noted the outbreak is spreading faster than previous ones at similar stages and could potentially exceed the 2014–2016 West African outbreak.

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the findings prompted WHO to recommend Ervebo for inclusion in a Phase III trial, which the organisation hopes to begin as soon as possible.

Currently, there is no licensed vaccine specifically approved for preventing Bundibugyo virus disease, although Ervebo is the only licensed and WHO-prequalified vaccine for Ebola virus disease. Previous outbreaks of the Bundibugyo virus have had case fatality rates ranging from 30% to 50%. The WHO also reported progress in treatment research, with a WHO-sponsored trial reaching 100 patients.

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the outbreak was spreading faster than any previous Ebola outbreak at the same stage and could surpass the 2014–2016 West African outbreak