WHO, DRC Advance Ebola Vaccine Trial as Outbreak Surges

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- WHO and DRC authorities are in talks to launch a multi-armed Phase 3 clinical trial of Ebola vaccines targeting the Bundibugyo virus in northeast DRC, with the protocol nearing submission to regulatory and ethics committees in-country.
- Tedros Adhanom Ghebreyesus warned Wednesday that the outbreak is already the second-biggest Ebola epidemic on record, is "moving faster than any previous Ebola outbreak," and is on track to eclipse the 2014-2016 West African crisis.
- As of Aug. 10, the outbreak centered in Ituri province near the Uganda and South Sudan borders had confirmed more than 4,500 cases and more than 2,060 deaths.
- Merck's Ervebo will be the first vaccine pushed into the trial despite targeting Ebola Zaire rather than Bundibugyo, after animal and human studies persuaded WHO's expert panel it may offer cross-protection.
- WHO's Vasee Moorthy said contacts of cases will be individually randomized — an approach he called "more efficient" than the ring vaccination method used in the Guinea Ebola Ça Suffit trial, which established Ervebo's ~84% effectiveness against Ebola Zaire.
- Bundibugyo-specific candidates from the Oxford Vaccine Group/Serum Institute of India and Moderna's mRNA vaccine could join the trial in early autumn if Phase 1 results, expected in September, support their use; IAVI's third candidate is months from Phase 3 readiness.
- WHO officials did not address DRC's separate announcement that it wants to roll out Ervebo for general use outside a trial — a plan backed by Africa CDC but constrained by a roughly 500,000-dose stockpile controlled by the International Coordinating Group on Vaccine Provision.
Why it matters: DRC's push to deploy Ervebo outside a trial clashes with WHO's randomized Phase 3 design, which is the only path to generating efficacy data against Bundibugyo — and the roughly 500,000-dose global stockpile controlled by the International Coordinating Group on Vaccine Provision sits between those competing demands. With more than 2,060 already dead and cases climbing faster than any prior Ebola outbreak, the speed of the trial launch directly determines whether cross-protecting or Bundibugyo-specific vaccines can be matched to the epidemic's trajectory.
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