Moderna Advances Investigational Bundibugyo Ebolavirus Vaccine Toward Phase 2/3 Study
Key Highlights
- ➤mRNA-1469 recommended for Phase 2/3 efficacy study in Democratic Republic of the Congo
- ➤Phase 1 single dose generated robust BDBV-specific binding antibody responses
- ➤CEPI committed up to US$58.5 million for mRNA-1469 development and trial doses
- ➤Tumaini study requires regulatory approval before evaluating mRNA-1469 in outbreak response
Expert Statements
Stéphane Bancel, Chief Executive Officer of Moderna
“The ability to rapidly develop and advance vaccine candidates against emerging infectious diseases is an important part of the promise of mRNA technology.”
Stéphane Bancel, Chief Executive Officer of Moderna
“With encouraging early clinical data, we now have an opportunity to evaluate whether our investigational vaccine can help protect people against Bundibugyo virus disease.”
Stéphane Bancel, Chief Executive Officer of Moderna
“We are grateful to CEPI, the DRC authorities and our global health partners and clinical trial participants for their collaboration in advancing this important work.”
Dr. Richard Hatchett, CEO of CEPI
“Safe and effective vaccines are urgently needed to help bring the devastating outbreak in the DRC under control.”
Dr. Richard Hatchett, CEO of CEPI
“Our longstanding partnership with Moderna and the company's dedication to meeting this challenge enabled the vaccine candidate to move rapidly into clinical trials, and the recommendation from WHO's technical advisory group to include it in the Tumaini study is an important milestone.”
Dr. Richard Hatchett, CEO of CEPI
“It brings us a step closer to finding out, as quickly as possible, whether BDBV-specific vaccines can protect people against this disease and, if they can, getting them to the communities that need them most.”
CAMBRIDGE, MA / ACCESS Newswire / November 4, 2026 / Moderna, Inc. (NASDAQ:MRNA) today announced that mRNA-1469, the Company's investigational mRNA vaccine candidate against Bundibugyo ebolavirus (BDBV), has been recommended to advance into a Phase 2/3 efficacy study in the Democratic Republic of the Congo (DRC), supported by encouraging preclinical and Phase 1 clinical data.
The recommendation follows an October 22 review of available evidence by the World Health Organization's Technical Advisory Group on Candidate Vaccine Prioritization (TAG-CVP). Subject to regulatory approval, mRNA-1469 will be evaluated in the Phase 2/3 Tumaini study, which is being conducted as part of the DRC government's response to the Bundibugyo virus disease outbreak.
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