Moderna Begins First Human Trial of Vaccine Against Bundibugyo Ebola Strain Linked to Congo Outbreak

Moderna Inc. has initiated its first human clinical trial in Canada for mRNA-1469, an experimental vaccine targeting the Bundibugyo ebolavirus strain. Backed by up to US$50 million from the Coalition for Epidemic Preparedness Innovations (CEPI), the Phase 1 trial will evaluate safety in 80 healthy adults. The active outbreak in the Democratic Republic of Congo has caused over 1,400 deaths, and no approved vaccine currently exists for this specific strain. If licensed, Moderna has committed to supplying at least 500,000 doses to low- and middle-income nations under access pricing.

mRNA-1469 Phase 1 trial

• ▪The Phase 1 clinical trial of mRNA-1469 is being conducted at three sites in Canada and expects to enroll approximately 80 healthy adult participants.
• ▪The first participant in the mRNA-1469 clinical trial received the vaccine dose on August 3, 2026, in Truro, Nova Scotia.
• ▪Moderna Inc. has initiated a Phase 1 clinical trial in Canada for mRNA-1469, an investigational mRNA vaccine targeting the Bundibugyo ebolavirus.

Bundibugyo ebolavirus outbreak severity

• ▪There are currently no licensed vaccines or therapeutic treatments approved specifically to protect against the Bundibugyo ebolavirus strain.
• ▪The World Health Organization and Africa CDC declared the active Bundibugyo ebolavirus outbreak a public health emergency.
• ▪The Bundibugyo ebolavirus outbreak in the Democratic Republic of the Congo has caused over 3,000 confirmed cases and more than 1,400 deaths.

CEPI funding commitment

• ▪The Coalition for Epidemic Preparedness Innovations is accelerating vaccine development as the Bundibugyo ebolavirus outbreak has spread to a fifth Congolese province.
• ▪The Coalition for Epidemic Preparedness Innovations committed up to US$50 million to support preclinical testing and the Phase 1 trial of mRNA-1469.

Manufacturing scale-up strategy

• ▪The parallel manufacturing strategy is designed to enable rapid progression to Phase 2 and Phase 3 clinical trials if early safety data are favorable.
• ▪Moderna Inc. and the Coalition for Epidemic Preparedness Innovations are funding scaled manufacturing of additional clinical doses in parallel with early development.

Low-income country dose access

• ▪Moderna Inc. committed to making at least 500,000 doses of the Bundibugyo ebolavirus vaccine available to low- and middle-income countries under access pricing if licensed.
• ▪The Africa Centres for Disease Control and Prevention plans to propose using Merck & Co.'s Ervebo vaccine to protect frontline health workers in the outbreak.