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reuters+1reutersaccessnewswireModerna announced Tuesday that it has begun dosing volunteers in the first human trial of mRNA-1469, an experimental vaccine targeting the Bundibugyo strain of Ebola virus — a pathogen with no approved vaccine that is fueling the second-largest Ebola outbreak in history.reuters+1
The Phase 1 trial, authorized by Health Canada, is enrolling about 80 healthy adults across three sites in Canada to evaluate the shot's safety, tolerability, and immune response. The vaccine uses the same mRNA technology behind Moderna's COVID-19 vaccine.accessnewswire+2
The Bundibugyo strain is driving an outbreak in the Democratic Republic of Congo that has produced 3,748 confirmed cases and 1,657 confirmed deaths as of August 1, according to U.S. Centers for Disease Control and Prevention data. CEPI chief executive Richard Hatchett said cases are increasing faster than during the 2014–2016 West Africa epidemic, which remains the largest Ebola outbreak on record.theglobeandmail+2
Both the World Health Organization and Africa CDC have declared the outbreak a public health emergency. Canada is now the second country to launch a Phase 1 trial for a Bundibugyo vaccine candidate, after the United Kingdom, where the University of Oxford began testing a ChAdOx1-based vaccine in July.reuters+2
The trial is part of an expanded partnership with the Coalition for Epidemic Preparedness Innovations, which has committed up to $50 million to support preclinical testing, the Phase 1 study, and scaled manufacturing of additional clinical doses to allow rapid progression to later-stage trials.accessnewswire+1
"Getting Moderna's vaccine candidate into a Phase 1 trial this rapidly is a major step forward in the fight against this deadly outbreak," Hatchett said. "Every day matters, and every vaccine candidate in clinical trials gives us another shot at getting a safe, effective vaccine to the people who need it as swiftly as possible."accessnewswire
Moderna CEO Stéphane Bancel called the first vaccinations "an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists." If eventually licensed, Moderna has committed to making at least 500,000 doses available to low- and middle-income countries at access pricing under its agreement with CEPI.reuters+1