Health Canada has granted authorization for Moderna to embark on a clinical trial for a new mRNA vaccine specifically designed to target the Bundibugyo strain of Ebola, a virus linked to the largest outbreak recorded in the Democratic Republic of Congo. Currently, there is no available vaccine or treatment for this strain of Ebola, which has resulted in over 1,700 fatalities in Congo.
Although Ebola has never been detected in Canada, the country is set to be the first participant in Moderna’s global trial that aims to develop a vaccine. The trial is focused on healthy adults, who will not be exposed to the virus during the testing process.
A spokesperson for Moderna announced that the first volunteer received the vaccine on Monday in Truro, Nova Scotia. The company plans to enroll a total of 80 participants from Truro, Halifax, and Toronto. This Phase 1 trial will assess the vaccine's safety, establish the appropriate dosage, monitor any side effects, and evaluate the antibody response generated by the vaccine.
Health Canada confirmed in a release issued on a Tuesday that the clinical trial was authorized on July 30. In addition, the United Kingdom has initiated its own clinical trial for a Bundibugyo virus vaccine developed by the University of Oxford.
According to Health Canada, Moderna will be required to conduct Phase 2 and Phase 3 clinical trials to determine the effectiveness of the vaccine before seeking authorization for broader use in the population. The department emphasized that any final submission for approval would have to meet stringent safety, efficacy, and quality standards set by Health Canada before the vaccine can be made available to the Canadian market.
Ebola is transmitted through unprotected contact with the bodily fluids of individuals infected with the virus or who have died from it. Classified as a filovirus, Ebola can lead to severe hemorrhagic fever, which is often fatal.
Hamilton Bennett, Moderna's executive director of global health security and R&D partnerships, noted that Canada was selected for the initial clinical trial due to the company's extensive experience with early-phase trials in the country, the robust regulatory oversight by Health Canada, and Canada's historical contributions to research on filoviruses.
Bennett remarked, "Canadian researchers and participants are contributing an important first step in a broader international effort to develop a vaccine against a form of Ebola for which no approved protection is currently available." This sentiment reflects the urgency and importance of the trial as the Bundibugyo strain of Ebola was first acknowledged as an outbreak on May 15, and it has since spread within Congo and to neighboring Uganda. The World Health Organization has classified the situation as a public health emergency of international concern.
