Health Canada has given biotechnology company Moderna the go-ahead to start a clinical trial for a vaccine designed to combat the Bundibugyo strain of the Ebola virus, which has killed more than 1,650 people in one African country.
The government agency announced on Aug. 4 that it had authorized Moderna’s mRNA vaccine as part of an early stage study, making Canada the second country to authorize a Phase I clinical trial for a Bundibugyo virus vaccine candidate after the UK.
There is currently no licensed vaccine or treatment for the Bundibugyo virus, the variant of Ebola responsible for the ongoing outbreak in the Democratic Republic of the Congo. The outbreak is concentrated in the central African country, but there have also been a small number of deaths in neighbouring Uganda.
Health Canada has confirmed there are no domestic cases.
Massachusetts-based Moderna says the first participants in the early stage study have already been administered the shot, referred to as mRNA-1469.
“Vaccinating the first participants with mRNA-1469 marks an important milestone in advancing a vaccine candidate against Bundibugyo ebolavirus, for which no approved vaccine currently exists,” Macarena CEO Stéphane Bancel said in a press release. “We are grateful to CEPI, Health Canada, the investigators and study participants for their contributions to advance this work.”
The first phase is being conducted at three undisclosed locations in Canada, and will evaluate the safety, tolerability, and immunogenicity of mRNA-1469 among approximately 80 healthy adult participants.
Health Canada said participants in the first trial phase will not be injected with an orthoebolavirus and cannot become sick with Ebola disease. They will be given a dose of the candidate vaccine and researchers will assess whether the participants’ immune system starts making antibodies to the Bundibugyo virus.
The experimental vaccine employs the same mRNA technology that serves as the foundation for Moderna’s COVID-19 vaccine and also expands upon the company’s prior research and development work in filoviruses, the firm said.
The goal of the clinical trial is to evaluate the safety of the candidate vaccine, establish the appropriate dosage range, and identify side effects, Health Canada said.
“Following this, Moderna would be required to conduct additional clinical trial phases before it could seek approval from Health Canada for the vaccine,” the agency said. “Any final submission would need to meet Health Canada’s stringent safety, efficacy and quality standards before the vaccine could be allowed on the Canadian market.”
If the vaccine is approved, Moderna said it will make at least 500,000 doses available to low- and middle-income countries at “access pricing.”
The Bundibugyo strain is responsible for an outbreak in the Democratic Republic of Congo that has grown into the second-largest Ebola outbreak in history, with 3,748 confirmed cases and 1,657 deaths reported as of Aug. 1, according to the U.S. Centers for Disease Control and Prevention.
The World Health Organization and Africa CDC have both declared the current outbreak a public health emergency.
The Public Health Agency of Canada said the overall risk to the general population in Canada remains low.
“If an infected person were to arrive in Canada, transmission is expected to be limited due to established public health measures, enhanced border screening measures and because the virus requires direct contact with body fluids or tissues of infected individuals,” the agency said.
In the meantime, the public health agency said it is “actively monitoring” the outbreak in collaboration with its international partners.
