OTTAWA: Health Canada HAS authorized the second COVID-19 vaccine in Canada, manufactured by Moderna. Moderna is an American biotechnology company based in Cambridge, Massachusetts
Health Canada received Moderna’s submission on October 12, 2020, and after a thorough, independent review of the evidence, it has determined that the Moderna vaccine meets the Department’s stringent safety, efficacy and quality requirements.
Prime Minister Justin Trudeau said:”The first doses of Moderna’s COVID-19 vaccine will arrive in Canada in the coming days – and we’ll roll them out across the country as soon as possible. As for the Pfizer vaccine, we’ll be receiving an additional quarter of a million doses next month. That takes us up to a total of almost 751,000 doses from Pfizer in January.
Between the early doses we’ve already received, and the shipments now scheduled, we’re on track to have at least 1.2 million doses of vaccines from both Pfizer and Moderna delivered by January 31st.”
Wednesday’s authorization is a critical step in ensuring additional COVID-19 vaccines are available to all Canadians in all parts of the country. The different storage and handling requirements of the Moderna COVID-19 vaccine mean that it can be distributed to isolated and remote communities, including the territories.
The Department said it was committed to openness and transparency. As such, Health Canada is publishing a number of documents related to this decision, including a high-level summary of the evidence that we reviewed to support the authorization of the vaccine.
More detailed information will be made available in the coming weeks, including a detailed scientific summary and the full clinical trial data package.
Health Canada and the Public Health Agency of Canada will closely monitor the safety of the vaccine once it is on the market and will not hesitate to take action if any safety concerns are identified.
Safety & Efficacy
The terms and conditions of the Moderna vaccine authorization require the manufacturer to continue providing information to Health Canada on the safety, efficacy and quality of the vaccine to ensure the benefits of the vaccine continue to be demonstrated through market use. To further support the safe use of the Moderna vaccine, the National Advisory Committee on Immunization (NACI) will update its recommendations on the use of COVID-19 vaccines to inform federal, provincial, and territorial immunization programs.
The vaccine is indicated for use in people 18 years of age or older. Moderna is currently conducting additional studies in children from 12 years of age and older, and this indication could be revised in the future to include children if the data from these studies support it. The vaccine was authorized under Health Canada’s Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19.
This process allowed Health Canada to assess information submitted by the manufacturer as it became available during the product development process, while maintaining Canada’s high standards.
Federal Health Minister Patty Hajdu said: “This is great news for all Canadians, but we have
a long road ahead and we must maintain our public health measures.”
TORONTO: Premier Doug Ford issued the following statement following approval of the Moderna COVID-19 vaccine: “This is phenomenal news for Ontarians and Canadians – yet another life-saving COVID-19 vaccine has been approved for safe and effective use in the province and in the country. We are taking another step towards ending this terrible pandemic.
The federal government has allocated approximately 53,000 doses of the Moderna COVID-19 vaccine for Ontario in December 2020, and they will be delivered before the end of the month. These are the first of 40 million doses Canada will be receiving from Moderna. The Moderna vaccine is a real gamechanger as it does not need to be stored at extremely cold temperatures and is more mobile.
This means health staff can administer this vaccine onsite in our long-term care homes, retirement homes, congregate care settings, rural and remote locations, and other places where our most vulnerable populations live. For the first time, we can take the vaccine directly to our priority groups. Phase Two of Ontario’s vaccination program is expected to begin this spring when Ontario receives more of the ordered doses of vaccine from both Pfizer and Moderna, and potentially other vaccines, as they go through clinical trials and approvals.
General Rick Hillier and the COVID-19 Vaccine Distribution Task Force are ready to distribute these vaccines as soon as the province receives them.
As we await the arrival of more vaccines, I continue to ask all Ontarians to remain vigilant and keep following the public health measures, including wearing a mask when required, maintaining physical distancing, and avoiding social gatherings, especially during the holiday season. These measures remain our best and only defence against fighting this virus until the vaccine is more widely available.”