Since the start of the pandemic, Health Canada has worked closely with other departments and the Vaccine Task Force to develop and implement Canada's vaccine strategy. Early on, we recognized the need to facilitate clinical trials of drugs for COVID-19, given that no treatments or vaccines were available for this new virus.
In May 2020, Canada’s Minister of Health approved an interim order to facilitate clinical trials for COVID-19 products. Among its benefits, the Interim Order reduces the administrative burden for sponsors without compromising the safety of participants, and makes it easier to set up trials across Canada.
In September 2020, the Minister of Health introduced another interim order to expedite the review of treatments and vaccines for COVID-19, while maintaining a high level of scientific scrutiny.
This interim order allows Health Canada to approve a new vaccine based on available evidence with more agile administrative and application requirements and to apply terms and conditions to require the manufacturer to continue providing information on the safety, efficacy and quality of the vaccine once marketed; and permits the Public Health Agency of Canada to arrange for the importation of promising COVID-19 drugs into Canadian facilities prior to approval in Canada.
The interim order also allows for rolling reviews, which lets a vaccine manufacturer submit its request for authorization before it has completed all the clinical trials. This means that it can submit required data as they become available.
Additionally, we have a strong post-market safety surveillance system to monitor the safety of COVID-19 vaccines. Once a vaccine is on the market, Health Canada and the Public Health Agency of Canada monitor for any adverse events after immunization in collaboration with the provinces and territories and the manufacturer. The interim order provides the authority to impose terms and conditions on any authorization at any time, such as conducting additional assessments of safety information.
All of Health Canada's regulatory decisions are independent and based solely on science and evidence.
So far, 10 submissions have been received under the interim order—including four treatments and six vaccines. Two vaccines and one treatment have been authorized, while the others remain under review.
Another key step that we have taken to ensure timely and thorough approvals is hiring additional scientists and establishing dedicated review teams for COVID-19 vaccines, in order to ensure consistency in reviews. These review teams, comprised of experienced regulatory and scientific experts, focus solely on COVID-19 work, and have been working around the clock on the scientific reviews of submissions.
Health Canada reviewers are scientists and physicians with many years of experience reviewing vaccines, and with expertise in different domains including, but not limited to, clinical medicine, toxicology and pharmacology, biochemistry, virology, immunology, microbiology, and other scientific disciplines relevant to the development, testing, manufacture and quality control of vaccines.
Furthermore, as soon as there was information that vaccines were going to be developed, our department worked closely with other international regulators and the World Health Organization to collaborate on the regulatory requirements for COVID-19 vaccines and to make the regulatory processes as efficient as possible.
These partnerships allow us to share information, support scientific collaboration and align regulatory approaches and requirements for vaccines, while still making independent decisions for Canadians.
Together, these measures have allowed Health Canada to authorize several clinical trials in Canada for COVID-19 vaccines, as well as the two vaccines, Pfizer-BioNTech and Moderna, that are already being administered to Canadians.
Our response to the pandemic is being guided by the latest science and research. We also continue to monitor the emerging viral variants closely, and work with manufacturers and international regulators to assess the impact of the new variants on vaccine efficacy and provide guidance to manufacturers.
As part of our commitment to openness and transparency, Health Canada has published detailed information about the authorized COVID-19 vaccines on the department's new COVID-19 vaccines and treatments portal. Health Canada and the Public Health Agency of Canada also provide weekly updates on reported adverse events following immunization.
Canadians can feel confident that the review process for vaccines is rigorous and that we have a strong monitoring system in place.
Once again, thank you for this opportunity to speak with the committee today. I'd be happy to answer any follow-up questions you may have regarding Health Canada's vaccine approvals process.
Thank you.