Good evening, Mr. Chair.
My name is Dr. Marc Berthiaume, and I am the director of the bureau of medical sciences at Health Canada, health products and food branch.
Thank you for inviting me to appear before the committee today. I appreciate this opportunity to discuss Health Canada's high standards for the vaccine approval process and, in particular, to address questions regarding the approval of the AstraZeneca vaccine for people over 65 years of age.
I want to begin by emphasizing that Health Canada authorizes vaccines only if they meet the department's stringent safety, efficacy and quality requirements.
As with the other vaccines, Health Canada conducted independent and thorough scientific reviews to determine that the benefits outweigh the risks for the AstraZeneca COVID-19 vaccine, which was developed in partnership with Oxford University, as well as the Serum Institute of India's version of the AstraZeneca vaccine, sponsored in Canada by Verity Pharmaceuticals.
Health Canada has rigorously evaluated the data available from clinical trials and real-world evidence, and determined that this vaccine is safe to be administered to adults 18 years of age and older.
We also collaborated with the European Medicines Agency on the review of the AstraZeneca vaccine, as part of its open process. This initiative makes it possible for trusted regulatory authorities outside of the European Union, such as Health Canada, to work together and share information throughout the review process.
All regulatory authorities that have authorized the AstraZeneca vaccine have granted unrestricted adult indications.
Even though limited information from clinical trials is available to calculate its efficacy in people 65 years of age and older, Health Canada's authorization for a broad adult population has taken the available data on immune responses into consideration. There is emerging promising evidence that is beginning to be reported from studies on the real-world use of the vaccine, along with data on the safety profile of the vaccine from millions of people who have received it.
In addition to the encouraging real-world evidence that is already showing benefits with respect to outcomes such as hospitalization, it is important to note that there were no safety issues in this age group. There were no issues in the clinical studies, where about 700 people over the age of 65 were administered the vaccine, nor in the large numbers of seniors who have been vaccinated to date in other countries that have also authorized the AstraZeneca vaccine and are administering it to people over the age of 65.
Specifically, during the first summary of the safety reporting period of January 1-31, 2021, safety data was available for over 3.7 million people who received the vaccine, with no safety issues identified. A safety signal of anaphylaxis has more recently emerged, which is currently being added to the product monograph.
Health Canada is aware of the reports in Europe of adverse events, including fatalities, following immunization with the AstraZeneca vaccine, specifically thromboembolic events such as blood clots. We are monitoring and working closely with national regulators to gather information, including the European Medicines Agency, whose safety committee has initiated an accelerated investigation. At this time, we do not believe this is a new safety issue that will impact the deployment of the vaccine in Canada. These sorts of events demonstrate that our rigorous safety system works well to identify and quickly start to investigate issues.
Health Canada is reassuring Canadians that the benefits of vaccination outweigh the risks. We expect further information from ongoing clinical trials and post-market monitoring in the coming months. If there are additional changes required with regard to safety or efficacy, Health Canada will take the necessary actions.
In the meantime, the department has been transparent regarding the data that was considered, and has reflected the limited data on efficacy for those over the age of 65 in its regulatory document, including the product monograph.
I want to point out that all COVID-19 vaccines were authorized in Canada under an interim order approved in September 2020. This enables us to speed up the review of COVID-19 treatments and vaccines, while maintaining a high level of scientific review.
With this interim order, Health Canada can approve a new vaccine based on available evidence with more agile administrative and application requirements. 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 the data becomes available. The interim order also gives Health Canada the authority to impose terms and conditions to require the manufacturer to continue providing information on the safety, efficacy and quality of the vaccine once marketed.
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 additional assessments of safety information. We'll take swift action if safety concerns are identified.
All Health Canada's regulatory decisions are independent and based solely on scientific data and evidence. Our COVID-19 vaccine review teams are comprised of experienced scientific and regulatory experts, including scientists and physicians with many years of experience in reviewing vaccines. Together, these measures have allowed Health Canada to authorize several clinical trials in Canada for COVID-19 vaccines, as well as for five vaccines: Pfizer-BioNTech, Moderna, AstraZeneca, the AstraZeneca version produced by the Serum Institute in India, and Janssen.
As part of our ongoing commitment to openness and transparency, Health Canada has published detailed information about the authorized COVID-19 vaccines on its COVID-19 vaccines and treatments portal. This information includes Canadian product monographs and regulatory decision summaries that provide a high-level summary of the evidence reviewed to support vaccine authorization.
Health Canada and the Public Health Agency of Canada provide weekly updates on reported adverse events following immunization. Our response to the pandemic is being guided by the latest science and research. We're also continuing to closely monitor the emerging viral variants and to work with manufacturers and international regulators in order to assess the impact of the new variants on vaccine efficacy and provide guidance to manufacturers.
Health Canada, together with the Access Consortium that also includes our regulatory counterparts in the United Kingdom, Australia, Switzerland and Singapore, has developed and published guidelines for the industry regarding our common regulatory approach to authorizing updates to existing vaccines in order to combat new variants.
Canadians can rest assured that the review process for each vaccine has been rigorous and that systems are in place to continue to monitor the safety and efficacy of authorized COVID-19 vaccines. The vaccines play a critical role in Canada's response to the pandemic and fight against COVID-19. The authorization of these additional vaccines, which meet Health Canada's rigorous safety, efficacy and quality standards, provides additional tools to fight this pandemic as quickly as possible.
Thank you.