Thank you, Mr. Chair.
I would like to thank the committee members for the opportunity to appear before you today. Joining me is Health Canada's chief medical advisor, Dr. Supriya Sharma, and the acting associate assistant deputy minister of the health products and food branch, Dr. Celia Lourenco.
Health Canada is responsible for regulating health products in Canada, including vaccines. The department evaluates data in support of the safety, quality and efficacy of health products before authorizing them for sale in Canada. We also monitor the safety of health products while they are on the market and take prompt action should safety concerns emerge.
Health Canada acknowledges the extensive effort of the Office of the Auditor General, in collaboration with relevant partners across government, in developing the COVID‑19 vaccines report assessing the procurement, authorization, allocation, distribution and surveillance of COVID‑19 vaccines.
In fulfilling its mandate, Health Canada relies on information sharing with the Canada Public Health Agency in collaboration with the provinces and territories to continuously monitor vaccine safety.
I will focus on the areas of the audit relating to Health Canada’s responsibilities. Specifically, the authorization of COVID‑19 vaccines, surveillance, and data sharing.
The COVID-19 pandemic presented a global threat and public health emergency that required the federal government to act quickly regarding vaccine approval, procurement, distribution and surveillance.
One of Health Canada's top priorities in light of the pandemic was to exercise regulatory agility to support access to vaccines while maintaining rigorous evidence standards that were aligned with those of international regulatory partners.
Health Canada welcomes the results of the audit that found that Health Canada expedited the regulatory review and authorization of the vaccines used to combat COVID-19 while upholding the rigorous standards required for our approval. The expedited authorization process was developed and implemented for COVID-19 vaccines through an interim order and modified the department's usual process in a few key ways.
First, the department created dedicated teams that focused on the review of COVID‑19 vaccines by mobilizing existing internal resources with expertise in vaccines.
Second, Health Canada authorized vaccine manufacturers to submit data on a rolling basis, which allowed us to review data from early in the development of the vaccine while later-stage clinical trials were taking place. The vaccines were only authorized once all the necessary data were reviewed and considered acceptable.
Third, we applied terms and conditions on each vaccine authorization to more closely monitor vaccine safety, quality and effectiveness as they are administered in Canada and globally.
Finally, Health Canada cooperated extensively with our international partners to share information during the review process and reduce duplication.
The audit concluded that the Public Health Agency and Health Canada efficiently provided access to COVID‑19 vaccines, with Health Canada’s expedited authorization process playing a critical role in ensuring that vaccine doses were available to Canadians in a timely manner.
The audit also found that the Public Health Agency and Health Canada shared relevant surveillance data, such as cases of adverse events following immunization, to effectively monitor the safety and effectiveness of COVID-19 vaccines. This allowed both organizations to take immediate action in response to vaccine safety signals resulting from reported adverse events and subsequently communicate them to the Canadian public and to the vaccine manufacturers. In doing so, Health Canada was able to act appropriately and in a timely manner to respond to confirmed vaccine safety signals based on reported adverse events.
However, the audit also highlighted long-standing issues related to data sharing, which affected the Public Health Agency's ability to share detailed case-level safety surveillance data with Health Canada. For example, the audit recommended that more should be done to facilitate the sharing of surveillance data with Health Canada by allowing the department access to the Canadian adverse events following immunization surveillance system, CAEFISS, and by expediting the implementation of the pan-Canadian health data strategy.
Health Canada agrees with the audit's findings. Its recommendations validate the department's efforts to advance a more robust and consistent method of sharing health data.
Health Canada will continue to collaborate with the Public Health Agency and provinces and territories on the pan-Canadian health data strategy, and we support ongoing work with provinces and territories to provide greater access to CAEFISS.
In closing, Health Canada welcomes the Auditor General’s recommendations and is committed to continuous improvement in the timely access to accurate health data to achieve better health outcomes for Canadians.
Thank you again to the committee for inviting me. I will be pleased to answer any questions you may have.