Mr. Speaker, Health Canada initially authorized the Moderna and Pfizer-BioNTech COVID-19 mRNA vaccine in December 2020 and subsequently has authorized updated versions, including the most recent vaccine targeting the XBB Omicron subvariant in late 2023: https://covid-vaccine.canada.ca. Each assessment included a determination that the vaccine met the department's stringent regulatory, safety, efficacy and quality requirements for use in Canada.

In response to part (a)(i) of the question, as a regulator, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself and about the manufacturing process. There are strict limits and controls to ensure the safety and effectiveness of the vaccine. The department authorizes a product only once the data has been reviewed and demonstrates that the product’s benefits outweigh its risks.

Prior to Health Canada authorization, the mRNA vaccines were tested in preclinical safety studies for general and reproductive toxicity, and no safety signals related to frame shifting were reported.

After authorization, Health Canada continues to monitor the safety of COVID-19 vaccines through surveillance and risk minimization measures, including requiring manufacturers to regularly submit safety reports and reports of adverse events following immunization, or AEFIs, and regularly assessing whether there is any new safety information that may affect the benefit-risk profile of the product. Should a safety issue be confirmed, Health Canada will take appropriate action, which may include communicating the risk to Canadians or changing the recommended use of the vaccine.

In response to part (a)(ii) of the question, as a regulator, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself and about the manufacturing process. There are strict limits and controls to ensure the safety and effectiveness of the vaccine. The department authorizes a product only once the data has been reviewed and demonstrates that the product’s benefits outweigh its risks.

The limit for residual DNA in biological drugs required by Health Canada for approval is not more than 10 ng/human dose. This is in line with the World Health Organization’s recommendation concerning residual DNA in biological drugs and is consistent with the quality limits of other international regulators.

After authorization, Health Canada continues to monitor the safety of COVID-19 vaccines through surveillance and risk minimization measures, including requiring manufacturers to regularly submit safety reports and reports of AEFIs, and regularly assessing whether there is any new safety information that may affect the benefit-risk profile of the product. Should a safety issue be confirmed, Health Canada will take appropriate action, which may include communicating the risk to Canadians or changing the recommended use of the vaccine.

In response to part (a)(iii), please see the responses to parts (a)(i) and (a)(ii).

In response to parts (a)(iv) and (v), please see the response to part (a)(i).

In response to part (a)(vi), please see the responses to parts (a)(i) and (a)(ii).

In response to part (a)(vii) of the question, as a regulator, Health Canada sets quality standards and requirements for manufacturers to follow, including providing comprehensive and detailed information about the vaccine itself and about the manufacturing process. There are strict limits and controls to ensure the safety and effectiveness of the vaccine. The department authorizes a product only once the data has been reviewed and demonstrates that the product’s benefits outweigh its risks.

The SV40 promoter/enhancer sequence was found to be a residual DNA fragment in the Pfizer-BioNTech COVID 19 vaccine. The fragment is inactive, has no functional role and was measured to be consistently below the limit required by Health Canada and other international regulators. Health Canada continues to monitor the COVID 19 vaccines to ensure that they continue to meet the highest standards for safety, effectiveness and quality, and that their benefits continue to outweigh any potential risks.

After authorization, Health Canada continues to monitor the safety of COVID-19 vaccines through surveillance and risk minimization measures, including requiring manufacturers to regularly submit safety reports and reports of AEFIs and regularly assessing whether there is any new safety information that may affect the benefit-risk profile of the product. Should a safety issue be confirmed, Health Canada will take appropriate action, which may include communicating the risk to Canadians or changing the recommended use of the vaccine.

For the response to part (a)(viii), please see the responses to parts (a)(i) and (a)(ii).

For the response to parts (b) to (e) of the question, please see the response to part (a)(i).

In response to part (f) of the question, the limit for residual DNA in biological drugs required by Health Canada for approval is consistent with the WHO recommended limit of not more than 10 ng/human dose. There are no proposed changes to this limit for the mRNA vaccines.

Yasir Naqvi

$503,232.00