Mr. Speaker, in response to (a), Health Canada, HC, verifies that companies manufacturing vaccines destined for the Canadian market comply with Canada’s high safety and quality requirements, whether the drug is manufactured domestically or abroad. Within Canada, all drug manufacturers are inspected by Health Canada. For foreign manufacturing sites, Health Canada conducts inspections or assesses inspection results from trusted international regulatory partners.
Health Canada is also committed to verifying signals and complaints regarding the safety, efficacy and quality of vaccines. When there is suspected non-compliance, the department takes steps to verify if non-compliance has occurred. Health Canada uses a variety of compliance and enforcement tools to monitor and verify that regulated parties comply with requirements, including on-site visits.
In response to (b), should Health Canada have any concerns surrounding a product, we may request samples from any lot and conduct in-house testing through the lot release program. Health Canada can request products for testing through this program when a product is being reviewed by the department prior to market authorization or at any time during the post-market stage.
The HC lot release program is fully independent of the manufacturer’s testing and is one means used for ensuring the quality of vaccines released onto the Canadian market. Test methods used by the lot release program are validated, laboratory staff are qualified and trained, the laboratories and methods are accredited by the International Organization for Standardization, ISO, and results are reviewed by experienced HC evaluators familiar with the vaccine and test methods. Health Canada does not use third party or contract labs for the lot release of vaccines. All vaccine lot release laboratories in Health Canada currently have sufficient staff required for conducting the required test methods.
In response to (c), the primary objective of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians using the most appropriate level of intervention based on the risk posed to the general public.
When non-compliances are identified, we will take appropriate actions to protect the health and safety of Canadians. This can include requesting recalls, issuing risk communications to alert the public and/or suspending licences. Health Canada has the ability to order a product recall or require a product label change if serious health and safety risks are identified. The department takes compliance and enforcement actions in line with our compliance and enforcement policy, where actions are based on the specific facts of each case and appropriate for the situation.
Where appropriate, the department may conduct investigations, make referrals to law enforcement, and refer cases to the Public Prosecution Services of Canada, PPSC, for potential prosecution. The courts have the sole discretion to impose penalties. While monetary fines and penalties can be levied by the courts under the Food and Drugs Act as a result of prosecutions, health product compliance programs do not have the ability to issue administrative monetary penalties in the event of contraventions.
In response to (d), the Pfizer-BioNTech mRNA vaccine is not considered adulterated. 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. The Pfizer-BioNTech mRNA vaccine currently on the market is consistent with the product/process submitted to Health Canada for authorization. Therefore, no measures under the FDA were taken.
In response to (e), see response to (d).
