Mr. Speaker, with regard to parts (a) to (j), as part of the standard regulatory process for drugs and vaccines, when a new drug or vaccine is authorized by Health Canada, a drug identification number, DIN, is issued. The product DIN is a unique number that identifies the following product characteristics: manufacturer, product name, active ingredients, strengths of active ingredients, pharmaceutical form, and route of administration. As the circulating strains of the SARS-CoV-2 virus change, companies update their COVID-19 vaccines based on the latest evidence to ensure Canadians have access to vaccines that target the latest strains of the virus. The updates are filed to Health Canada for review and are considered as modifications to the existing drug rather than a new drug. Therefore, a new DIN is not issued for the updated vaccines should they be authorized by Health Canada, but the previous vaccines should be quarantined or removed from sale to ensure that there is no overlap of two different vaccines with the same DIN. The DIN is an important element that is used to track vaccine safety, and it is important to have a discrete vaccine assigned to the DIN to ensure adverse events following vaccination are tagged to the correct product. This is the same approach that is taken for the annual influenza vaccines and is consistent with the approach of our international regulatory partners such as the European Medicines Agency and the Food and Drug Administration.
COVID-19 vaccine targeting the XBB 1.5 variant are no longer available on the Canadian market, as an updated formulation with increased effectiveness has now been approved. The Moderna Spikevax and Pfizer-BioNTech Comirnaty KP.2 COVID-19 mRNA vaccines were authorized by Health Canada on September 17, 2024, and September 24, 2024, respectively and are available to provinces and territories to support 2024-25 immunization activities.
In September 2024, Health Canada authorized two updated mRNA-based COVID-19 vaccines that more closely match circulating strains: Spikevax by Moderna for the KP.2 strain, and Comirnaty by Pfizer for the KP.2 strain. Beyond the mRNA coding for a different strain, the formulations of the updated vaccines remain unchanged. The Pfizer presentation has been expanded to include a single-dose syringe in addition to the multidose vial.
Health Canada cannot comment on the mRNA sequence of the Pfizer vaccine, as this is confidential business information. However, it is noted that the presence of the SV40 promoter enhancer sequence is not the same as the presence of the whole virus itself. 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 biologic and radiopharmaceutical drugs directorate, BRDD, within the health products and food branch of Health Canada is responsible for the review of biologics, including mRNA-based vaccines. The products assigned to each review centre are determined by product indication, product technology, reviewer expertise and workload. Currently, mRNA vaccines are reviewed in the centre for vaccines, clinical trials and biostatistics of the BRDD.
The estimated number of COVID-19 vaccines in federal possession requiring destruction is approximately 670,000 doses of Pfizer. The estimated cost for the destruction of the 670,000 doses is approximately $137,000.