Mark Holland

[Questions on the Order Paper, January 29th, 2024]

Mr. Speaker, with regard to part (i), non-clinical biodistribution studies in animals were submitted to Health Canada for regulatory evaluation in the original COVID-19 vaccine submissions, with the following exceptions: Covishield vaccine, for which information was cross-referenced to AstraZeneca’s COVID-19 vaccine given that they are both based on the same viral vector technology; and Covifenz, which uses an adjuvant already approved for influenza vaccines and cross-referenced biodistribution studies that were conducted with the influenza vaccine.

Details of these studies are included in the Summary Basis of Decisions, SBDs. The SBDs can be accessed through this link: COVID-19 vaccines and treatments portal (canada.ca)

With regard to part (ii), non-clinical pharmacokinetic studies that were provided evaluated the biodistribution of the lipid nanoparticle, LNP, formulated with a model mRNA. These studies also evaluated the metabolism and excretion of the novel lipid excipients.

The biodistribution data identified no cause for concern as the spike protein is expressed transiently. For Comirnaty, for example, it peaks at six hours post-injection with signals at the injection site and the liver, then declines over time. Less than 1% of signal was detected in other tissues and it becomes undetectable within 24 hours.

The results of the non-clinical studies as well as the potential risks to humans have been included in the specific product monographs: Spikevax PM, Comirnaty PM and Vaxzevria PM. In addition, specific non-clinical information regarding biodistribution data can be found in the Summary Basis of Decision of Spikevax SBD, Comirnaty SBD and Vaxzevria SBD.

With regard to parts (iii) and (iv), please see the response to part (ii).

With regard to part (v), please see the response to part (ii). All toxicity and biodistribution studies were conducted in line with international standards of WHO Guideline: Non-clinical evaluation of vaccines.

With regard to part (vi), repeat-dose toxicity studies were conducted in accordance with international guidelines of WHO Guideline: Non-clinical evaluation of vaccines.

With regard to part (vii), metabolism studies demonstrated that components of the LNP are slowly metabolized and excreted via the fecal route, and evidence of urinary excretion for some of the lipids. Studies have shown that intravenous and intramuscular injection of mRNA-encoded spike protein is only expressed transiently and at the injection site and the liver, then declines over time. Vaccine produced spike protein is rapidly broken down and does not persist in the body. Many studies have demonstrated that the mRNA remains in the cytoplasm of cells and does not come in contact with human DNA, which resides in the nucleus.

The potential toxic effects of vaccine present in milk are evaluated in reproductive and developmental toxicity studies. No vaccine-related maternal toxicity or overt adverse effects on pre- and post-natal development were observed.

Evidence about the safety and effectiveness of COVID-19 vaccination during pregnancy has been growing from real-world use. The data show that mRNA COVID-19 vaccines are safe for people who are pregnant or breastfeeding. No safety concerns were identified in a study of more than 35,000 pregnant people who received an mRNA COVID-19 vaccine within 30 days of conception. More information about COVID-19 Vaccination and pregnancy is available here: https://bit.ly/3E5bytJ.

With regard to parts (viii) and (ix), please see the response to part (vii).

With regard to part (x), Health Canada is responsible for the regulatory authorization of vaccines, which encompasses the review and assessment of various studies, including biodistribution studies, to ensure the safety and efficacy of vaccines. The National Advisory Committee on Immunization, NACI, primarily focuses on analyzing data from human clinical trials to provide vaccine safety recommendations. NACI's role is not directly involved in the regulatory authorization process or in the initial review of biodistribution studies. The question regarding the timing and manner of informing the Canadian public and medical community about the biodistribution of COVID-19 vaccine components is outside the scope of NACI's mandate, as NACI focuses on analyzing clinical trial data for vaccine safety recommendations rather than regulatory communications.

[Questions on the Order Paper, January 29th, 2024]

Mr. Speaker, in December 2011, the Government of Canada announced that the Canada health transfer, or CHT, would continue to grow at 6% annually from 2014-15 to 2016-17, and beginning in 2017-18, the CHT would grow in line with a three-year moving average of nominal gross domestic product, or GDP, growth with funding guaranteed to increase by at least 3% per year.

The December 2011 announcement effectively extended the 6% CHT escalator for three additional years beyond the legislated time frame set out in the September 2004 10-year plan to strengthen health care, which was to end in 2013-14. This resulted in the CHT continuing to grow at 6% annually for 2014-15 to 2016-17, thereby providing provinces and territories with additional CHT growth in those years. Since then, the CHT has grown at an average annual rate of 4.9% under the current GDP-based escalator, which provided provinces and territories with ongoing and predictable funding for health care. In addition, budget 2017 included a targeted investment of $11 billion in federal funding over 10 years to improve home and community care and mental health and addiction services.

Looking forward, the government's working together to improve health care for Canadians plan, first announced in February 2023, includes $25 billion through new tailored bilateral agreements and billions more through top-ups to the CHT and other funding. In total, the Government of Canada is investing over $200 billion over the next 10 years to support provinces and territories to strengthen Canada’s universal public health care system.

Historical data for the Canada health transfer and other major federal transfers to provinces and territories can be found at the following link: https://open.canada.ca/data/en/dataset/4eee1558-45b7-4484-9336-e692897d393f

[Questions on the Order Paper, January 29th, 2024]

Mr. Speaker, with regard to (a) and (b), the incidence rate of tuberculosis, or TB, in Canada is broken down by province and by territory and by Indigenous group, namely First Nations, Inuit and Métis, for the 2008-2018 time period and can be found at https://opencanada.blob.core.windows.net/opengovprod/resources/1ff8f1b6-02a8-425a-bd0b-af9495d2e53c/tb-in-canada_2008-2018_eng_march24-2022.pdf?sr=b&sp=r&sig=D6d5ljkzoXi4CwVF9%2BMAAxZrPYJN2tG8/yQBAvKkhzA%3D&sv=2019-07-07&se=2024-01-30T02%3A27%3A38Z.

Surveillance data for the 2012-2021 reporting period will be published on the Government of Canada website in winter 2024 in a new report entitled “Tuberculosis in Canada: 2012-2021 Expanded report.” The report will include updated data broken down by province and by territory, as well as descriptive statistics on a wide range of variables related to TB. A summary of TB data for the 2012 to 2021 time period was recently published and can be found at https://www.canada.ca/en/public-health/services/publications/diseases-conditions/tuberculosis-surveillance-canada-summary-2012-2021.html. With regard to the incidence rate of TB in 2021, the data showed 135.1 cases per 100,000 among Inuit people, 16.1 cases per 100,000 among First Nations people and 2.1 per 100,000 among Métis people.

Additionally, an infographic with surveillance highlights entitled “Tuberculosis in Canada: Infographic (2021),” is available at https://www.canada.ca/en/public-health/services/publications/diseases-conditions/tuberculosis-canada-2021-infographic.html. It is expected that an infographic presenting 2022 data will be released by March 2024.

With regard to (c), the Public Health Agency of Canada, or PHAC, Health Canada, and other federal departments such as Indigenous Services Canada and Immigration, Refugees and Citizenship Canada meet regularly to discuss national TB surveillance trends and interventions to support TB elimination such as support for outbreaks, access to TB medications, capacity building, and other activities. These departments and other partners, such as the provinces, territories, Indigenous groups and TB experts, use national TB surveillance reports to measure Canada’s progress towards TB elimination targets and commitments which in turn help to inform TB policy and program decision making, research initiatives and innovation related to TB. TB surveillance reports are also used by provincial and territorial partners for benchmarking and to inform decision-making.

With regard to (d), demographic data collected through Canada’s TB surveillance system originate from the provinces and territories. The data includes province or territory of residence, population group, namely the country of birth, immigration status, the year of arrival in Canada and Indigenous groups, age and sex. A complete list of variables can be found on our case report form available at https://www.canada.ca/content/dam/phac-aspc/documents/services/diseases/tuberculosis/active-tuberculosis-reporting-form-eng.pdf.

The national surveillance system consists of TB related data submitted from provincial and territorial public health departments but does not include specific information on health care.

With regard to (e), the TB surveillance program at PHAC has a total funding of $1,222,030 for fiscal year 2023-2024, which includes employee salaries, program operations and maintenance. Furthermore, the dissemination of the infographic and surveillance report have an estimated cost of $6,500.

With regard to (f), active TB cases are reported to the National Tuberculosis Surveillance system on an annual basis in the summer months following the calendar year in which they were diagnosed. A national report is then produced usually in the fall and published in the winter. The time period between when data are submitted to PHAC and published include requirements for cleaning data, verifying quality, analyzing, reporting, and publishing.

With regard to (g), guided by recommendations from an Expert Advisory Group, there was significant collaboration between the federal, provincial, and territorial governments towards a pan-Canadian health data strategy, focused on common priorities such as modernizing and aligning health data standards, policies and governance, and building public trust. This work set the stage for enhanced collaboration across the country, under the Government of Canada’s “Working Together to Improve Health Care for Canadians” Plan, announced in February 2023, and a Federal, Provincial, and Territorial Joint Action Plan on Health Data and Digital Health, which was endorsed by Ministers of Health on October 12, 2023. More information on the “Working Together to Improve Health Care for Canadians” Plan is available at https://www.canada.ca/en/health-canada/news/2023/02/working-together-to-improve-health-care-for-canadians.html.

The Pan-Canadian Health Data Strategy, or PCHDS, led to the release of a final report in May 2022 led by an Expert Advisory Group which includes recommendations for health data partners from all jurisdictions, namely federal, provincial and territorial, which can be found at https://www.canada.ca/content/dam/phac-aspc/documents/corporate/mandate/about-agency/external-advisory-bodies/list/pan-canadian-health-data-strategy-reports-summaries/expert-advisory-group-report-03-toward-world-class-health-data-system/expert-advisory-group-report-03-toward-world-class-health-data-system.pdf.

Some of these recommendations align with the work being undertaken by PHAC’s TB surveillance program. The program works collaboratively with federal, provincial and territorial surveillance stakeholders to collect common indicators for TB. In addition, to better understand data needs, gaps and expectations, bilateral discussions with provincial and territorial TB partners took place in the summer and fall 2023. This aligns with recommendation #5 from the PCHDS: Establish meaningful and ongoing engagement with the public and stakeholders to understand their health data needs and expectations.

Furthermore, the PHAC TB surveillance program is exploring the development of a new surveillance infrastructure to modernize the storage, management and analysis of data. This is expected to improve timeliness and data quality and aligns with recommendation #9: Establish common integrated health data standards and data architecture and drive and monitor their roll out.

[Questions on the Order Paper, January 29th, 2024]

Mr. Speaker,the precise origin of COVID-19 remains unknown. The first report of an unknown pneumonia outbreak in China, later called COVID-19, was detected by the Global Public Health Intelligence Network or GPHIN on December 30, 2019. The information was then distributed to Canadian public health practitioners on December 31, 2019, via the GPHIN Daily Report. The Public Health Agency of Canada orPHAC actively monitored the situation and initiated regular and ongoing communications with federal, provincial and territorial partners.

The Government of Canada is supportive of all efforts that will contribute to a clear understanding of the origins of the virus. Canada continues to work with international partners to better understand the origins of COVID-19.

[Questions on the Order Paper, January 29th, 2024]

Mr. Speaker, with regard to part (a), Pfizer’s submission provided information that process one was used for clinical trials and process two was used for commercial scale-ups. The residual DNA limit is the same for both processes and is in line with the recommendation from the World Health Organization. The comparability of the vaccine produced by these two processes was demonstrated based on their biological, chemical and physical characteristics.

With regard to part (b), Health Canada was aware of the presence of residual plasmid DNA because in the manufacture of any vaccine, residual elements are part of the standard manufacturing process and may remain. There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine.

The limit for residual DNA in biologic drugs required by Health Canada for approval is not more than 10 nanograms per 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.

It is important to assess the results using the authorized validated assays performed by the vaccine manufacturers to ensure that the quality of commercial vaccine lots is comparable to that of lots shown to be safe and efficacious in clinical studies.

With regard to part (c), refer to part (b).

With regard to part (d), Health Canada initially authorized the 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 September 2023. Each assessment included a determination that the vaccine met the department's stringent regulatory safety, efficacy and quality requirements for use in Canada.

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. In the manufacture of any vaccine, residual elements that are part of the standard manufacturing process may remain. There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine.

The simian virus 40, 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.

With regard to parts (e) and (f), in the case of the Pfizer-BioNTech COVID-19 vaccine, the full DNA sequence of the Pfizer plasmid was provided at the time of initial filing. 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. Monitoring of the residual DNA fragments is conducted by the manufacturers using methods that have been reviewed and validated by Health Canada as appropriate for its purposes. All Pfizer-BioNTech’s COVID 19 vaccine commercial batches released in Canada complied with the requirements approved by Health Canada, including the residual DNA.

With regard to part (g), refer to part (f).

With regard to part (h), as a regulator of vaccines, 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. In the manufacture of any vaccine, residual elements that are part of the standard manufacturing process may remain. There are strict limits and controls for the presence of these residual fragments to ensure that there is no effect on the safety or effectiveness of the vaccine.

With regard to part (i), 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.

With regard to part (j), Health Canada is not considering regulating mRNA vaccines as gene therapy products, as these vaccines cannot modify genes. Gene therapy involves the use of genes as medicine to treat genetic disease where the faulty gene is fixed, replaced or supplemented with a healthy gene so that it can function normally. The new gene has to enter the cell nucleus. The mRNA from the vaccines does not enter the cell nucleus or interact with the DNA at all, so it does not constitute gene therapy. Furthermore, vaccines must meet the high standard of quality, safety and efficacy for medicinal products. Consistent with the international approach to regulating these products, Health Canada will continue to regulate mRNA vaccines as vaccines.

With regard to part (k), Health Canada initially authorized the 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 September 2023.

As a regulator of vaccines, 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. In the manufacture of any vaccine, it is expected that there may be variabilities or residual elements that are part of the standard manufacturing process. To manage this, Health Canada requires strict quality limits and controls for the presence of these residual fragments to ensure that the vaccine continues to be safe and that any residual fragments are inactive and have no functional role in the vaccine. All versions of the Pfizer and Moderna vaccines that have been marketed in Canada continue to meet the strict quality standards required by Health Canada. Health Canada takes immediate action should any marketed vaccine product be found to be non-compliant with regulatory standards in Canada.

[Innovation, Science and Industry, December 15th, 2023]

Madam Speaker, the member opposite knows that this agency was created 20 years ago and operates at arm's length. I am not sure what the member is saying. Is he saying that if the Conservatives were in government, he would be interfering and managing the organization or is he saying that if he saw malfeasance, he would do what we did, which is to immediately call people in to review what has occurred?

What this is really about is the Conservatives being against taking action on climate change and being beholden to a base that has MAGA values.

[Carbon Pricing, December 15th, 2023]

Madam Speaker, I think it is essential that we be straight with people who are going through difficult times. Those difficult times are felt all over the world. The fact that Canada is doing better than just about any other country in the world is cold comfort to people who are suffering.

What they need are solutions, like dental care so that seniors can get the dental care they need and one million children can get the dental care they need. Of course, the Conservatives voted against that. Not taking action on the climate and cutting support for vulnerable people is really what this is about.

[Government Priorities, December 15th, 2023]

Madam Speaker, that is why it is so important to work together. There is no point in simply criticizing, raising a fuss or creating problems. I really like it when other parties come up with solutions, because times are tough right now, all over the world. It is time to work together, to find solutions like dental care and the other results this government has delivered for all Canadians.

[Dental Care, December 15th, 2023]

Madam Speaker, there is good news. Dental care will be accessible to everyone across the country, Quebeckers and Canadians alike.

That is good news, and I am wondering why the Bloc Québécois is angry about it. It really is good news for everyone. Of course, there are some details to iron out, and we are going to talk to Quebec to make sure that we get the right results, but our goal is to improve the quality of health care across the country.

[Dental Care, December 15th, 2023]

Madam Speaker, I wish you happy holidays and a merry Christmas.

It is clear that the Bloc Québécois is the one looking for a fight. Our government is the one looking for solutions to ensure that everyone, everywhere in the country, can have access to dental care.

I have had good conversations with Quebec's health minister, Minister Dubé, and I am confident that we can find productive solutions to ensure that dental care is available everywhere.