Original language of petition: English
The Government of Canada recognizes that vaccination is an important and valuable public health measure to protect the health of Canadians. The goal of Canada’s pandemic response is to prevent serious illness and death while minimizing societal disruption caused by the COVID-19 pandemic. While vaccines are not mandatory in Canada, safe and effective COVID-19 vaccines can help achieve this goal.
Immunization allows individuals to protect themselves from vaccine-preventable diseases, and supports the greater good by protecting families, close contacts, communities and society as a whole. Decisions on the use of vaccines, reporting of vaccination status, and eligibility to receive publicly funded vaccinations are made at the provincial/territorial level. None of Canada’s provinces or territories currently have a policy of mandatory vaccination for any disease, nor has this approach ever been taken in Canada. Some provinces and territories require mandatory reporting of vaccinations for school entry, but this is to increase the ability of public health officials to respond during an outbreak. Vaccination is a personal choice and Canadians should feel empowered to make their own informed choices.
All vaccines used in Canada are regulated by Health Canada and must meet rigorous standards for safety, efficacy and quality before their use is authorized. Health Canada regulates the drug approval process under the Food and Drugs Act (FDA) and its regulations, and all drugs, including biologic drugs (also known as biologics), are regulated based on rigorous standards of evidence.
Health Canada regulates vaccines for human use in Canada by applying strict requirements, which are informed by science and are aligned with international standards. The review teams for drugs, including COVID-19 vaccines, are comprised of experienced regulatory and scientific experts that make recommendations based solely on scientific evidence. Health Canada reviewers are scientists and physicians with many years of experience reviewing vaccines, and with expertise in different domains including, but not limited to, clinical medicine, toxicology and pharmacology, biochemistry, virology, immunology, microbiology, and other scientific disciplines relevant to the development, testing and manufacture, and quality control of vaccines.
For COVID-19 vaccines, the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 introduced new regulatory mechanisms to expedite the authorization of COVID-19 drugs, including vaccines, while protecting the health and safety of Canadians. These mechanisms have enabled Health Canada to review and authorize COVID-19 vaccines as quickly as possible without compromising on safety, efficacy, and quality. Guidelines for COVID-19 vaccines were developed in alignment with international regulators and the World Health Organization (WHO). The guidelines call for the minimum standards of efficacy and safety, ensuring that the number of vaccine recipients and length of safety follow up are sufficient, and efficacy is demonstrated.
Health Canada is working closely with domestic and international partners to anticipate and meet Canadians' health product needs. This involves discussing, collaborating, and leveraging resources on multiple issues, including vaccine safety. Notably, Health Canada is an active member of the International Coalition of Medicines Regulatory Authorities (ICMRA) and medicine regulators from Australia, Canada, Singapore, Switzerland, and the United Kingdom (ACCESS) Consortiums. Health Canada upholds the WHO-ICMRA joint statement on the need for improved global regulatory alignment on COVID-19 medicines and vaccines, promoting the most rigorous, evidence-based regulatory practices by supporting the alignment of regulatory processes across all countries. The Department also follows the Access Consortium statement on COVID-19 vaccines evidence, which delineates the requirements for safety, efficacy, quality, and pharmacovigilance activities for COVID-19 vaccines.
Regulatory authorization of a vaccine, including COVID-19 vaccines, requires a submission from a manufacturer that includes substantial evidence of safety and efficacy from several clinical trials, as well as evidence of manufacturing quality. The Department conducts an in-depth review of the required evidence for safety, efficacy, and quality of the vaccine before an approval is issued. Health Canada requires that clinical trial results be generated from properly designed protocols so that safety and efficacy of vaccines can be well demonstrated, such as whether the appropriate immune response to prevent a disease is elicited. The Department also requires manufacturing data demonstrating consistency and quality in production of the vaccine.
To further support Health Canada’s efforts to monitor the safety of COVID-19 vaccines, the Interim Order provides the authority to impose terms and conditions on an authorization at any time, such as risk mitigation measures and additional assessments of safety, efficacy, and immunity information. This means that Health Canada can require further information from the manufacturer as well as require the submission of additional information to ensure that the benefits of the vaccine continue to outweigh the risks.
Health Canada is committed to ensuring that regulatory decisions are independent, and based solely on science and evidence. As well, the Department is committed to openness and transparency in sharing information with Canadians. When an external advisory body is instituted to provide advice to the Department, Health Canada ensures that its members do not have direct interests related to the body’s work, and that relevant affiliations and interests are disclosed publicly to the extent possible.
Specifically, the Health Canada Policy on External Advisory Bodies includes a chapter on affiliations and interests. Per this policy, a potential member must complete and submit the Affiliations and Interests Declaration Form within the period set out by the advisory body Secretariat before appointed to an advisory body. A potential member must use the form to disclose all affiliations and interests, including any direct financial interests and other affiliations and interests that relate to the mandate of the advisory body. These might include financial support received from a commercial enterprise, participation in an activity sponsored by a commercial enterprise, or published or publicly stated points of view related to the advisory body's mandate.
As part of the Department’s continued commitment to openness and transparency, Health Canada publishes detailed information about the authorized COVID-19 vaccines on the Department’s COVID-19 Vaccines and Treatments Portal, including Canadian product monographs, and regulatory decision summaries, which provide a high-level summary of the evidence that was reviewed to support the authorization of the vaccine.
As with all vaccines, Health Canada will continue to monitor the safety and efficacy of COVID-19 vaccines once they are on the market and will not hesitate to take action if any safety concerns are identified. Canada has a strong post-market safety surveillance system in place to detect any adverse events, even years after vaccination. Health Canada and the Public Health Agency of Canada (PHAC) share the responsibility of monitoring the safety of vaccines in Canada. Vaccine marketing authorization holders are required to report serious adverse events following immunization to the Canada Vigilance Program in Health Canada. The Canada Vigilance Program also receives voluntary reports from healthcare professionals and consumers. Health Canada and PHAC also provide weekly updates on reported adverse events following immunization.
Provincial and territorial public health authorities report Adverse Events Following Immunization (AEFIs) from publicly-funded vaccine programs to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) in PHAC to monitor the safety of immunization programs. Health providers are also required to follow local or provincial public health protocols and submit reports to the appropriate jurisdictional authority.
Health Canada continues to monitor safety concerns of marketed vaccine products and update the product monograph, should new safety information emerge. The product monographs can be found in the Drug Product Database. For COVID-19 vaccines, this information can be found in the COVID-19 vaccines and treatments portal. Communication to the public about vaccine safety will continue to be a coordinated approach between all levels of government, healthcare professionals, and vaccine manufacturers.
Vaccinations are administered by trained professionals who follow established protocols. Serious and permanent vaccine injuries are rare in Canada. However, as with any medical product, they can occur. On December 10, 2020, Prime Minister Justin Trudeau announced the creation of a pan-Canadian no-fault Vaccine Injury Support Program (VISP). The VISP will ensure that people in Canada who support public health by being vaccinated have access to financial support should they experience a serious and permanent injury or death as a result of vaccination with a Health Canada authorized vaccine. Building on the model that has been in place in Quebec for over 30 years, this pan-Canadian program will ensure fair and equitable access to support for all individuals vaccinated in Canada. The VISP will strengthen immunization programming in Canada, and bring Canada in line with a growing number of countries who have similar programs in place.
Only validated signatures are counted towards the total number of signatures.
|Province / Territory||Signatures|
|Newfoundland and Labrador||194|
|Prince Edward Island||113|