Regulating vaccines for human use in Canada
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Vaccination is one of the world's greatest public health achievements. For over 50 years, vaccines have helped prevent and control the spread of deadly diseases and saved the lives of millions of infants, children and adults. For example, there are vaccines for:
- epidemics, such as Ebola
- childhood diseases and debilitating diseases, such as polio
- diseases, such as Yellow Fever, that are common in some travel destinations
- influenza strains that change every year
- preventing or treating cancer
Many vaccines are recommended as part of Canadian public health programs to prevent people from getting diseases. This means that they are given to large numbers of healthy people.
This is why regulating the safety, efficacy and quality of vaccines is of particular importance. There are also reporting systems in place to monitor vaccine safety.
On this page
- Role of government, health authorities and health care providers
- Regulating vaccines in Canada
- Seasonal influenza vaccines (flu shot)
- Monitoring the quality of vaccines
- Post-market changes
- Post-market surveillance of safety and effectiveness
- Adverse reaction reporting
- Safety summaries, assessments and foreign safety actions
- Emergency access to vaccines
- Compliance and enforcement activities
Role of government, health authorities and health care providers
Health Canada regulates vaccines by:
- evaluating a vaccine for its safety, efficacy and quality based on scientific and clinical evidence
- authorizing only vaccines that are safe, effective and of high quality, and whose benefits outweigh the risks
- monitoring the quality of vaccines authorized for sale in Canada
- conducting post-market surveillance of safety and effectiveness of vaccines authorized for sale in Canada
The Public Health Agency of Canada (PHAC):
- provides information about vaccines and immunization
- monitors vaccine safety through the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)
- funds a pediatric hospital-based national active surveillance network
- closely monitors admissions for selected adverse events following immunization, vaccine failures and selected infectious diseases that are or will be preventable through vaccination
Provincial/territorial health authorities:
- provide vaccines through immunization programs
- issue guidance to health care providers on what to report, with an emphasis on reporting temporally associated events that are:
- serious, unexpected or unusual
- occurring more frequently than usual
- collect and report on adverse events following immunization
- reporting by health care providers is mandatory in 11 provinces and territories
- determine the best vaccine schedule for their region
The National Advisory Committee on Immunization, which reports to PHAC:
- makes recommendations to PHAC for the use of vaccines currently or recently approved for use in humans in Canada
- reviews evidence of the safety and effectiveness of vaccines and issues and updates recommendations on their use
Health care providers:
- provide vaccines to their patients
- answer patient questions about vaccines
- report adverse events following immunization to their local public health unit
Regulating vaccines in Canada
The Food and Drugs Act and its Regulations categorize vaccines as biologic drugs. Biologic drugs differ from chemical drugs because they come from living organisms, which means they are more variable than chemical drugs. Therefore, biologic drugs require more regulatory oversight than chemical drugs, as well as special expertise and procedures for their:
For more in-depth information on regulating biologics, refer to our regulatory roadmap for biologic (schedule D) drugs in Canada page.
Scientific and clinical evidence
When developing a vaccine, scientists collect scientific and clinical evidence to show that it is:
- manufactured to the highest quality
This evidence includes results from the review of manufacturing processes and human clinical trials. To perform a trial in Canada, researchers and manufacturers must file a Clinical Trial Application with Health Canada's Biologic and Radiopharmaceutical Drugs Directorate.
When a manufacturer has enough scientific and clinical evidence of the safety, efficacy and quality of the vaccine, they file a New Drug Submission. This submission provides Health Canada with this evidence as well as information about the:
- manufacturing facility
- method of manufacture
- quality controls for making the vaccine
Safety and efficacy
Health Canada's clinical reviewers thoroughly review the submission to:
- confirm there are no significant safety concerns
- determine that the vaccine is able to prompt an adequate immune response in vaccinated people and thus demonstrates that it can protect against disease
- determine from the safety and efficacy review that the benefits outweigh the risks
- review procedures for safety monitoring outlined by the manufacturer and any plans to minimize any identified risks
A vaccine's efficacy is determined throughout the process of development. Initially, the vaccine must demonstrate an adequate immune response. In later stages of development, the vaccine's efficacy is evaluated for its ability to protect against a developing disease compared to no vaccine or similar vaccines. These vaccine studies, which can involve thousands of people and take many years, help to inform Health Canada's safety and efficacy reviews.
Before Health Canada authorizes a vaccine for sale in Canada, Health Canada's quality reviewers may visit the manufacturing site to:
- assess the quality of the manufacturing process
- make sure the manufacturer is able to carry out the necessary quality controls for the vaccine
Once a vaccine is authorized, the manufacturer must provide vaccine samples from 3 to 5 consecutive lots, for testing in Health Canada's laboratories. This allows Health Canada to find out if the manufacturer consistently produces high-quality lots.
Authorizing a vaccine
Health Canada's Biologic and Radiopharmaceutical Drugs Directorate reviews the data in the submission. When the review is complete, if the benefits of the vaccine outweigh any identified risks, Health Canada issues:
- a Notice of Compliance (NOC)
- a Drug Identification Number (DIN)
These show that Health Canada has authorized the vaccine for sale in Canada.
If there is not enough evidence to support safety, effectiveness or quality claims:
- Health Canada will not authorize the vaccine
- the product cannot be sold in Canada
A list of all authorized vaccines can be found in the Drug Product Database.
After a vaccine is authorized, the manufacturer or health care professionals may continue to generate post-market data supporting additional uses of the vaccine. For example, this could include use in age groups not originally authorized or a new authorized indication. Proposals for a new clinical trial are submitted to Health Canada using a new Clinical Trial Application.
If the manufacturer wants to modify the product monograph to include additional uses, they must submit the safety and efficacy data to Health Canada. In turn, Health Canada may authorize additional uses based on this evidence. The information is reviewed and the monograph is updated. The product monograph is a factual, scientific document that informs health care professionals about the appropriate use of the vaccine.
The National Advisory Committee on Immunization also makes recommendations for the use of currently or newly authorized vaccines by reviewing the evidence and issuing statements.
Seasonal influenza vaccines (flu shot)
Influenza virus strains circulating around the globe change often. Every year, the World Health Organization (WHO) recommends specific vaccine viruses to include in that year's influenza vaccine.
There is a short time between when the WHO's expert committee recommends the flu vaccine viruses and when the vaccine is needed to protect the people of Canada. During the review process, the safety of the flu vaccine that Canadians will use remains of utmost importance.
For more information about the seasonal flu vaccine, please refer to:
- Access to the seasonal flu vaccine in Canada: How the flu shot makes its way from the laboratory to the doctor's office
- Guidance document: Annual update of seasonal influenza vaccines
Monitoring the quality of vaccines
Risk-based lot release program
Vaccines authorized for sale in Canada go into a lot release program where their quality is continually tested and monitored. In most cases, to sell each lot of vaccine in Canada, the manufacturer must submit:
- the results of their own tests
- samples for Health Canada to test independently
If a vaccine lot meets all requirements, Health Canada's Biologic and Radiopharmaceutical Drugs Directorate issues a formal release letter to approve the sale of that lot in Canada. The lot release program enables Health Canada and the manufacturer to monitor consistency in the vaccine manufacturing process.
After Health Canada authorizes a new vaccine for sale, the manufacturer may sometimes want to make changes to either:
- the manufacturing process or
- the vaccine's indication for use
As examples of such changes, a manufacturer may:
- make improvements to the manufacturing process over time
- find evidence to support the use of the vaccine in a different age group
Health Canada reviews any proposed changes that may have an impact on the quality, safety or effectiveness of the vaccine before changes can be made by the manufacturer.
Post-market surveillance of safety and effectiveness
Vaccines on the market in Canada are also monitored continuously for:
Post-market surveillance is a shared responsibility between two federal government departments:
- Health Canada performs a regulatory oversight role for safety, quality and effectiveness.
- PHAC, in collaboration with public health authorities in the provinces and territories, monitors and reports on adverse events following immunization.
Adverse reaction reporting
As with any other health product, an adverse reaction may occur when a vaccine is given. Manufacturers of all drugs, including vaccines, must report to Health Canada within 15 days of receiving information about:
- serious adverse reactions that occur in Canada
- serious unexpected adverse reactions that occur internationally
They submit these mandatory reports to the Canada Vigilance Program (CVP).
The CVP also accepts voluntary adverse reaction reports for vaccines from health care providers and the public. However, health care providers are asked to report any adverse event following immunization to their local public health unit. Health Canada also encourages consumers to report adverse events to their vaccine provider or other health care provider. This information is shared voluntarily with PHAC by the provinces/territories for national monitoring through the AEFISSCAEFISS.
Safety summaries, assessments and foreign safety actions
Manufacturers are required to develop annual safety reports for their products. If a safety summary shows a significant change to a product's safety profile, the manufacturer must notify Health Canada right away.
We may also require manufacturers to prepare and submit issue-related summary reports, in response to new information about their products. We assess these reports to decide if any regulatory action is needed.
Health Canada may order manufacturers to:
- assess their marketed product's risks and benefits
- perform tests and studies to support what is known about a product's safety and effectiveness
Canadian manufacturers must report to Health Canada within 72 hours if a specified foreign country has taken regulatory action in response to serious risks to human health related to their products.
Emergency access to vaccines
In some cases, such as public health emergencies like flu pandemics, special authorizations are used to give emergency access to a vaccine. For example, Health Canada issued an Interim Order in 2009 for the H1N1 pandemic vaccine. The vaccine was developed to protect against the H1N1 pandemic virus. The vaccine contained an inactivated (non-live) version of the H1N1 virus strain recommended by WHO for the manufacture of vaccines during the 2009 flu pandemic.
Compliance and enforcement activities
To protect the safety of the public and prevent deception in relation to vaccines, Health Canada:
- monitors compliance
- undertakes enforcement activities
- addresses non-compliance
Inspectors in Health Canada's Regulatory Operations and Enforcement Branch deliver the national compliance and enforcement program for vaccines authorized for sale in Canada. We may inspect any party conducting a regulated activity. Regulated parties have mandatory responsibilities under the Food and Drugs Act.
Foreign establishments that conduct regulated activities in Canada, or in relation to a vaccine sold, imported or advertised in Canada, are also subject to Canadian law. Regulated activities for a vaccine under the Food and Drugs Act include:
If the Act is contravened, Health Canada uses its enforcement powers to compel or encourage compliance.
For more information on our approach to compliance and enforcement on vaccines, please consult the:
Should you wish to report a complaint to Health Canada about the quality or safety of a vaccine, you may consult:
- International statement about confidence in vaccine safety and effectiveness (for healthcare professionals)
- International statement about confidence in vaccines (for the general public)
- PHAC: Vaccine safety, surveillance and reporting
- Canadian Immunization Guide: Part 2 - Vaccine Safety
- Vaccine safety surveillance in Canada: Reports to CAEFISS
- Immunize Canada
- Vaccine Safety Net (WHO)
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