The Canadian Context

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Vaccine Approval – Health Canada Biologics and Genetic Therapies Directorate

All vaccines authorized for sale in Canada are reviewed and approved by the Biologics and Genetic Therapies Directorate (BGTD) of Health Canada. Like all medicines, vaccines must undergo rigorous review and testing before they are approved for use. Health Canada also supervises all aspects of vaccine production by the manufacturers to ensure safety, sterility, and quality.

Before a new vaccine can be submitted to Health Canada for approval, its manufacturer must collect sufficient scientific evidence from pre-clinical and clinical human trials (typically carried out over several years) that show the vaccine is safe, effective, and of high quality and that it produces the desired immune response. The manufacturer must then include this evidence along with information on how the vaccine was developed and manufactured, as well as how it will be routinely tested, in a New Drug Submission filed with the BGTD.

As part of the process for approving vaccines, members of the BGTD perform on-site inspections and evaluations of the vaccine manufacturer's establishment(s) to assess the quality of the production process and ensure that the necessary quality controls and internationally recognized Good Manufacturing Practices are being used. The manufacturer must also provide at least three sample batches or "lots" of the vaccine to the BGTD for testing in its laboratories. The BGTD approves a vaccine only when its safety, effectiveness, and quality have been thoroughly proved and when the benefits of the vaccine greatly outweigh any risks associated with it. If the above requirements have been satisfied after thorough review of the New Drug Submission, the on-site evaluation(s), and the independent laboratory testing of samples, the vaccine is issued a Drug Identification Number and a Notice of Compliance indicating that it is approved for sale in Canada.

All vaccines sold in Canada undergo ongoing lot release evaluation even after they have been approved. The manufacturer must submit the results of testing for each lot of vaccine to be sold in Canada and lot samples for independent evaluation by the BGTD. In order to sell new lots of the vaccine, manufacturers must ensure that each new lot is the same in its specific characteristics as the ones tested before authorization was given. This method allows experts to reasonably determine that the new lots are as safe and effective as previous ones. If a vaccine lot meets all required specifications, a formal release letter is issued to approve the sale of that lot in Canada.

Optimal Use – The National Advisory Committee on Immunization

The National Advisory Committee on Immunization (NACI) is an independent committee of recognized experts (in the fields of paediatrics, infectious diseases, immunology, medical microbiology, internal medicine, and public health) that provides expert advice on vaccines to PHAC. After Health Canada authorizes a vaccine for sale in Canada, the NACI evaluates all available scientific information about that vaccine and then makes recommendations about its optimal use. For information on the list of immunizing agents and the companies that have received approval to market them in Canada, consult the Canadian Immunization Guide.

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Immunization Programs – The Provinces and Territories

In Canada, provinces and territories are responsible for the development of publicly funded immunization programs, including the purchase of vaccines. Each provincial or territorial ministry of Health uses NACI's recommendations to develop its program and schedules for children and adults. While the provinces and territories decide which vaccines to purchase, most of the vaccines used in publicly funded immunization programs in Canada are purchased through a bulk purchasing program coordinated by Public Works and Government Services Canada. In some cases, provinces may purchase vaccines on their own behalf. All vaccine purchases must follow a process that is open, fair, and transparent and must respect Canada's obligations under applicable national and international trade agreements. The vaccine procurement process is intended to ensure that equal consideration is given to all eligible vaccines that have met the stringent requirements for approval in Canada.

Post-Marketing Surveillance – Public Health Agency of Canada

After any vaccine is approved to be sold in Canada, mandatory and voluntary post-market surveillance and adverse event reporting occur. Vaccine manufacturers are required by law to report serious adverse events following immunization within 15 days of notification of the occurrence. Public health nurses, doctors, and other healthcare workers in Canada also report these events to the Centre for Immunization and Respiratory Infectious Diseases (CIRID) at PHAC. After removal of any identifying personal information, such events reported at the provincial or territorial level are then referred to the Canadian Adverse Events Following Immunization Surveillance System. Selected serious events, particularly those affecting children, are also reported by the Immunization Monitoring Program – Active (IMPACT). IMPACT is administered by the Canadian Paediatric Society with funding from the Centre for Immunization and Respiratory Infectious Diseases of the Public Health Agency of Canada.

The goal of this national vaccine safety surveillance is to monitor all vaccines used in Canada and to detect, as quickly as possible, any evidence of concern regarding safety. If unexpected or increased side effects due to vaccines occur, the BGTD and CIRID decide on the best course of action needed to resolve these situations.

Effective, Competent Practice – The National Immunization Strategy

The development of the National Immunization Strategy (NIS) was first endorsed by the federal/provincial/territorial deputy ministers of Health in June 1999, under the direction of the Advisory Committee on Population Health. In 2002, the deputy ministers agreed in principle to the concept of a strategy and endorsed the National Immunization Strategy: Final Report in June 2003.

The NIS stipulates the need for continued collaboration and partnerships with federal, provincial, and territorial partners and other stakeholders to improve the effectiveness and efficiency of immunization programs in Canada. In addition, a key activity of the NIS is the development of a national professional education component to support the achievements and maintenance of a safe and competent practice to better protect Canadians from vaccine-preventable diseases.

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