The Regulation of Vaccines for Human Use in Canada

Who regulates vaccines in Canada?

Health Canada is the regulatory authority in Canada responsible for working to maximize the quality, safety, and efficacy of all biologic drugs, including vaccines for human use. The Biologics and Genetic Therapies Directorate (BGTD), within the Health Products and Food Branch (HPFB) of Health Canada, is responsible for Canada's vaccines regulatory program in collaboration with the HPFB Inspectorate and the Marketed Health Products Directorate.

How are vaccines regulated in Canada?

Canada, like many other countries, exercises tight regulatory oversight over vaccines because they are usually given to very large numbers of healthy individuals. Vaccines in Canada are subject to the  Food and Drugs Act and the  Food and Drug Regulations. Vaccines are regulated under a specific set of regulations for a subset of drugs known as biologic drugs.

Why are vaccines considered unique?

Vaccines differ from chemical drugs because of the biological nature of the source materials (such as those derived from microorganisms and viruses), the biological methods used to test them and because they are highly complex substances. Some vaccines consist of live microorganisms suitably changed to ensure that they no longer produce disease but can still produce a suitable immune response. Special expertise and procedures are needed for their manufacture, control, and regulation. Vaccines are also unique in that they are often recommended as part of Canadian public health programs, which means they are administered to very large numbers of healthy people, including infants and children; thus safety and quality are paramount.

How are vaccines authorized for sale in Canada?

Before a vaccine can be submitted to Health Canada to be considered for approval, sufficient scientific and clinical evidence must be collected to show that it is safe, efficacious and of suitable quality. This scientific evidence includes results from human clinical trials. For clinical trials performed in Canada, a clinical trial application must be filed to BGTD.

When a manufacturer believes that they have sufficient scientific and clinical evidence about the vaccine, a New Drug Submission (NDS) is filed to BGTD. The NDS should demonstrate the safety, quality, and efficacy of the vaccine. In addition, information regarding the manufacturing facility, the method of manufacture and quality control of the vaccine is included in the submission.

Prior to market authorization, BGTD staff may conduct an on-site evaluation to assess the quality of the manufacturing process and to determine that the manufacturer is able to carry out the necessary quality controls for the vaccine. The manufacturer must also provide samples of three to five consecutive batches or "lots" of the vaccine for testing in the laboratories of BGTD. This allows BGTD to ascertain that the manufacturers can consistently produce high quality lots of vaccine. Clinical studies are reviewed to ascertain that no significant safety concerns have been identified and that the vaccine is able to elicit an adequate immune response in vaccinated subjects.

If, after completion of the review, the conclusion is that the benefits of the vaccine outweigh any risks, then the vaccine is issued a Notice of Compliance (NOC) and a Drug Identification Number (DIN) indicating that it is authorized for sale in Canada.

How are seasonal influenza vaccines authorized for sale in Canada?

There are unique challenges associated with the development and regulatory evaluation of influenza vaccines. The influenza virus strains circulating the globe change on a regular basis and the composition of the vaccine must be modified each year to include new circulating strain(s). As such, the process for influenza vaccine development starts off on a global scale annually. Each year, the World Health Organization (WHO) selects influenza virus isolates which form the basis for influenza vaccine production for the following fall and winter flu season.

Given the short timeframe between the identification of the strain composition by a WHO expert committee and the need to use the vaccine to protect Canadians, an abbreviated market authorization process with expedited review timelines is used to regulate these vaccines. It is important to note that the abbreviated market authorization process with expedited review timelines at no time compromises the safety of the vaccine to be used by Canadians.

The seasonal influenza vaccines are authorized each year via the filing of manufacturing and quality data and revised labelling material. Close coordination is needed between the manufacturers and Health Canada. The Health Canada publication, Access to the Seasonal Flu Vaccine in Canada: How the flu shot makes its way from the laboratory to the doctor's office, describes the pathway for the development, regulation and distribution of seasonal influenza vaccines in Canada.

Are all vaccines authorized?

Vaccines are authorized for sale by Health Canada only after undergoing rigorous reviews to maximize their quality, safety, and efficacy. If there is insufficient evidence to support safety, efficacy or quality claims, BGTD will not authorize the vaccine, and the product cannot be sold in Canada. In certain situations, such as public health emergencies (e.g. influenza pandemics), special authorizations may be used to provide emergency access to a vaccine.

Once a vaccine is authorized, how is it monitored?

Risk-based lot release program

As in other major jurisdictions such as in the United States and Europe, vaccines are subject to an ongoing lot release evaluation after approval. In the majority of cases, for each lot of vaccine to be sold in Canada, the manufacturer must submit the results of its own testing as well as samples for independent evaluation by BGTD. If a vaccine lot meets specifications, a formal Release Letter is issued which approves the sale of that lot in Canada.

Manufacturers of biologic drugs, including vaccines are also required to submit a Yearly Biologic Product Report (YBPR). This annual report is used to assess the ongoing quality of the vaccine, and to highlight any trends. The lot release program and the YBPR are tools which enable Health Canada and the manufacturer to monitor consistency in the vaccine manufacturing process.

Post-market changes

After a new vaccine has been authorized for sale, it is not uncommon for sponsors to make changes to its manufacturing process or to its indication for use. For example, a sponsor may make improvements to the manufacturing process over time or provide evidence to support the use of the vaccine in a different age group. Any proposed changes that may have an impact on the quality, safety, efficacy or effective use of the vaccine are reviewed by Health Canada before they can be implemented by the manufacturer.

Post-market surveillance

Maximizing the quality, safety, and efficacy of vaccines is well recognized as an essential component of any successful immunization program. With this level of regulatory oversight, vaccines have an excellent safety record. However, even when the best regulatory controls are in place, adverse events, which are very rarely serious may occur. Surveillance systems are used to monitor any potential adverse events following immunization. A combination of mandatory and voluntary reporting is used in Canada. The Food and Drug Regulations require manufacturers of all drugs, including vaccines, to report serious adverse events that occur in Canada as well as serious unexpected adverse events that occur internationally within 15 days of receiving the information via the Canada Vigilance Program. Manufacturers also develop annual safety summary reports. The HPFB Inspectorate performs post-market reporting compliance inspections to assess compliance with regulatory requirements for post-market reporting.

The Public Health Agency of Canada is responsible for the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), a spontaneous reporting system in which health care providers (mainly public health nurses and physicians) report adverse events following immunization to local, provincial/territorial public health authorities. Provinces and territories issue guidance to their health care providers on what to report, with an emphasis on reporting temporally associated events that are serious or unexpected or unusual as well as those that are expected but occurring more frequently than usually observed. In addition to this voluntary reporting system, the Public Health Agency of Canada funds an active, pediatric hospital based surveillance system that closely monitors admissions for selected adverse events of particular importance.

Compliance and enforcement activities

The HPFB Inspectorate performs compliance verifications as well as investigations of potential health hazards and other violations. In addition, regular inspections of manufacturers, packagers/labellers, testing laboratories, importers, distributors and wholesalers of vaccines are conducted to ensure that they comply with Good Manufacturing Practices (GMP). When deemed necessary, enforcement action may be taken by the Inspectorate in accordance with their Compliance and Enforcement Policy.

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