Canada Vigilance Program

Under the Food and Drugs Act (1985) and Regulations, pharmaceutical companies are legally required to report serious adverse reactions related to a vaccine. The Canada Vigilance Program offers oversight after vaccines have been licensed, with systemic safeguards to ensure that vaccines have continued monitoring. The program includes safety reports, surveillance systems, risk management plans, and product risk/benefit assessments.

Safety Reports

According to the Food and Drugs Act (1985), pharmaceutical companies are required to prepare an annual report that comprehensively analyzes all adverse drug reactions occurring anywhere in the world. Drug companies are also responsible for notifying Health Canada if they become aware of any significant issues that could affect the benefit-risk profile.

Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)

All health professionals must report adverse events following immunization (AEFI) to local authorities, who report to provincial authorities, who in turn report to federal authorities. CAEFISS is responsible for using this information for ongoing safety monitoring and AEFI investigations in Canada. An AEFI may or may not have a causal relationship to the use of the vaccine.

Evaluation of Vaccines Post-License

The safety profile of a vaccine is heavily scrutinized before licensure. Rigorous monitoring and evaluation continues once the vaccine is available to the general population to identify potential rare side effects and frequency of adverse events following immunization. This period is often referred to as the post-marketing period because the vaccine continues to be monitored after it is licensed. Table 4.2 outlines the various stages of post-license evaluations.

Table 4.2: Post-License Evaluation Stages

AEFIs should be reported:

• When the event has a temporal association with a vaccine. A causal relationship does not need to be proven before reporting.
• When the event is serious or unexpected (e.g., life threatening or results in death, requires hospitalization or prolongation of an existing hospitalization, results in residual disability, or causes congenital malformation).
• If there is any doubt as to whether or not an event should be reported, health professionals should always choose to report the event.

Table 4.3 is an example of a protocol for reporting adverse events. Each province and territory has their own reporting system outlining local and provincial/territorial activities. It is important that health professionals know what and how to report in their jurisdiction. The Public Health Agency of Canada has a national reporting form that is available. Completed forms are sent to the local public health unit. All reports are eventually reported up to CAEFISS at a national level.

Table 4.3: Adverse Event Type Requiring Reporting

As a health professional, it is important to monitor adverse events and follow the steps below:

Step 1

• Advise clients to contact you or your team if they experience an adverse event after vaccination.

Step 2

• Complete either the local form or the Public Health Agency of Canada form for reporting an AEFI. A user guide is available.
• Submit the completed form to the local public health unit or consult them if you have any questions.

Attribution Statement

Table 4.3 was adapted with editorial changes from “Adverse Event Following Immunization Reporting for Health Care Providers in Ontario” by Public Health Ontario. Contact the copyright holder for appropriate permission.