Vaccine Safety

Vaccine Pharmacovigilance

Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention and communication of adverse events following immunization (AEFI) or of any other vaccine-or immunization-related issues. Post-marketing surveillance of vaccines is undertaken by the Vaccine Safety Section of the Public Health Agency of Canada (PHAC) in collaboration with other key governmental and non-governmental stakeholders. A more detailed description of Canada’s vaccine safety network can be found in the Canadian Immunization Guide, part 2.

Canadian Adverse Events Following Immunization Surveillance System (CAEFISS)

CAEFISS is a Federal/Provincial/Territorial monitoring system with the following objectives:

1. to continuously monitor the safety of marketed vaccines in Canada;
2. to identify increases in the frequency or severity of previously identified vaccine-related reactions;
3. to identify previously unknown adverse events following immunization that could possibly be related to vaccine (unexpected AEFI);
4. to identify areas that require further investigation and/or research; and
5. to provide timely information on AEFI reporting profiles for vaccines marketed in Canada that can help inform immunization related decisions.

AEFI reports are submitted by vaccine and other health care providers to local Public Health Units to enable individual public health action, such as decisions regarding advisability of future immunizations. Provinces and Territories collect AEFI reports as part of ongoing evaluation of their immunization programmes. After removing personal identifiers they forward the reports to the Vaccine Safety Section at PHAC, which collates them into the national CAEFI database for signal detection and analysis. PHAC shares AEFI data with Health Canada to enable regulatory action related to vaccines marketed in Canada. PHAC also receives AEFI reports from some vaccine Market Authorization Holders (MAHs) on a voluntary basis.

Frequently Asked Questions (FAQ)

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