Ensuring Vaccine Safety and Effectiveness for Canadians

"Immunization is currently considered a cornerstone of public health practice in Canada. Fortunately, given the tremendous potential for immunization in terms of contributing to “public good”, currently available vaccines have a favourable safety record; most side effects are minor and serious complications are rare. Yet the continued success of immunization programs in Canada requires a comprehensive, effective and efficient vaccine safety system, including ongoing pre- and post-licensure testing and regulatory controls, as described in Paper 4, as well as vigilant post-market assessment of adverse events following immunization (AEFI), described herein. While manufacturers typically conduct Phase IV studies to evaluate vaccine safety and/or efficacy – and are also required by law to report serious AEFI – the majority of post-market vaccine safety reporting is conducted by health providers and public health authorities, as part of the extensive Public Health Agency of Canada (PHAC) surveillance framework". - Ensuring Vaccine Safety and Effectiveness for Canadians (Part 9 of Vaccine White Paper Series)