Abstract

Canada has been known to have one of the better vaccine safety surveillance capacities in the world, but in the early 2000s, it was noted there was still room for improvement. How has Canada done over the last decade and is there more to be done? Canada has done well. First, there has been significant progress made by the Vaccine Vigilance Working Group to enhance the passive vaccine safety monitoring system and address potential issues arising from the review of surveillance data and cases or clusters of concern. Second, there has been an increased investigative capacity for clusters of adverse events and other vaccine safety issues, including an assessment and referral system for individuals with adverse events following immunizations (AEFIs). Third, the use of the Brighton Collaboration definitions and other international standards has facilitated international collaboration and represents the best standard of practice. Despite all these improvements, however, there is more that could be done. The sensitivity of Canada's passive surveillance system still varies from one province and territory to another. The timeliness of the data exchange flow could improve. The AEFI Signal Response Protocol, which identifies the processes and required actions for timely management of any newly detected or emerging vaccine safety signals, is a critical piece of a robust vaccine safety system but it is still in the making. It is commendable that Canada has decided to expand its focus on evaluation research from influenza vaccines to vaccine-preventable diseases more broadly, with the establishment of the Canadian Immunization Research Network (CIRN). CIRN's newly developed Provincial Collaborative Network and the move toward record linkages is excellent. These new investments are welcome in light of the rich vaccine development pipeline, the increased pool of available vaccines, and the growing set of technologies for vaccines production, delivery, and safety monitoring. What would round this all out would be a stronger capacity to monitor the implementation of vaccination programs and vaccine coverage, and better documentation of the reduction of the disease burden attributable to vaccination programs. Canada's investment in vaccines for the health of all deserves no less.

Highlights

  • This special theme issue on vaccine safety is important and welcome

  • There has been significant progress made by the Vaccine Vigilance Working Group to enhance the passive vaccine safety monitoring system and address potential issues arising from the review of surveillance data and cases or clusters of concern

  • There are additional elements that work to ensure vaccine safety in Canada. These include: the international norms and standards and processes for the development, production and quality control of vaccines; the role of the national regulatory authority; the role of the public health advisory bodies on decision making such as the National Advisory Committee on Immunization (NACI), the Canadian Immunization Committee (CIC), and provincial advisory bodies such as the Comité sur l’immunisation du Québec; the supply chain and health delivery infrastructure; and the role of pre- and post-curriculum training and standards set by professional bodies that lead to the following of best practices by health care professionals delivering immunization

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Summary

Introduction

This special theme issue on vaccine safety is important and welcome. It is opportune to review the situation and progress in sustaining and further developing one of the critical elements of the National Immunization Strategy [1] 11 years after its establishment. It is desirable to review how Canada is delivering on one of the key elements of the Global Vaccine Action Plan 2011−2020 of the Decade of Vaccines [2], approved by the World Health Assembly in May 2012, that highlights the importance to detect and promptly analyze serious adverse events following immunization (AEFI). It is essential to inform health care professionals and the public about the processes and activities that are continuously in place to ensure vaccine safety, but often go unnoticed. It is useful to consider if the current system is optimal or if there is more to be done to fill the remaining needs and gaps

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