Serious BCG vaccine-associated complications continue to occur in Canada. The numbers of FNI children with disseminated disease was greater than expected from reported rates in the literature.

Background:To describe the adverse event following immunization (AEFI) reporting profile for vaccines administered in Canada during 2012 and surveillance trends relative to reports for vaccines administered from 2005 through 2011. Methods: Analysis of data based on AEFI reports

Background: Canada has one of the strongest vaccine safety surveillance systems in the world. This system includes both passive surveillance of all vaccines administered and active surveillance of all childhood vaccines. Objectives: To provide 1) a descriptive analysis of the adverse events following immunization (AEFI) reports for vaccines administered in Canada, 2) an analysis of serious adverse events (SAEs) and 3) a list of the top ten groups of vaccines with the highest reporting rates. Methods: Descriptive analyses were conducted of AEFI reports received by the Public Health Agency of Canada (PHAC) by August 14, 2017, for vaccines marketed in Canada and administered from January 1, 2013 to December 31, 2016. Data elements in this analysis include: type of surveillance program, AEFIs, demographics, health care utilization, outcome, seriousness of adverse events and type of vaccine. Results: Over the four year period, 11,079 AEFI reports were received from across Canada. The average annual AEFI reporting rate was 13.4/100,000 doses distributed in Canada for vaccines administered during 2013-2016 and was found to be inversely proportional to age. The majority of reports (92%) were non-serious events, involving vaccination site reactions rash, and allergic events. Overall, there were 892 SAE reports, for a reporting rate of 1.1/100,000 doses distributed during 2013-2016. Of the SAE reports, the most common primary AEFIs were anaphylaxis followed by seizure. Meningococcal serogroup C conjugate vaccines (given concomitantly) were responsible for the highest rates of AEFIs, at 91.6 per 100,000 doses distributed. There were no unexpected vaccine safety issues identified or increases in frequency or severity of expected adverse events. Conclusion: Canada's continuous monitoring of the safety of marketed vaccines during 2013-2016 did not identify any increase in the frequency or severity of AEFIs, previously unknown AEFIs, or areas that required further investigation or research. Vaccines marketed in Canada continue to have an excellent safety profile.

BCG provides protection against severe forms of childhood TB. However, in a country with publicly funded health care and declining TB rates, it is important to consider VAAE. Disseminated BCG infection increases mortality among children with immunodeficiency disorders, which now have successful therapies. Although TB remains a threat in FNI communities, early detection and treatment of TB infection may be a more appropriate intervention.

No abstract