RESUMO
BACKGROUND: Canada has a comprehensive vaccine safety surveillance system that includes both passive and active surveillance of vaccines administered in Canada. OBJECTIVES: To provide 1) a descriptive analysis of the adverse events following immunization (AEFI) reports for vaccines administered in Canada, 2) a descriptive review of health care utilization and outcome following an AEFI and 3) an analysis of serious adverse events (SAEs). METHODS: Data was obtained from the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS), which includes both passive and active surveillance. Descriptive analyses were conducted of AEFI reports arising from vaccines administered from January 1, 2017 to December 31, 2017 and received by April 30, 2018. Data elements included AEFIs, demographics, health care utilization, outcome, and seriousness of adverse events. RESULTS: There were 2,960 AEFI reports submitted to CAEFISS from across Canada for vaccines administered in 2017. The AEFI reporting rate was 12.6/100,000 doses distributed (8.1/100,000 population) in Canada for vaccines administered in 2017 and was found to be inversely proportional to age. The majority of reports (91%) were non-serious events, primarily involving vaccination site reactions such as rash, and allergic events. Overall, there were 253 SAE reports, for a reporting rate of 1.1/100,000 doses distributed in 2017. Of the SAE reports, the most common primary AEFIs were seizure (n=58, 23%), followed by anaphylaxis (n=33, 13%). 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 in 2017 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.
RESUMO
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.
RESUMO
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 received by the Public Health Agency of Canada by April 30, 2013, for vaccines marketed in Canada and administered from January 1, 2005, through December 31, 2012. RESULTS: The AEFI reporting rate was 10.1 per 100,000 population in Canada for vaccines administered in 2012 and was inversely proportional to age. There was a trend of declining rates from 2005 (14.8) to 2012 overall and by age group. The vast majority of reports (94%-95%) were non-serious involving reactions at or near the vaccination site, rash and febrile events. CONCLUSION: Canada has a strong pharmacovigilance system for vaccines with one of the highest AEFI reporting rates in developed countries. Vaccines marketed in Canada have a very good safety profile. This report enables comparisons across jurisdictions in Canada and globally.