Health Product InfoWatch - May 2017 - Page 3

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Vaccine safety quarterly summary

Report for July 1, 2016 to September 30, 2016

Post-market surveillance is essential to monitor the safety and effectiveness of vaccines and other health products. The monitoring of the safety of vaccines is a shared responsibility between Health Canada and the Public Health Agency of Canada (PHAC). Market authorization holders are required to report serious adverse events following immunization (AEFIs) to the Canada Vigilance Program in the Marketed Health Products Directorate at Health Canada. The Canada Vigilance Program also receives voluntary AEFI reports from healthcare professionals and consumers. Provincial and territorial public health authorities report AEFIs from publicly funded vaccine programs to the Canadian Adverse Events Following Immunization Surveillance System (CAEFISS) in PHAC to monitor the safety of immunization programs.

This Vaccine Safety Quarterly Summary includes AEFI reports received by the Canada Vigilance Program between July 1, 2016 and September 30, 2016. To access reports published by CAEFISS, please visit the CAEFISS Web site.

  • From July 1, 2016 to September 30, 2016, the Canada Vigilance Program received 73 reports* of adverse events following immunization (AEFIs) for which vaccines were the suspected cause.
  • There were 45 (62%) serious reports. Most of these involved patients with underlying medical conditions and were unlikely related to the vaccination.
  • The largest proportion of reports (serious and non-serious) involved herpes zoster vaccine (33%) followed by pneumococcal vaccines (19%) and influenza vaccines (8%).
  • The most frequently reported AEFIs (serious and non-serious) included pyrexia, injection site erythema, pain in the extremity, and drug ineffectiveness. Cases of drug ineffectiveness included those that lacked sufficient information for adequate assessment. The other AEFIs are common following vaccination and are captured in the respective Canadian product monographs.
  • No new safety signals (potential safety issues) were identified during this period.
  • The benefits of vaccines authorized in Canada continue to outweigh the risks.
  • Health Canada, in collaboration with PHAC, will continue to closely monitor the safety of vaccines authorized in Canada.

For additional information, contact the Marketed Health Products Directorate.

Note that because of updated information received by the Canada Vigilance Program, there may be differences in the number of AEFI reports and adverse events retrieved at different dates.

* Glossary of Fields in the Canada Vigilance Adverse Reaction Online Database

This summary may contain duplicate reports. Duplicate reports are reports related to the same patient and event received from more than one source (e.g. pharmacist and consumer). Therefore, the sum of all reports in the line listing may exceed the total number of individual patient cases.

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