Influenza A (H1N1) vaccine example

Canada's national regulatory authority (NRA) is Health Canada. The Public Health Agency of Canada conducts pharmacovigilance for vaccines in collaboration with public health authorities in the provinces and territories and maintains the national database of reports of AEFIs.

Through the vaccine-safety monitoring system, the Public Health Agency of Canada identified a higher than normal rate of anaphylaxis linked to one particular lot (Lot 7A) of a newly released adjuvanted H1N1 flu vaccine. In collaboration with Health Canada and pending further investigation of serious adverse event reports linked to Lot 7A, unused vaccines from this lot were withdrawn from use during the investigation.

This document shows an example of an AEFI reporting form that would be used for investigation. This one is from the Public Health Agency of Canada; the form for your own country may be different. This demonstrates the importance of clearly defined roles and close coordination between organizations responsible for pharmacovigilance and NRAs.