Special consideration is needed for the application of sequential analytic methods to assess the safety of seasonal and pandemic influenza vaccine in an ongoing basis. Due to the annual change in the components of the seasonal influenza vaccine, to expected changes in the components of pandemic influenza vaccines, and to the short influenza vaccine seasons, it is often necessary to start vaccine safety monitoring anew each season, and to identify potential risks for adverse events in a timely manner once a vaccine season starts.
Regardless of the methods used, active safety surveillance is not intended to provide conclusive evidence of causality. Rather, it is a method to quickly detect potential associations between a drug or vaccine and a potential adverse event. Therefore, safety signals (potential associations) generated by adverse event surveillance need further study to determine whether the signals are real or spurious.
As part of its pandemic preparedness activities, FDA’s Center for Biologics Evaluation and Research (CBER) initiated a joint collaborative project with Harvard Pilgrim Health Care with the goal of developing documents describing methodologies for use of electronic health data for both seasonal and pandemic influenza vaccine safety monitoring, specifically for the implementation and validation of near-real time surveillance of vaccine adverse events.
The attached documents, prepared by the Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, in collaboration with the Office of Biostatistics and Epidemiology at CBER, FDA, are part of CBER’s pandemic preparedness effort.