H1N1 vaccine safety monitoring: beyond background rates

Abstract

Since its emergence early this year, the H1N1 2009 influenza A virus has achieved pandemic proportions. Vaccines have been produced by several manufacturers and mass-vaccination campaigns are underway in the USA and several other countries. Scrutiny of the safety of H1N1 vaccines is expected to be intense. With potentially hundreds of millions of people being vaccinated, adverse events will inevitably occur in some recently vaccinated people and the question will arise as to whether the vaccine was causative. Monitoring the safety of pandemic H1N1 vaccineSteven Black and colleagues (Dec 19, p 2115)1 highlight the importance of developing locally relevant background rates of disease to aid assessment of pandemic H1N1 vaccine safety. Taiwan has the capacity to monitor H1N1 vaccine safety during mass immunisation campaigns. Full-Text PDF Importance of background rates of disease in assessment of vaccine safety during mass immunisation with pandemic H1N1 influenza vaccinesBecause of the advent of a new influenza A H1N1 strain, many countries have begun mass immunisation programmes. Awareness of the background rates of possible adverse events will be a crucial part of assessment of possible vaccine safety concerns and will help to separate legitimate safety concerns from events that are temporally associated with but not caused by vaccination. We identified background rates of selected medical events for several countries. Rates of disease events varied by age, sex, method of ascertainment, and geography. Full-Text PDF