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Cross-posted from the January 2012 GIN issue with thanks. 31/01/2012 from Philipp Lambach, WHO HQ An important part of post-licensure vaccine safety surveillance is to collect and analyse reports of Adverse Events Following Immunization (AEFI). Analysing multiple AEFI reports helps determine if the observed reaction rate to a specific vaccine ishigher than the expected vaccine reaction rate which is often determined from published studies or trials. If a vaccinated group and a placebo group have identical background rates of an event any differences between groups can be attributed to the vaccine, taking into account factors leading to variation of background, observed and vaccine reaction rates of events. To help strengthen the capacity to introduce vaccines in Member States, WHO will publish information sheets online shortly to provide details on selected vaccines that are relevant to the analysis of reported events. These information sheets include a short summary of the vaccine as well as details of mild and severe adverse reactions (local and systemic) following immunization. Where possible, the information presented includes the expected rates of vaccine reactions as published in the literature. The papers primarily target national public health officials and immunization programme managers but may appeal to others interested in such information. Data from these sheets can be used in the evaluation of AEFI reported during national immunization programmes, but also in preparing communication materials about specific vaccines. In total, information sheets of over 20 of the most important licensed vaccines will be developed and gradually posted on our website. If you and your colleagues would like to receive email notification when the first batch of the information sheets is available, you can subscribe by sending an email to: vaccsafety@who.int. Information sheet structure Designed for practical use in the field, the information sheets follow a simple, modular pattern, including information on vaccine specifics and adverse events. The section on Adverse Events usually includes passages in • mild adverse events; • serious adverse events; • other safety issues • summary table for quick overview To satisfy potential further research needs, all sheets include a detailed list of source material.


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