Intercountry workshop on causality assessment of adverse events following immunization : 18-20 February 2014, Bangkok, Thailand
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AbstractWith the introduction of new vaccines in the national immunization programme, countries in South-East Asia Region have implemented activities to strengthen vaccine safety post-marketing surveillance also called adverse events following immunization monitoring (AEFI). Consequently, the number of AEFI reports has significantly increased. National AEFI committees established to review serious AEFI cases have all in the last three years been re-organized with additional expertise. This workshop on causality of AEFI was organized for participants from the National AEFI committees to share their experience on implementing vaccine safety surveillance system, report on the status of the system in their countries and to conduct causality assessment on nine selected cases which occurred in the Region between 2011 and 2013. All the cases were anonymized and reports were reorganized to facilitate reading of investigation reports. Out of the eight cases reviewed by the participants, one was Guillain-Barre Syndrome (GBS), one was indeterminate because of lack of information and six coincidental, although they were reported as adverse reaction associated with vaccine. Detecting and reporting AEFI is very important in national immunization progammes but cases need to be periodically reviewed by an expert committee in order to accept or reject the hypothesis that the vaccine causes the reaction. Serious AEFI are very rare and most of AEFI cases reported are often coincidental and reporting these cases without proper causality assessment could potentially undermine public confidence in vaccine and the national immunization programme. At the end of the workshop, countries understood the importance to conduct regular AEFI causality assessment in order to identify true and false AEFI cases.
World Health Organization, Regional Office for South-East Asia. (2014). Intercountry workshop on causality assessment of adverse events following immunization : 18-20 February 2014, Bangkok, Thailand. WHO Regional Office for South-East Asia. http://www.who.int/iris/handle/10665/205375