AEFI Review Committee
Every country should establish an AEFI Review Committee to:
- review individual serious and unusual AEFIs and other AEFIs referred to it by expert groups (e.g. the national immunization technical advisory groupsNational immunization technical advisory groups (NITAGs)Advisory groups whose general objective is to guide national governments and policy-makers to develop and implement evidence-based, locally relevant immunization policies and strategies that reflect national priorities.) and/or national pharmacovigilance centresNational pharmacovigilance centreA governmentally recognized centre (or integrated system) within a country with the clinical and scientific expertise to collect, collate, analyse, and give advice on all information related to drug safety.;
- assess potential causal links between AEFIs and a vaccine (or vaccine lot);
- monitor reported AEFI data for potential signals of previously unrecognized vaccine-related adverse events;
- provide recommendations for further investigation, education, corrective action and communication with interested parties, including the media;
- record its deliberations and decisions and feedback on each reviewed case to all relevant stakeholders.
An AEFI Review Committee should be composed of members that are independent of the NIP and the NRA. It should represent a wide range of specialists whose expertise may add to the task of reviewing the AEFIs. Areas of expertise would include paediatrics, neurology, internist, forensic physician, pathology, microbiology, immunology and epidemiology. Medical experts in particular should be invited for the analysis of special clinical events.
To avoid conflict of interest, the national EPI manager, vaccine laboratory scientists, representatives of the National vaccine regulatory authority, and regional/district EPI officers should not be included as members in the committee, however, should be available to support it in its functions.