Pandemic influenza A H1N1 vaccines and narcolepsy: vaccine safety surveillance in action

摘要: The 2009 influenza A H1N1 pandemic placed unprecedented demand on public health authorities and the vaccine industry. Efforts were coordinated internationally to maximise speed of development, distribution, delivery, European Union's novel fast-track authorisation procedures mandated increased postmarketing surveillance monitor safety. Clinicians in Finland Sweden later identified an apparent increase incidence narcolepsy associated with a specific adjuvanted vaccine. After extensive review, Medicines Agency confirmed existence this association, which has since been detected England, Ireland, France, Norway. Assessments causal mechanisms continue. In Review, we discuss how association was detected, present evidence according causality assessment criteria for adverse events following immunisation. lessons learnt emphasise central role alert clinicians reporting suspected reactions, importance robust strategies as crucial components future mass immunisation programmes.