Febrile convulsions after 2010 seasonal trivalent influenza vaccine: implications for vaccine safety surveillance in Australia

Michael S Gold, Paul Effler, Heath Kelly, Peter C Richmond and Jim P Buttery
Med J Aust 2010; 193 (9): . || doi: 10.5694/j.1326-5377.2010.tb04029.x
Published online: 1 November 2010

Passive surveillance cannot be relied on as the sole means of surveillance

On 22 April 2010, use of seasonal trivalent influenza vaccine in children aged 5 years and under was suspended across Australia, pending an investigation into an apparent increase in reports of adverse events following immunisation (AEFI).1 This unprecedented halt to a national immunisation initiative followed Western Australia’s decision to place a moratorium on the use of this vaccine in young children after observing a spike in emergency department presentations for high fever and febrile convulsions after vaccination.2 A subsequent investigation by the Therapeutic Goods Administration indicated that febrile convulsions related to the vaccine were reported from all jurisdictions except the Northern Territory.2 The apparent rate of febrile convulsions following vaccination was 5–9 per 1000 doses administered, about 50 times higher than that reported following measles–mumps–rubella vaccination.2,3 A recent review, requested by the Minister for Health in WA, has highlighted significant deficiencies in AEFI surveillance.4

  • 1 Discipline of Paediatrics, University of Adelaide, Adelaide, SA.
  • 2 Prevention and Control Program, Communicable Disease Control Directorate, WA Health, Perth, WA.
  • 3 Epidemiology Unit, Victorian Infectious Diseases Reference Laboratory, Melbourne, VIC.
  • 4 School of Paediatrics and Child Health, University of Western Australia, Perth, WA.
  • 5 SAEFVIC, Murdoch Childrens Research Institute, Royal Children’s Hospital, Melbourne, VIC.
  • 6 Department of Paediatrics, Monash University, Melbourne, VIC.

Competing interests:

Michael Gold was a member of the Therapeutic Goods Administration Adverse Drug Reactions Advisory Committee from 2006 until 2009. Peter Richmond has received grants from GlaxoSmithKline for otitis media epidemiological research; grants from CSL for pneumonia research; payment from CSL for sitting on a scientific advisory board for adjuvanted influenza vaccine in 2007; and honoraria from Baxter for chairing and speaking at a meningococcal vaccine workshop in 2008 and speaking at an international scientific meeting in Thailand in 2007. He was also an unpaid member of a Wyeth advisory board on pneumococcal conjugate vaccine in 2008. Murdoch Childrens Research Institute has received payment from CSL for Jim Buttery participating in data safety monitoring boards for influenza vaccine studies and trials, and a grant from CSL for a Guillain–Barré syndrome surveillance study.

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