Ramifications of adverse events in children in AustraliaBMJ 2010; 340 doi: http://dx.doi.org/10.1136/bmj.c2994 (Published 09 June 2010) Cite this as: BMJ 2010;340:c2994
- Peter Collignon, infectious diseases physician and microbiologist1,
- Peter Doshi, program in history, anthropology, science, technology and society2,
- Tom Jefferson, coordinator3
- 1School of Clinical Medicine, Australian National University, PO Box 11, Woden, ACT 2607, Australia
- 2Massachusetts Institute of Technology, Cambridge, MA 02139, USA
- 3Cochrane Vaccines Field, Rome, Italy
Many serious adverse reactions to this year’s seasonal influenza vaccine have occurred across Australia, and its use remains suspended in children aged 5 years and under.1 2 3 Data released on 1 June 2010 show that 1 in every 110 young children vaccinated with the CSL vaccine had a febrile seizure.3
A previous H1N1 vaccine study published earlier this year showed that a large proportion of children developed fevers after vaccination: between three and six in every 10 children under 3 years, depending on dose.4 The study was, however, underpowered to detect febrile convulsions at the current rates in Australia because it included only 162 children under 3 years.
Fever is the most important risk factor for febrile convulsions. The vaccine manufacturer CSL, which sponsored the trial, and Australia’s regulatory body, the Therapeutic Goods Administration, which used these data in approving the vaccine for children, were presumably aware of these important findings.4 But the authors did not discuss the high incidence of fever associated with vaccination,4 and most data were reported without comment in the online only supplementary tables.4
The many children with adverse effects and the subsequent suspension of the vaccine challenge the assumption that regulators are ensuring the safety and efficacy of all marketed therapeutics. Influenza vaccine is said to have “an established record of safety in all age groups.”2 However, published data on the effects of vaccinating young children against influenza are comparatively few.5 Some manufacturers have even withheld data from public scrutiny amid general indifference.2 5
Last winter the likelihood that a child without risk factors would die from swine flu was less than one in a million.2 When such a high proportion of children develop moderate to severe febrile reactions to the influenza vaccine, more harm than good seems likely from vaccinating them.
Cite this as: BMJ 2010;340:c2994
Competing interests: TJ is author of the relevant Cochrane reviews.