Abstract
Australian and New Zealand health authorities identified seasonal trivalent inactivated influenza vaccines manufactured by CSL Biotherapies as the probable cause of increased febrile convulsions in children under five within 24 hours of vaccination and recommended against their use in this age group. We quantified the benefit-risk profile of the CSL vaccines using the number needed to vaccinate and suggest they might have caused two to three hospital admissions due to febrile convulsions for every hospital admission due to influenza prevented.
Highlights
The recognition of an unexpectedly high number of febrile convulsions in children aged less than five years within 24 hours of receipt of trivalent inactivated influenza vaccine (TIV) in Australia in April 2010, led to the initial suspension of the childhood vaccination campaign for seasonal influenza in our country [1]
The number of children living in Western Australia aged between six months and four years in 2009 was approximately 130,000 of whom 30.3% were estimated to have received at least one dose of TIV in that year
If the hospitalisation rate for influenza in 2010 was the same as that in 2009, we estimated that vaccination with Fluvax or Fluvax Junior in 2010 may have caused two to three hospital admissions due to febrile convulsions for every hospital admission due to influenza prevented
Summary
The recognition of an unexpectedly high number of febrile convulsions (not defined precisely initially) in children aged less than five years within 24 hours of receipt of trivalent inactivated influenza vaccine (TIV) in Australia in April 2010, led to the initial suspension of the childhood vaccination campaign for seasonal influenza in our country [1]. The increase in febrile convulsions was first recognised in the state of Western Australia [4] This was possible because at the beginning of 2008 Western Australia had implemented a vaccine programme aimed at immunising children aged from six months to four years against influenza [5]. Influenza vaccine coverage of 20%–30% had been achieved in this age group for 2008 and 2009 and in 2010, prior to the suspension of the programme
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