PUBLISHED research linking CSL’s influenza vaccine to high rates of fever in children was omitted from the product information for its 2010 Fluvax product, which caused serious adverse reactions in children.
The product information (PI) included data from the 2005 flu season showing that after receiving Fluvax, fever was experienced by 22.5% of children aged from 6 months to less than 3 years and 15.6% of children aged from 3 years to less than 9 years.
However, the PI omitted data from the 2006 season which showed that the rate of fever had increased considerably — to 39.5% in the younger age group and 27% in the older group. Of the 272 children who received the 2006 vaccine, one child in the older group experienced a febrile convulsion.
However, Professor Collignon said it was important to weigh the risks of the vaccine with the risks of influenza itself.
“By my calculations, if more than one child in 1000 has a febrile seizure, the vaccine is doing more harm than good”.
In 2010, Fluvax was found to be causally linked to a significantly increased rate of fevers and febrile convulsions among Australian children. One published estimate put the rate of paediatric febrile convulsions at 3.3 per 1000 doses, or more than 200 times the rate in the only other published population-based estimate. (3)
MJA InSight, 17 October 2011
