June 1, 2010
The action comes after Australia’s Health Department suspended its seasonal flu vaccine program and launched an investigation on April 23 after reports that hundreds of children suffered side effects including convulsions, vomiting and fever after receiving their annual inoculation.
The department’s Theraputic Goods Administration released interim findings Tuesday that said most of the adverse reactions were associated with CSL’s Fluvax vaccine.
It ordered CSL, one of the world largest vaccine manufacturers, to insert a new warning on Fluvax and Fluvax Jr. alerting medics about the risk of convulsions and fevers when it is used on young children.
In statement, CSL said it would comply with the directive and continue investigations with Australian authorities to find the cause of the problem.
“As a further precautionary measure…CSL has voluntarily commenced a retrieval program for its remaining 2010 paediatric influenza vaccine from medical clinics and distributors,” it said.
Australia’s Chief Medical Officer, Jim Bishop, said a ban on healthy children receiving the flu vaccine would remain in place.
He said only children at risk of serious health effects if they contracted influenza would be considered for the injection, and even then only after careful consideration.
Mr. Bishop said the investigation found the rate of febrile convulsion in infants aged under five treated with Fluvax was about 9-in-1000.
“The expected rate would be less than 1-in-1000,” he said.
CSL said it had manufactured influenza vaccine for 40 years and the company placed the utmost importance on patient safety and the quality of its products.
“The reports we have seen this season in children under five are unexpected and not consistent with our experience using previous seasons’ vaccines,” said Darryl Maher, CSL’s medical and research director.
Mr. Bishop said laboratory testing of the vaccine by the TGA and an audit of CSL’s manufacturing plant had revealed no abnormalities to explain the situation.
“However this investigation is continuing,” he said.
Doctors should also exercise caution using the Influvac vaccine, manufactured by Solvay S.A., and Sanofi-Pasteur S.A.’s Vaxigrip on young children because they haven’t been used widely enough in Australia to determine the rates of convulsions, Mr. Bishop said.
“Influenza itself often causes fever in young children which can lead to convulsions and flu vaccine can also produce these side effects but there is a clear signal that the rate of fever with convulsions is higher with this year’s vaccine across all jurisdictions,” he said.