The Health Department has exposed drug company "inconsistencies" but ruled them out as the cause of fits in children given a flu vaccine. CSL's world-first combination of seasonal and swine flu strains was suspended for the under-fives in April, after it triggered febrile convulsions in young children at nine times the usual rate. The Health Department's drugs regulator, the Therapeutic Goods Administration, yesterday circulated the latest findings of a six-month investigation into the vaccine scare, pointing to an unusually high level of protein in CSL's Fluvax vaccine. The TGA revealed that its audits of CSL's laboratory in Melbourne in May and June had observed "a number of inconsistencies with good manufacturing practices", to be followed up in a third audit next month.
"The TGA . . . was satisfied that the observations did not present an increased risk to the quality, safety or efficacy of CSL's vaccine products. [Seizures are not a safety problem?!!]
The TGA said an investigation led by Nobel laureate Peter Doherty had not found a conclusive cause of the convulsions. But the "current working hypothesis" was that the strain of swine flu used in this year's seasonal flu vaccine appeared to contain a higher than usual level of a protein called neuraminidase. "Excess neuraminidase enzyme activity may be pyrogenic (producing fever) and may thus be contributing to the increase in febrile reactions in young children receiving the vaccine for the first time," the TGA said.
The TGA also revealed it would continue its suspension of Fluvax for healthy under-fives next year. "Despite extensive analysis, the biological basis for the excess cases of fever and febrile convulsions remains unclear, and it is therefore important to effectively mitigate the risks by limiting exposure to those at greatest risk," it says.
Liberal senator Concetta Fierravanti-Wells yesterday called on the TGA to release details of audits that found deficiencies in 136 of the 139 laboratories manufacturing medicines in Australia. "We must have more transparency," Senator Concetta Fierravanti-Wells said.