THE medicines watchdog has revealed it knew two years ago that a child flu vaccine withdrawn last year had been linked to a high rate of fever in children, but it took no action at the time.
Therapeutic Goods Administration national manager Rohan Hammett told a Senate estimates hearing yesterday that CSL had advised in 2009 of a study that showed the rate of fever in children using the vaccine had nearly doubled to 39.5 per cent between 2005 and 2006.The watchdog took no immediate action because the fevers were mild or moderate, and for decades the flu vaccine had been considered safe, Mr Hammett said.
Researchers were examining the 2009 study in light of the high rate of febrile convulsions that occurred with last year's child flu vaccine, which triggered fits in one in 100 children.
Despite referring the 2009 study to the TGA, CSL has not updated its own product information to include the new data.
The TGA has asked CSL -- which recently left Australia with just two weeks' supply of a key penicillin drug -- to explain what it knew of problems with the child flu vaccine and when it learned of them.
The committee heard CSL was being audited monthly after a number of problems were identified at the company's plant by the US Food and Drug Administration and the TGA.
The FDA's audits last year and this year of CSL, released to The Australian last month, cite a string of "objectionable conditions and practices" used by CSL to make vaccines.
They included the failure of laboratory staff to wear masks while dispensing and mixing vaccines, "deficient" tests to check whether viruses were properly split to prevent side-effects and "inadequate" investigations of product failures.
Mr Hammett said the TGA's audits had found problems at CSL but they did not affect product safety.
CSL chief executive Brian McNamee said the firm was "talking" to the FDA every month and was "working diligently" to resolve its concerns. "So we need to document better some of our processes and we are working hard to ensure we have training of all of our staff," he said after the CSL's annual general meeting in Melbourne. "We have a very experienced staff from an Australian and a European regulatory perspective but we need to do a lot more to make sure we meet the FDA's requirements (from a) training, documentation and validation perspective."
No comments:
Post a Comment