TGA knew of Fluvax side effects in 2009
20th Oct 2011 AAP all articles by this author - Medical Observer
THE TGA has admitted that it knew in 2009 that Fluvax caused higher rates of fever than other trivalent influenza brands but took no action as the side effects were mostly mild or moderate.
An article in the MJA online on Monday raised questions about the fact that data from trials that found a high rate of fever were not included in Fluvax product information in 2010 (MO, 17 October).
TGA national manager Dr Rohan Hammett was questioned at a Senate estimates committee hearing yesterday about adverse events in children receiving Fluvax in 2010, which led to the withdrawal of the vaccine.
Dr Hammett said the TGA was made aware in 2009 of findings from a published trial that 22.5% of toddlers younger than three experienced fever after being given Fluvax in 2005.
That figure jumped to 39.5% in 2006, but only the 2005 data was included in the 2010 Fluvax PI.
Dr Hammett said people were now using a "retrospective scope" to suggest the TGA should have picked up on the problem before the 2010 flu season.
"Indeed in those earlier clinical trials there were rates of fever for the Fluvax vaccine that were higher than some other comparable vaccines," he told the hearing.
"However... most of those fevers were mild and moderate and there was no sign of a febrile convulsion signal."
Dr Hammett said the TGA had written to CSL seeking “to gain a greater understanding of what they knew when".
"We haven't yet received a response," he said.
Liberal senator Concetta Fierravanti-Wells also quizzed the TGA about the US Food and Drug Administration’s concerns about CSL's manufacturing process, including its accusation of an "inadequate" examination of dark particles found in vaccines sold in the US.
"Why are we leaving it to the US FDA to identify deficiencies with CSL?" Senator Fierravanti-Wells said.
"Why isn't the TGA doing that?"
Dr Hammett said the TGA was currently auditing CSL on a monthly basis.
