TGA knew of Fluvax side effects in 2009
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