Fever data omitted from Fluvax PI
DATA indicating CSL Limited’s Fluvax was triggering cases of fever in children as early as 2006 was omitted from the vaccine’s product information, according to an article in the MJA.
A trial of the 2005 formulation of Fluvax in children aged six months to three years found 22.5% later experienced a fever, and this rose to 39.5% when same-age children received the 2006 version.
A similar jump was seen in those aged 3–9 years, with the rate of fever increasing from 15.6% in 2005 to 27% in 2006, including one case of febrile convulsion.
However, only the 2005 data were included in the PI for the 2010 Fluvax, according to the MJA article.
Peter Collignon, professor of infectious diseases at the Australian National University, said this was concerning and the TGA should require that the PI be up to date.
“It strikes me that the product information ought to reflect the latest data,