23 April 2013
Fluvax still given to children despite being banned from under-fives in 2010
Some doctors are still mistakenly injecting kids with the CSL-produced Fluvax - three years after it was banned for young children due to the risk of high fevers and fits.
News Limited can reveal that a baby suffered a febrile convulsion and 20 other children recorded such high fevers they could not be given their second dose during a clinical trial that began a year before Fluvax triggered febrile convulsions in 100 children.
AMA president Steve Hambleton says it's concerning if true, as there are four other brands of vaccine safe for children as young as 6 months.
"We do have safe vaccines that we should be using for that age group," he told Network Ten earlier today.
Dr Hambleton said the AMA was very concerned about anything that undermined confidence in vaccination, which saved about 100 million lives each year.
Dr Hambleton said was important for the elderly, very young and children with chronic disease to be vaccinated against the flu.
The 2010 findings
GPs and clinics began mass immunisations at the start of the flu season in March 2010.
Within weeks, Fluvax was banned for the under-fives after triggering febrile convulsions in one in every 100 children - 10 times the expected rate.
The 1992 healthy children involved in the CSL-funded clinical trial were injected between March and August 2009, and data was collated by February 2010.
But the Therapeutic Goods Administration said yesterday CSL did not provide preliminary data until April 26, 2010 - three days after the Chief Medical Officer ordered a halt to the entire immunisation program.
And a synopsis of the findings - which revealed that a seven-month old baby suffered a febrile convulsion, high fever and severe vomiting within four hours of the flu shot - was not given to the TGA until June 2010.
The findings were published this month in the international medical journal, Influenza and Other Respiratory Viruses.
The study recorded 588 episodes of fever, and 26 "serious adverse events", including 19 among children younger than three.
Fluvax caused minor to severe side-effects in nearly 80 per cent of the children, the study team reported, with at least one in four of the youngest children developing a fever after their first dose.
The study team recommended "further research" to understand why the vaccine triggered fevers.
CSL stands by its data and reporting system
CSL spokeswoman Sharon McHale yesterday said all CSL's flu vaccine trials had met international requirements, "including the timely reporting of adverse events and disclosure of clinical trial data to regulatory agencies."
"Febrile events are known side-effects of vaccination in children," she said.
"Based on the clinical data available to CSL at the time, the significant increase in febrile convulsions that occurred in children in 2010 were unexpected and could not have been predicted."
Australian National University microbiologist Professor Peter Collignon - an adviser to the World Health Organisation - said the febrile convulsion and high fevers detected in the clinical trial "should have been a red flag".
The Health Department spokeswoman said drug companies were not required to complete clinical trials before supplying new vaccines because there was not enough time between selecting new flu strains and manufacturing the vaccine. Subs: do not remove
An investigation by News Limited reveals that some doctors have mistakenly given the CSL-produced Fluvax to 11 children in recent weeks,
Two children in Western Australia, three in Queensland, three in NSW, one in the Northern Territory were given Fluvax shots, and Victorian Health is investigating two cases.
The federal Health Department said it was "concerned" doctors had given Fluvax to the under-5s "contrary to very clear instructions".