UPDATE from the SMH of Sept. 26:PUBLIC health experts have called for an independent body to monitor drug safety after it emerged that young children were more likely to end up in hospital because of side effects from a flu vaccine than they were from the disease itself.The analysis contradicts government safety advice that the harm did not outweigh the risk and raises concerns about the Therapeutic Goods Administration's assessment of the vaccine.More than 1000 adverse responses in children under five were reported to the TGA by June this year, including nearly 100 instances of febrile convulsions, a seizure which in a small number of cases has been associated with long-term adverse health outcomes.
The side effects were linked to one of the three seasonal flu vaccines, Fluvax and Fluvax junior, from the drug company CSL, but the TGA maintained despite that, that "the overall risk-benefit balance of both products remains positive".
But research published yesterday in the journal Eurosurveillance showed Fluvax might have caused two to three hospital admissions due to seizure for every admission from flu it prevented.
The chief executive of the Public Health Association of Australia, Michael Moore, said further examination of risks was needed, at arm's length from the TGA. The government should consider creating an independent centre.
"There is a concern … that the TGA is the body that approves vaccines and is also the body that determines what the risks and benefits are when concerns are raised," he said.
Peter Collignon, an infectious diseases expert at the Australian National University, said the vaccination program in children under five did more harm than good. "The TGA made that decision [about risk-benefit] without any evidence to back it up."
... Professor Bishop (Commonwealth chief medical officer) told the Herald yesterday that while the rate of convulsions linked to Panvax was about four times higher than the usual experience with flu vaccinations, it was not comparable with Fluvax, where the convulsion rate had been 50 times higher...Dr. Meryl says "DUH?!" Panvax only quadruples seizures in kids, while Fluvax increases seizures by a factor of 50. This is supposed to assuage my concerns about Panvax? Why doesn't the Commonwealth tell the public how many healthy children die or become disabled by influenza each year? For the 4 years prior to 2009-10, less than 100 children died each year from influenza in the US, and most were probably chronically ill to start with. Australia's population is about 1/15th of the US. An extrapolation suggests 4 children die each year from flu in Australia, and probably 2 or 3 are chronically ill. How many seizures is it acceptable to cause to prevent 4 deaths? How many other, unidentified vaccine injuries can be caused as acceptable collateral damage? Where is the risk/ benefit balance?
UPDATE 2 from the Wall Street Journal:
EUROPE and the US have banned an Australian-made flu vaccine for young children, after a surge in febrile fits in Australian children.
The US Advisory Committee on Immunisation Practices has taken stronger action than Australia's Health Department, by recommending that children younger than nine not be vaccinated with CSL's seasonal flu vaccine.
Europe has followed Australia's decision to suspend the CSL vaccine only for the under-fives...
Australian health authorities suspended the use of CSL's seasonal flu vaccine, Fluvax, for the under-fives in April, after it was found to trigger febrile fits at nine times the normal rate.