Australian Therapeutic Goods
[The TGA is supposed to be Australia's health
watchdog but since they are paid only by drug companies and depend on their
funding to continue in operation, one would not expect them to come down hard on
what is an obvious cover-up by one of their masters - CSL. Please read the
article below from the MJA InSight. Share widely.----From:
Meryl Dorey <email@example.com]
TGA defends Fluvax decision
ALTHOUGH the rates of serious adverse events in a clinical trial of CSL Fluvax
in 2006 were similar to those which led to the suspension of the product in
2010, the Therapeutic Goods Administration says a comparison of the two sets of
data is invalid.
Clinical trial data for the 2006 season showed that two children out of 272
experienced serious adverse events within 24 hours of receiving Fluvax,
including one child who had a febrile convulsion and one who had pyrexia and
This rate of febrile convulsions (1 per 272) is similar to the estimate for the
2010 season (3.3 per 1000) which led to the unprecedented decision by
Australia’s chief medical officer to suspend the use of paediatric flu vaccines.
However, TGA national manager Dr Rohan Hammett told a Senate estimates committee
hearing last week that the 2006 data showed “no sign of a febrile convulsion
A TGA spokeswoman told MJA InSight that a single adverse reaction report
within a clinical study was not usually regarded as an adequate signal of a
major safety problem.
Lead author of the clinical study, Professor Terry Nolan, also told MJA
InSight that the small sample size of the study meant the rates of febrile
convulsions were not comparable with those seen in the community in 2010.
In response to an article last week in The Australian, Professor Nolan,
who chairs the Australian Technical Advisory Group on Immunisation (ATAGI), said
it was not his role to advise the TGA of the adverse events seen in the clinical
“We did a clinical study. It was published in a peer-reviewed journal. The
serious adverse events were notified to the sponsor [CSL]”, said Professor
Nolan, who is also head of the school of population health at Melbourne
The TGA spokeswoman said that CSL advised them of these adverse events as they
occurred, however these events “gave no safety signal”.
CSL did not advise the TGA of all the data in the Nolan paper until May 2010,
and the data has still not been added to the product information, as reported in
MJA InSight last week.
The spokeswoman said that the study was published in 2009 at a time when the
world was facing a potential influenza pandemic.
“In that context, the publication of a study demonstrating that the seasonal flu
vaccine, which had been proven to be safe over 4 decades, had a higher rate of
fever than in some other studies was not a matter of great significance at that
time”, she said.
However, other experts believe the 2006 data should have been acted on,
particularly as the rates of fever in children were almost double what had been
seen in 2005 data from the same study.
“How a government agency can say it didn’t matter that the side-effect profile
was twice what we saw before I find astounding”, said Professor Peter Collignon,
professor of infectious diseases at the Australian National University.
Professor Collignon said the argument that the high rates of adverse events seen
in 2010 were a one-off event linked only to the 2010 seasonal flu vaccine was
“There’s enough evidence to show that at least fevers were occurring at higher
rates at other times”, he said.
He said increases in fever rates, regardless of convulsion rates, were
significant in their own right.
“You don’t have a febrile seizure unless you have a fever”, he said.
Professor Collignon said the bigger issue was the lack of efficacy and safety
data for paediatric flu vaccines in general, based on long-term prospective
studies involving thousands of children.
“Those studies haven’t been done and they need to be done.”
- Sophie McNamara