URL for Flu vaccine - CSL produces its own vaccines, tests its own vaccines, sells its own vaccines and 'investigates' its own vaccines...

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http://www.theaustralian.com.au/national-affairs/health/flu-vaccine-production-methods-triggered-fits-csl/story-fn59nokw-1226403509900

from Meryl Dorey, AVN

CSL produces its own vaccines, tests its own

vaccines, sells its own vaccines and 'investigates' its own

vaccines...They say that what happened could not have

been predicted, but if the vaccine had been properly tested using

acknowledged gold-standard scientific methods such as RCTs, predicting

would not have been a problem. It would have been known about before Saba

Button became brain damaged; before Jade Epapara was killed and

before the hundreds of other children were injured. Where is the

government's duty of care?

Flu vaccine production methods triggered fits: CSL

by: Natasha Bita, Consumer editor From: The Australian June 21, 2012 12:00AM

AUSTRALIAN drug giant CSL has admitted its vaccine production

methods probably triggered seizures in children, in the first results

from its two-year investigation into the Fluvax fits.

But CSL refused to say yesterday if it would pay compensation to the

families of children hospitalised after being immunised with Fluvax,

which has been banned for pediatric use after sending one in 100 children

into febrile fits in 2010.

The preliminary results of CSL's two-year investigation conclude that its

manufacturing methods may have failed to fully split the viruses used to

make flu vaccines.

As a result, gene fragments and lipids from " inactivated virus "

-- as well as " residual whole virus or clusters of both " -- may

have created higher levels of immune-stimulating hormones, known as

cytokines.

" CSL's method of manufacture preserves more short gene fragments and

lipids from the virus than other manufacturers, " the company

stated.

The process, combined with the three new strains of seasonal and swine

flu virus selected to make the 2010 version of Fluvax, " elicited an

excessive immune response in some young children, triggering increased

fever and fever-related convulsions " .

" While influenza vaccines must contain virus components to stimulate

sufficient protection against influenza, it appears that components of

the inactivated virus retained in Fluvax in 2010 overstimulated the

developing immune systems of some young children, " CSL

said.

The company's vice-president of medical and research, Darryl Maher, said

CSL would not change its manufacturing methods until the scientific

investigation was complete. " I'm sure we will be, " he said.

" There is just a bit more work to do. "

Dr Maher said CSL had been using the same vaccine production processes

for 25 years and " it stood us in good stead up until

2010 " .

Asked if CSL would compensate children who suffered severe side effects

from Fluvax, Dr Maher said he could not comment on individual cases.

" I know some of them were very unfortunate and quite tragic, "

he said.

" I think we accept that Fluvax has been a contributory cause of

these reactions; I don't think there is any doubt about that.

" But what happened in 2010 couldn't have been predicted; it was

quite unexpected. There was nothing we could have done to avoid

it. "

The Australian revealed last October that in 2005, a three-year-old child

suffered a fit and became " non-responsive " for up to seven

minutes after being injected with CSL's flu vaccine during a clinical

trial supervised by the federal government's top immunisation adviser,

Terry Nolan.

A second child involved in the trial of 298 children had to be admitted

to hospital for rehydration after high fever and vomiting.

The federal Health Department yesterday said it was " applying close

oversight " to CSL's manufacturing operations. " These findings

justify the government's policy to keep the current ban on the use of

this vaccine in young children in place, " Chief Medical Officer

Baggoley said.

The Australian revealed a year ago that the US regulator, the Food and

Drug Administration, had threatened to revoke CSL's licence, citing

manufacturing deficiencies and an inadequate investigation into the

Fluvax fits.

The FDA chided CSL over " high-risk deviations " in its vaccine

production, including " failure of the viral inactivation

cycle " .

FDA audits accused CSL of " deficient " tests to check whether

viruses were properly split to prevent side-effects. Dr Maher said

" the majority if not all of the findings of last year's inspection

have been closed out by the FDA " .

The federal government recently renewed CSL's contract to supply flu

vaccines under the National Immunisation Program, which gives free flu

shots to the elderly, indigenous people, pregnant women and Australians

with underlying health problems.

Fluvax remains banned for the under-fives, yet dozens of children were

mistakenly given the vaccine again this year -- including a toddler

admitted to intensive care after a febrile convulsion.

Sheri Nakken, former R.N., MA, Hahnemannian

Homeopath

Vaccination Information & Choice Network

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