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Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Giuseppe

Emeritus
[Source: Australian Broadcasting Company, http://www.abc.net.au/news/stories/2010/04/22/2880521.htm - Edited.]

Flu shots suspended after kids hospitalised

Updated 3 hours 27 minutes ago [April 22, 2010]

The WA Government has suspended all flu vaccinations for children under five.

In the past 24 hours, 45 children have been taken to hospital suffering high temperatures and febrile convulsions after receiving the vaccination.
The Western Australian Government has suspended all flu vaccinations for children under five while it investigates a spike in admissions to Princess Margaret Hospital in Perth.

The Health Minister, Kim Hames, says 45 children have been taken to hospital suffering high temperatures and febrile convulsions after receiving the vaccination.

Dr Hames says the program will be suspended until the department finishes its investigation.

He says parents who have had their children vaccinated should take precautions.

"If it's longer than 12 hours ago then there is no risk," he said.

"But if it's in the last 12 hours they should make sure that they give their child paracetamol and then take every effort to make sure that the temperature of their child is settled."

Dr Hames says parents can call Health Direct for more information on 1800 022 222.
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Re: Australia. Flu shots suspended after kids hospitalised

Re: Australia. Flu shots suspended after kids hospitalised

Flu vaccine ban for children under 5 after kids fall ill in Perth Rod Chester From: The Courier-Mail April 23, 2010 9:11AM

AUSTRALIAN health authorities have announced a nation-wide ban on children under 5 being vaccinated for the seasonal flu.
The move comes after Western Australian health authorities reported a batch of children under five suffered high temperatures and convulsions after being vaccinated.
Australia's chief medical officer Jim Bishop this morning said the recommendation not to give the vaccine to young children was a ?precautionary measure?.

"Until we know more we've suggested that we don't use that [seasonal flu vaccine] for the moment in children under five," he said on ABC radio this morning."I'm advising all doctors today not to use it until we know a bit more.
"This may be part of the normal pattern once we see the whole picture, or it may be more than we would expect. Therefore I just think it's wise and precautionary not to use it in children under five.
?The first thing is to find out if this is an aberration due to just an aggregation of cases or is something important.
So far health authorities in other states have not reported any problems, however Professor Bishop says that could be because WA has a particularly strong program on encouraging young children to be vaccinated.

Prof Bishop said the van did not extend to the swine flu vaccine that could still be given as a separate injection.

He said other groups at high risk of flu, particularly the elderly and pregnant women, should continue to be vaccinated for the seasonal flu.
Prof Bishop says one of the first steps was to identify whether the problem was associated with particular batches or was a wider problem.

http://www.couriermail.com.au/lifes...all-ill-in-perth/story-e6frer7f-1225857280256
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

Halt flu vaccines to children: chief medical officer April 23, 2010 - 10:14AM


Australia's chief medical officer has told doctors to stop giving the seasonal flu vaccine to children.
The advice follows concerns the vaccine is adversely affecting children's health.

"We suggest doctors and health professionals vaccinating children don't use the seasonal flu vaccine for the moment, until we can get the Therapeutic Goods Administration (TGA) to investigate this in more detail," Professor Jim Bishop told ABC TV.

He said the concerns stemmed from a significant rise in the number of children developing a fever after receiving the vaccine.

Western Australian Health Minister Kim Hames yesterday suspended the state?s free flu vaccination program for children under five, after some recipients went into a febrile convulsion - a fit caused by a high temperature.

??We need more information about what?s happened in WA, but also what we can now find out from all the other states from their experience,?? Professor Bishop said.

??If this has been brought up as a possible side-effect of this drug, then we ought to at least suspend its use until we know more.??

In light of the seasonal flu shot suspension, Professor Bishop suggested children get vaccinated against swine flu instead, because that could be a health risk this winter too.

AAP

http://www.smh.com.au/lifestyle/wel...dren-chief-medical-officer-20100423-tgw1.html
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

More than 60 West Australian children may have had adverse reactions to the flu vaccine, the state's health department says.

West Australian Health Minister Kim Hames announced yesterday that vaccinations for children under the age of five would be halted after a number of reactions to the three-strain vaccine, which includes swine flu.

Australia's chief medical officer Jim Bishop today said health professionals nationwide should immediately stop immunising children under five with the vaccine, as a precaution.

West Australian Health Department chief health officer Tarun Weeramanthri said a higher-than-expected number of reactions to the vaccine, which is offered free by the state government to children under five, had been reported.

The Princess Margaret children's hospital (PMH) had reported 44 children under 10 had presented with febrile convulsions, of which 23 related to the paediatric flu vaccine.

Of the 23 children, 12 were admitted to hospital.

One child is in a critical condition following their reaction to the vaccine.

Dr Weeramanthri said he had few details on the child's condition but that they were "seriously ill".

The average age of children who had reactions to the vaccine was about two years, but children aged between five and 10 also experienced fevers and convulsions.

Dr Weeramanthri said another 40 children under 10 had been taken to other hospitals in the state with febrile convulsions, and work was being done to assess if there was a link to the vaccine.

"Advice from West Australian clinicians has said that there is a consistent clinical picture that they're seeing, with fever and vomiting around six hours and certainly within 12 hours of vaccination," he said.

The West Australian health department is working with other states and territories to compile data, but there have been no reports of a spike in reactions to the vaccine in other states.

"It's important to get an estimate of both how many have been vaccinated and how many children have potentially had reactions," Dr Weeramanthri said.

The department and the Therapeutic Goods Administration had honed in on what they thought the cause of the increased reactions was, Dr Weeramanthri said.

"The Therapeutic Goods Administration is working with the manufacturers on two lines of inquiry," he said.

"One is the data from around the country about where we're getting any signals of increased reactions and which batches went where.

"The second is to actually directly test the batches held by the various manufacturers for any impurities."

There had been no reports of an increased reaction rate to the single pandemic swine flu strain vaccine.

"So whether this is an issue about the combination of antigens ... in this vaccine, which has three parts compared to a single vaccine, is something that TGA is looking at," Dr Weeramanthri said.

"That's the first time that particular antigen has been included, but one must remember that the strains of flu change regularly and so there are regular changes in the formulation of the flu vaccine."

The West Australian Health Department had responded appropriately to the reaction and in a timely fashion, Dr Weeramanthri said.

"As soon as we got information from clinicians, particularly at PMH this week that they were concerned they were seeing something more than what they normally see, and people have to understand there is a normal incidence of febrile reactions after vaccination in children.

"Once we got that information we acted as promptly as we could."

National Centre for Immunisation Research and Surveillance clinical research head Professor Robert Booy said the experience was that children around Australia had demonstrated a good tolerance for the vaccine.

Dr Weeramanthri said he was hopeful a safe vaccination program could be provided once the safety of the vaccine could be ensured.

Case in South Australia

One young child has suffered a convulsive reaction to the seasonal flu vaccine in South Australia, health officials say.

But chief medical officer Paddy Phillips said it was still to be determined if one or more components of the vaccine were the cause of the South Australian case and the spike in cases reported in Western Australia.

"There's no evidence at all that there's any particular linkage, at this stage, to any of the components because we don't even know if it's absolutely linked to the vaccine," Professor Phillips said.

"Clearly there's a suspicion and that's why we're playing it safe and suspending the vaccine for five and unders."


http://www.smh.com.au/national/fevers-in-60-children-linked-to-flu-vaccine-20100423-tinv.html
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

If anyone spots a report that names the vaccine used, please could they post the report even if it appears like a near duplicate of an earlier story? Thank you.
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

<small>APRIL 23, 2010, 7:59 A.M. ET</small> >CSL Suspends Child's Flu Vaccine



ByNEIL SANDS

MELBOURNE—CSL Ltd. halted Australian distribution of its pediatric influenza vaccine Friday and launched an investigation after Australian authorities linked influenza injections to severe adverse reactions in young children.

Meanwhile, shares in the big maker of vaccines and plasma products fell 7.3% Friday, in what traders attributed to unrelated worries about the market after U.S. rival Baxter International Inc. on Thursday slashed its full-year outlook. CSL said it didn't have any reason to alter its previous guidance.

CSL, one of the world's largest influenza vaccine manufacturers, halted vaccine distribution Friday following reports that children have suffered seizures and high fevers after their injections. A company spokeswoman said the injection at the center of the concern was a seasonal vaccine that immunized children against three influenza strains, including H1N1, also known as swine flu.

Australian Chief Medical Officer Jim Bishop suspended influenza vaccinations for all children under five years old. He said health authorities are seeking more information from CSL, the manufacturer, and to confirm which batches of vaccine were used in Western Australia.

Dr. Bishop said the action was a precaution "due to a spike in the number of young children in Western Australia experiencing fever and convulsions following seasonal flu vaccinations."

The Australian Broadcasting Corp. reported Friday that 23 children in Perth have been affected.
CSL said in a statement that it was working with health authorities to investigate the problem. "The company takes the safety and quality of its products seriously and will provide more information as soon as possible," it said.

CSL reported in its half-year results in February that the H1N1 vaccine accounted for 160 million Australian dollars (US$149 million) in sales in its CSL Biotherapies division. For the six months ended Dec. 31, the full company reported a profit of A$617 million on revenue of A$2.42 billion.
Earlier Friday, CSL also issued a statement standing by its full-year profit guidance after its shares plunged on concerns about weakness in the human plasma market. Responding to an Australian Securities Exchange query prompted by the share sell off, CSL said: "The company is not aware of any reason to alter the guidance provided to the market at the time of its half-year results."

/.../

http://online.wsj.com/article/SB100...637432.html?mod=WSJ_business_IndustryNews_DHC
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

http://www.theaustralian.com.au/new...ers-hospitalised/story-e6frg6nf-1225857634415

Flu jab fears grow as toddlers hospitalised

Debbie Guest and Natasha Bita From: The Australian April 24, 2010 12:00AM

CLINICAL tests were never carried out on the latest seasonal flu vaccine - a first-time combination of seasonal flu with the feared swine flu H1N1 - that has left a baby girl fighting for her life in a Perth hospital and sparked fits, fevers and vomiting in up to 60 toddlers across the country.
Health officials were last night trying to determine what had caused the reactions in the children, mostly in Western Australia.

The country's chief medical officer, Jim Bishop, yesterday ordered doctors in all states to stop giving the flu vaccine to children under five.

Professor Bishop said non-swine flu strains in the vaccine may have caused the reactions.

For the first time in the world, the flu shot rolled out in Australia last month combined two strains of seasonal flu, as well as H1N1.

Professor Bishop said the Panvax vaccine - the swine flu jab - was "safe", but said the combined flu shot had been suspended for young children as a "precautionary measure" pending investigation by the Therapeutic Goods Administration, which approved its use last month.

Panvax was tested on 400 children before its release last year, but the combined shot was not subjected to any clinical trials.

CSL, which manufactures both vaccines, has stopped distributing children's doses nationally "to reduce the risk of inadvertent administration in this age group".

One angry West Australian mother, who only wanted to be identified as Sharon, said if officials had acted earlier, the one-year-old girl in critical condition in hospital may never have become sick.

Sharon had three of her four children vaccinated two weeks ago and all three needed hospitalisation after suffering from fevers, vomiting and fits. She said it was a frightening experience after her three-year-old, Alivia, turned purple and began shaking. One of her one-year-old twins, Lateesha, later started convulsing.

Peter Richmond, associate professor at the University of Western Australia's school of pediatrics and child health, said the vaccine was not subjected to trials.

"As with each year's seasonal influenza vaccine, this year's seasonal influenza vaccine isn't subject to specific trials in children before it's used," he said.

He added that three trials of different combinations of seasonal flu vaccines had been conducted in children and no concerns had been raised.

Professor Robert Booy, the director of clinical research at the National Centre for Immunisation Research and Surveillance - who helped supervise the swine flu trials - said the combination of flu strains could not be the cause of the problems.
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

Flu shot fatality - toddler dies 12 hours after having vaccination
By Suellen Hinde
From: The Sunday Mail (Qld) April 25, 2010 1:40AM

?Twins given flu job; Ashley dies
?Authorities caution jab for under-5s
?Girl, 2, was fine 12 hours earlier

A FAMILY is in mourning after their toddler unexpectedly died less than 12 hours after receiving a seasonal flu vaccination.
Two-year-old twin Ashley Jade Epapara had been "perfectly fine" before dying at her Upper Mt Gravatt home, on Brisbane's southside, on April 9. Parents David and Nicole are shattered by the mysterious death of their baby girl. "It's dreadful, it's a very hard time," Mr Epapara said yesterday.

National health authorities have ordered doctors to stop giving seasonal influenza vaccinations to children under five after dozens of serious reactions, including convulsions.

Ashley's death is being investigated by police and the office of the coroner. A spokesman for Brisbane coroner John Lock confirmed yesterday that a report was being prepared.

Mrs Epapara told The Sunday Mail that "tests are being carried out" on her little girl. But the young mother didn't want to comment further as she began shaking and her eyes welled with tears. Ashley's twin sister, Jaime, also received the flu jab at the same time and is believed to have been vomiting the night before her sister died.


Asked whether he or his wife thought the influenza vaccine had anything to do with their child's death, Mr Epapara said: "It's very coincidental."

More than 45 children experienced convulsions and fever, with some having to be taken to hospital in intensive care after receiving the vaccine in Western Australia.

Queensland chief health officer Jeannette Young confirmed 15 children in Queensland had been recorded as having an adverse reaction to the vaccine.

Australia's chief medical officer Professor Jim Bishop said in a statement that the West Australian events were being "urgently investigated by health experts and the Therapeutic Goods Administration".

The World Health Organisation last year said a "small number of deaths" had occurred in people vaccinated for influenza, with 65 million people vaccinated globally.
http://www.heraldsun.com.au/news/na...ving-vaccination/story-e6frf7l6-1225857872979
 
Re: Australia. Seasonal flu shots suspended after kids hospitalised

Re: Australia. Seasonal flu shots suspended after kids hospitalised

Information on CSL's trivalent flu vaccine:
http://www.csl.com.au/s1/cs/auhq/1217017237558/Web_Product_C/1196562642777/ProductDetail.htm

Seasonal influenza vaccine – paediatric adverse events
Seasonal influenza vaccine – paediatric adverse events
Melbourne, Australia — 23/04/2010

CSL Biotherapies is aware of reports of a number of adverse events following influenza vaccination of children. CSL is one of several suppliers of influenza vaccine in Australia.

CSL is urgently investigating these reports in association with the relevant regulatory bodies including the TGA and WA Health.

“As a further precautionary measure and in support of the Commonwealth Chief Medical Officer’s decision advising GPs and immunisation providers to stop giving seasonal influenza vaccine to children under 5 years of age, CSL has taken the action to withhold further distribution of its paediatric influenza vaccine* nationally to reduce the risk of inadvertent administration in this age group” said Dr Darryl Maher, CSL Medical and Research Director.

The company takes the safety and quality of its products seriously and will provide more detailed information as soon as possible.


Download the release:
Seasonal influenza vaccine – paediatric adverse events (0.09Mb)


Media Contact:

Jo Lynch
Hinton & Associates
Phone: 61 3 9600 1979
Mobile: 61 411 208 101
Email: jo.lynch@hintons.com.au




*CSL’s paediatric influenza vaccine is for use in children aged 6 months to 35 months and is presented as a 0.25ml single-use syringe containing the approved seasonal influenza vaccine strains.
http://www.csl.com.au/s1/cs/auhq/1187378853299/news/1255923958227/prdetail.htm
 
Last edited:
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Little girl died in cot after flu jab
Jamie Walker From: The Australian April 26, 2010 12:00AM
THE bereaved father of a toddler who died within a day of receiving the seasonal flu vaccine said last night that he could not believe this was coincidental.
David Epapara spoke out after the Queensland Coroner was called in to investigate the little girl's death, which has intensified concern at the risk of side effects from the vaccine to children under five.

Two-year-old Ashley Epapara was found dead in her cot on April 9, the morning after she and her twin sister were inoculated by the family GP in Brisbane.

Mr Epapara told The Australian yesterday that both children had been "perfectly fine" until they received the combined jab for seasonal flu and swine flu.

"We don't know much about what happened at this stage," he said from the family's Mount Gravatt home, on Brisbane's south side.

"But it seems too much of a coincidence for a healthy girl, after having this vaccine, to just pass away. It is shocking."


About 60 babies and small children, mainly in Western Australia, have suffered fits, fever and vomiting after receiving the new seasonal flu vaccine, prompting Australia's chief medical officer last Friday to advise against its being given to under-fives.

The condition of a seriously ill one-year-old girl in Perth improved yesterday, with Princess Margaret Hospital listing her as serious and stable, an advance on her critical state last week.

Queensland Chief Health Officer Jeannette Young said yesterday there was no proof that the seasonal vaccine was to blame for baby Ashley's death. "Until now, neither Queensland Health nor the relevant national body had been advised of, or were aware of, any death allegedly related to a 2010 seasonal flu vaccination in Queensland," Dr Young said.

"Queensland Health is working closely with the Coroner on this matter.

"Our deepest sympathies go out to the family at this time."

The Australian revealed last Saturday that clinical tests were not carried out on the seasonal flu vaccine, even though it was a first-time mix with swine flu.

Mr Epapara said the twins received their shots at about 3pm on April 8 and there was no immediate sign of anything "out of the ordinary".

Ashley's sister, Jaime, started vomiting at about midnight.

Ashley had slept on, seemingly fine. She was found dead in her cot at about 6.30 next morning, when her mother, Nicole, went to check on the girls.

"They have told us it could take six months for all the tests to be done, and then we will have to start the grieving process all over again . . . it's so tragic for us," the young father said.

Mr Epapara said the family accepted there was not enough known about their baby daughter's death to link it to the flu vaccine. However, it was difficult for the family to believe there was no connection when both children were healthy before being vaccinated.

A total of 23 children have been admitted to PMH in Perth since the middle of last month with febrile convulsions feared to be associated with this year's flu shot. A spokeswoman for PMH said there did not appear to have been further cases since vaccinations for under-fives were suspended on Friday.

Additional reporting: Nicolas Perpitch
http://www.theaustralian.com.au/new...ot-after-flu-jab/story-e6frg6nf-1225858118518
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

A YOUNG child has been treated in Royal Darwin Hospital for fever and convulsions following a vaccination for seasonal flu.

NT Centre for Disease Control director Vicki Krause said the incident happened in the past month, but could not say when.

She said the child was aged "three or four" but did not know whether it was a boy or a girl.

The incident came to light after a two-year-old Brisbane girl died less than 12 hours after having the vaccine.

And more than 45 children have suffered fever and convulsions after having the vaccination in Western Australia.

Health authorities have suspended vaccination of children under five until they can work out whether the vaccination is dangerous for children.

But Dr Krause said adults were still advised to have the vaccination, including pregnant women.

She said side effects were not uncommon.

"We know that in probably about 10 per cent or so people will get a fever following the vaccine, and possibly more in children up to five," she said.

With the Darwin child, Dr Krause said it was not known for sure whether the vaccination caused the fever.

"It was just felt to be a very precautionary measure," she said of the suspension.

There have been at least 15 cases of adverse effects reported in Queensland.

The vaccination covers three strains of flu predicted to be common in the coming year - H1N1 (swine flu), a strain of influenza A and one of influenza B.

http://www.ntnews.com.au/article/2010/04/26/142551_ntnews.html
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Hospitals to review flu vaccine records

<!-- Class 'push-0' just right-aligns the element so that the main content comes first. --><!-- cT-storyDetails --><CITE>April 26, 2010 - 11:24AM</CITE>


AAP

Officials will scour hospital records to determine the extent of bad reactions among children to the seasonal flu vaccine.

Australia's Chief Medical Officer Professor Jim Bishop on Monday said he'd ordered a review of hospitals records to better understand the scope of the problem.

It follows his decision on Friday to suspend seasonal flu shots for children under five after dozens of babies and young children, mostly in Western Australia, suffered bad reactions including fevers and convulsions.

Since then, Brisbane father David Epapara has revealed his two-year-old daughter Ashley was found dead in her cot on April 9, a day after she and her twin sister were inoculated by a GP.

The Queensland Coroner is now investigating the death of Ashley Epapara.
"... it seems too much of a coincidence for a healthy girl, after having this vaccine, to just pass away. It is shocking," Mr Epapara told The Australian newspaper.

Prof Bishop said he only learned of the girl's death on Sunday, and the cause was now a matter for the coroner.

He said he didn't know of any Australian children who had died as a direct result of the seasonal flu vaccine.

But he admitted clinical tests were not carried out on the latest version of the seasonal flu vaccine, which offers protection against Influenza A, Influenza B and swine flu.

"The seasonal flu vaccines have been used for about 40 years with an incredibly good safety record," he told the ABC.

"What we do each year is we don't change the vaccine - the vaccine is essentially the same - but there's very minor genetic changes in some of the strains, as we keep up with the usual change of the flu."

Prof Bishop said the changes didn't necessarily warrant a new round of testing.

He said there was nothing to suggest the swine flu component of the seasonal flu vaccine was the problem.
Tests done purely on the swine flu vaccine, which is available separately from the multiple vaccination that also includes influenza A and B, had not shown any problems.

"It doesn't seem to be causing this problem. We haven't had reports at all of any spike in febrile convulsions for the swine flu (vaccine)," he said.

He said everything possible was being done to determine the scope of problems with the seasonal vaccine.

/.../

More at:
http://news.smh.com.au/breaking-new...review-flu-vaccine-records-20100426-tm4e.html
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Aussies must report flu vac concerns

26th April 2010

AUSTRALIA'S chief medical officer is urging medical staff and parents to immediately report any adverse reactions in children to the seasonal flu vaccine.

Professor Jim Bishop has told the ABC he only learned on Sunday of the death of a Brisbane girl 12 hours after she was given the vaccine.

The Queensland Coroner is investigating the death of two-year-old Ashley Epapara, who was found dead in her cot on April 9.

The previous day she and her twin sister were inoculated by the family GP in Brisbane.

Her father David Epapara suspects the vaccination had a role in his daughter's death.

"We don't know much about what happened at this stage," he told The Australian.

"But it seems too much of a coincidence for a healthy girl, after having this vaccine, to just pass away. It is shocking."

News of the death came after dozens of babies and small children, mostly in Western Australia, suffered adverse reactions to the seasonal flu vaccine, including fevers and convulsions.

Those cases prompted Professor Bishop to issue an alert on Friday, suspending the seasonal flu jab for children under five.

On Monday, he urged medical staff and parents to ensure all adverse affects were reported.

"We would depend on doctors and parents and others to report, and we'd urge them to," he told ABC radio.

He said Friday's alert was likely to result in a spike in reported concerns.

"I think the advantage of having an alert go out on Friday... is that it brings this into sharp effect," he said.

"And therefore we anticipate a high level of reporting and we'd encourage people to report."
/.../

http://www.coffscoastadvocate.com.au/story/2010/04/26/aussies-must-report-flu-vaccine-concerns/
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Flu vaccine records defended by chief


Australia's chief medical officer has defended the safety record of flu vaccinations, as he struggles to determine how many children have suffered bad reactions.

Professor Jim Bishop last week suspended seasonal flu shots for children under five.

He acted after dozens of babies and young children, mostly in Western Australia and Queensland, were admitted to hospital, many with high fevers and convulsions.



He defended the safety record of Australia's seasonal flu vaccination program, but admitted the latest version of the vaccine was not subjected to clinical tests.

"The seasonal flu vaccines have been used for about 40 years with an incredibly good safety record," he said.

"What we do each year is we don't change the vaccine - the vaccine is essentially the same - but there's very minor genetic changes in some of the strains, as we keep up with the usual change of the flu."

Prof Bishop said the changes didn't necessarily warrant a new round of testing, and there was nothing to suggest the swine flu component of the seasonal vaccine was the problem.




"We haven't seen a lot of signals from other states (beyond Western Australia) but that doesn't mean we stop looking for it."

A World Health Organisation expert on Monday cast doubt on suggestions a bad batch of the vaccine may have been to blame, saying the cases involved several different batches.

"If it was a single batch, then you might think that that might be the case," Ian Barr, deputy director of the World Health Organisation influenza centre in Melbourne, told the ABC.

"If multiple batches are involved, then that's less likely I think - but again we still need to wait."

The Australian Medical Association had said the children who experienced adverse reactions might have been victims of a bad batch of vaccine.



http://news.smh.com.au/breaking-new...-records-defended-by-chief-20100426-tm4e.html
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

[Source: Australian Broadcasting Company, <cite cite="http://www.abc.net.au/news/stories/2010/04/26/2882821.htm">Flu vax reactions not from single batch: WHO - ABC News (Australian Broadcasting Corporation)</cite>. April 26, 2010. Edited.]

Flu vax reactions not from single batch: WHO


Dozens of children in Queensland and Western Australia suffered fevers, vomiting and convulsions after being immunised.

That has prompted health authorities to temporarily ban the vaccine for those under five.

In Brisbane, a two-year-old girl died a day after receiving the seasonal flu shot.

Ian Barr from the World Health Organisation (WHO) influenza centre says the cases involved several different batches of the vaccine.

"If it was a single batch then you might think that that might be the case," he said.

"If multiple batches are involved then that's less likely I think - but again we still need to wait."
-
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Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Departmental Media Releases
Seasonal Flu Vaccine and young children


23 April 2010 Due to a spike in the numbers of young children in Western Australia experiencing fever and convulsions following seasonal flu vaccinations, Australia's Chief Medical Officer, Professor Jim Bishop, is advising all GPs and immunisation providers to stop giving seasonal flu vaccine to children five years and under until a cause is established.

"This is a precautionary measure while the matter is being urgently investigated by health experts and the Therapeutic Goods Administration (TGA)," Professor Bishop said.

"Until it can be established what factors are causing the apparent rise in fevers in some children in WA, I am writing to all immunisation providers to advise them not to administer seasonal flu vaccine to all children 5 years of age and under until further notice."

Professor Bishop said the medicines regulator, the TGA, is investigating the WA data as a matter of urgency to determine whether the adverse reactions reported in WA relate to the vaccine, or whether factors related to the program delivery in WA are involved.

"The TGA has contacted CSL Ltd to confirm which batches of vaccine were used in WA and is obtaining samples of the vaccine to test in its laboratories to determine if there are any abnormalities in the batches of vaccine used in WA," Professor Bishop said.

"The TGA will be urgently reviewing data from WA Health about the adverse events and the vaccine distribution data to see if the rates of fever and convulsions are truly higher than expected.

The TGA is convening an expert scientific advisory panel to review the information from WA, and is seeking additional information from the manufacturer, CSL Ltd, and from regulatory colleagues internationally.

"TGA will test batches of the vaccine used in WA for any abnormalities.

"The Department of Health and Ageing has sought advice from the Australian Technical Advisory Group on Immunisation. which is currently reviewing the available information on cases and the Department will be seeking its further advice.

States and territories have been asked to report any adverse events related to seasonal influenza urgently to the Therapeutic Goods Administration.

States and territories have also been asked to provide details on batch numbers and type of vaccine."

Professor Bishop said people over five years of age can continue to be vaccinated against seasonal influenza as per usual. Flu can be a serious disease especially in people who are in high risk categories including people aged 65 years and over; all Aboriginal and Torres Strait Islander people aged 15 years and over and pregnant women.

The Commonwealth Government provides the seasonal flu vaccine free for these at risk groups.

Professor Bishop said that there do not appear to be implications for the swine flu vaccine Panvax®.

"It is safe to have the swine flu vaccine. The TGA’s assessment of clinical trials and the advice of its expert committees is that Panvax® is a safe, effective vaccine for prevention of the H1N1 influenza.

“It is expected that the dominant flu this winter season will be swine flu and the specific Panvax vaccine is available free for all Australians.”

Media contact: Kay McNiece, Dept of Health and Ageing, 0412 132 585

http://www.health.gov.au/internet/main/publishing.nsf/Content/mr-yr10-dept-dept230410.htm
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

[Source: Australian Broadcasting Company, <cite cite="http://www.abc.net.au/news/stories/2010/04/26/2883011.htm">More than 200 WA children sick after flu jab - ABC News (Australian Broadcasting Corporation)</cite>. April 26, 2010. Edited.]

More than 200 WA children sick after flu jab


The Health Department says 55 children have had convulsions after being vaccinated while nearly 200 others have suffered fever and vomiting.

WA's chief health officer says there are now 251 confirmed cases of West Australian children aged under five having adverse reactions to flu vaccinations.

Last week the Health Department placed a temporary ban on flu shots for children under five after reports of children getting sick after being vaccinated.

The Health Department says 55 children have had convulsions after being vaccinated while nearly 200 others have suffered fever and vomiting.

One child is in a critical condition at Princess Margaret Hospital.

Dr Tarun Weeramanthri says confirming the number of cases is a significant step forward in the search for the cause of the adverse reactions.

"We'll now be sharing that information with our colleagues from other states and territories, once that national picture is built up this week we'll know more about whether there is a problem, which areas it is in, what possible causes there are,' he said.
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Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

ELEANOR HALL: Australia's chief medical officer is urging health authorities across the country to examine children's medical records to help determine the extent of adverse reactions to the seasonal flu vaccine.

In Queensland a two-year-old girl died after receiving the vaccine. While there is no evidence yet that the vaccine caused the toddler's death, the coroner is investigating the case. Queensland has also reported 15 other cases of adverse reactions in children under five and there have been several severe reactions reported in Western Australia.

That's prompted the Federal health authorities to ban the vaccine for children under five, as Charlotte Glennie reports from Brisbane.

CHARLOTTE GLENNIE: A two-year-old Brisbane girl died earlier this month within 24 hours of receiving the seasonal flu vaccine. Her parents have said she was perfectly fine before getting vaccinated. Australia's chief medical officer, Professor Jim Bishop has told Radio National's Fran Kelly that he only learned of the case after a report appeared about it in the newspaper.

JIM BISHOP: We learnt about this as did the Queensland authorities yesterday I believe and this is a case of unexplained death for the coroner.

FRAN KELLY: Does it worry you Jim as the chief medical officer that you and the Queensland health authorities didn't know that a child had died in Queensland 12 hours after receiving a flu jab? Isn't that a breakdown in some kind of reporting system?

JIM BISHOP: Well we are, we depend on doctors and parents and others to report and we'd urge them to but I think the advantage of having an alert go out on Friday of course is that it brings this into sharp effect and therefore we anticipate a high level of reporting and we'd encourage people to report.

CHARLOTTE GLENNIE: On Friday Queensland Health revealed that so far this year 15 children aged five and under have experienced adverse reactions to the seasonal flu vaccine. And in Western Australia in the last month 23 children under five have been taken to hospital, suffering fits, fevers and vomiting after they also got the vaccine. One remains seriously ill.

Professor Jim Bishop has issued a nationwide ban on seasonal flu shots for all children under five, while health authorities investigate.

JIM BISHOP: Very occasionally a person having a fit from any reason can have a complication. So as we know with epileptics and others that if you have a fit then it may be something that has a complication. And the sort of things we worry about there is that, you know lack of oxygen to the brain or aspirating food or injuring yourself.

And that's the same with any convulsion so that's why it's important to understand that this is something we've alerted people to. We want parents to take the opportunity to bring the temperature down; we want people to report febrile convulsions after vaccination.

CHARLOTTE GLENNIE: But the deputy-director of the World Health Organization's influenza centre in Melbourne, Ian Barr is advising people not to jump to any hasty conclusions.

IAN BARR: I think it's very early to speculate on the possible cause of this fever and convulsions in kiddies. There are many reasons, or many things that can cause fever and convulsion in children and it's rather unusual that influenza vaccine does that in its modern form.

CHARLOTTE GLENNIE: The seasonal flu jab for people deemed at high risk is coordinated nationally by the Department of Health and Ageing, with vaccinations distributed throughout the country. This is the first time it's been combined with the vaccination for swine flu. But no clinical trials took place. Here's flu specialist Dr Ian Barr again.

IAN BARR: In Australia we don't require that the influenza vaccine, the seasonal vaccine is tested for combinations but they have done that overseas, so they have tested in fact giving a full seasonal vaccine with the swine flu, so four vaccines at once if you like and there were no untoward effects there.

So I think there's a high expectation that the combination of these three viruses will be no different from any other three viruses which we include every year without doing formal safety testing which takes quite a period of time and it is extremely expensive and time consuming.

CHARLOTTE GLENNIE: So in your opinion the fact that it is a combination vaccine would have nothing to do with this situation that we've got at the moment as far as you know now?

IAN BARR: I think that's unlikely to be a factor. Certainly all viruses are slightly different but in terms of how they're produced in the laboratory and tested in laboratory and then made in the commercial scale vaccine production areas, they're all investigated individually for any particular differences in those viruses which might lead to some of these things we're seeing currently, such as fever.

So I think that it's unlikely but I guess we have to wait and see on analysis of these particular batches.

CHARLOTTE GLENNIE: Is it possible that it might have just been a bad batch?

IAN BARR: Ah well I think there is multiple batches involved so I think that's unlikely again, if it was a single batch then you might think that that might be the case but if multiple batches are involved then that's less likely I think. But again we still need to wait.

CHARLOTTE GLENNIE: Federal health authorities say they hope to have more answers by the end of the week.

ELEANOR HALL: Charlotte Glennie reporting.

http://www.abc.net.au/worldtoday/content/2010/s2882792.htm
 
Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

QUEENSLAND Health officials claimed they were unaware of any deaths related to the seasonal flu vaccine, despite launching an investigation two weeks ago into the death of a two-year-old who was immunised the day before.

As suspicions centred on CSL's Fluvax seasonal flu vaccine as the likely link in more than 250 adverse reactions reported nationwide, alarm over the number of children taken ill after receiving a jab has spread overseas, with the New Zealand government warning doctors to avoid CSL's Australian-made product, and to choose one of two alternative vaccines instead.

Queensland Health has come under increased pressure for its public statements over the death of toddler Ashley Jade Epapara.

Queensland's Chief Health Officer, Jeannette Young, said yesterday the department had ordered an "urgent investigation" on April 9 after media inquiries about a two-year-old who had died shortly after receiving a swine flu vaccination.

Start of sidebar. Skip to end of sidebar.

End of sidebar. Return to start of sidebar.

On Sunday, Dr Young said: "Until now, neither Queensland Health nor the relevant national body had been advised of, or were aware of, any death allegedly related to a 2010 seasonal flu vaccination in Queensland."

The two-year-old girl was found dead in her cot on April 9, 12 hours after receiving the seasonal flu vaccine.

On the night of her death, Queensland Health Minister Paul Lucas told a television news program children should continue to receive vaccinations.

The circumstances surrounding the child's death are being investigated by the Coroner.

As Australia's adverse events hotline revealed yesterday that its phones were "running hot" with reports of flu jab reactions from parents nationwide, the New Zealand Health Ministry said it had recorded at least three cases of febrile convulsions following vaccination.

In Western Australia, where a potential spike in cases was first spotted, the number of children under five who have suffered fevers after being immunised has now risen to 251.

On Friday, the Wellington ministry said in a statement that all the cases in New Zealand and Western Australia -- at that stage thought to number about 60 -- involved the CSL-made seasonal flu vaccine Fluvax, a claim repeated yesterday by a New Zealand government official.

The statement recommended children at higher risk be given alternative flu vaccines.

In Australia, Chief Medical Officer Jim Bishop ordered the suspension of all seasonal flu vaccines for children under five, pending further investigation.

A spokeswoman for the federal Health Department said Fluvax was believed to be involved in the West Australian reports of reactions.

CSL has contested the claims, saying three rival vaccines are available nationwide and that investigators have yet to discover which vaccine was given to the affected children.

And flu experts have cautioned that the spike in reactions might yet prove to be illusory, or caused by factors unrelated to the vaccine.

Fluvax is the seasonal vaccine CSL distributes every year, offering protection against three strains of the rapidly mutating virus. For the first time, this year's formulation includes swine flu as one of the three strains.

Panvax, CSL's pandemic flu product, which protects against swine flu only, is not linked to the latest alerts and remains available for adults and children older than six months.

Swine flu is expected to account for most cases of seasonal flu in Australia this winter.

Professor Bishop said he had requested hospital records be reviewed to trace which vaccines children had received and whether they had been tested for other infections, which could trigger fever and convulsions.

Western Australia's Chief Health Officer, Tarun Weeramanthri, said it was increasingly unlikely a single adverse batch of vaccine was to blame, due to the number and spread of reactions.

He said doctors and families of the 55 worst-affected children were being contacted, and he expected to have detailed information by mid-week on exactly which vaccine they received.

Dr Weeramanthri confirmed the WA Health Department in February advised doctors who could not obtain child doses to use half an adult dose, but said that was standard practice and he did not believe it was linked to adverse reactions. The 251 affected children were from an estimated 20,000 to 30,000 vaccines.

http://www.theaustralian.com.au/new.../story-e6frg8y6-1225858535586?from=public_rss
 
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