Australia. Trivalent flu shots suspended after kids hospitalised, fatality

[Giuseppe]

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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[Sally Furniss]

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&#174;.

"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&#174; 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

[Giuseppe]

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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[tetano]

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

[tetano]

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/news/health-science/queensland-health-officials-withheld-flu-death-details/story-e6frg8y6-1225858535586?from=public_rss

[Ronan Kelly]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Hunter toddler's severe reaction to flu shot on eve of its suspension
BY ALISON BRANLEY
27 Apr, 2010 04:00 AM
A HUNTER toddler who received a seasonal flu shot had a severe reaction to the vaccine just one day before it was suspended for children under five.
Hunter New England Health confirmed last night that a young child was admitted to a Hunter hospital on Thursday after having a fever and convulsions within 12 hours of a flu shot on Wednesday.

Public Health Physician Dr David Durrheim said the child had recovered and was now home.

Australia's chief medical officer Jim Bishop suspended seasonal flu shots on Friday after dozens of babies and young children, mostly in Western Australia and Queensland, were admitted to hospital, many with high fevers and convulsions.

Dr Durrheim said one in 10 children who had a seasonal flu vaccine would get a fever.

"Generally they are mild but on occasions it is a high fever but the child will get better," he said.

"Among all children between six months and age six who get fevers 3 per cent will get a fit.

"It's distressing for parents and for health workers but generally it will be shortlived."

He said the suspension of vaccinations for young children was appropriate while authorities investigated whether adverse events were greater than normal.

However, Dr Durrheim said vulnerable people and children over five should still get the seasonal flu vaccine shots, which contained vaccines for three strains of flu, including swine flu.

Those with concerns could get a straight swine flu shot, he said.

GP Access chief executive Mark Foster said children over five with increased risk factors such as respiratory illness, asthma, heart problems, immune deficiency or similar, should still get the flu vaccine.

"They are more at risk of getting the flu and complications of the flu," he said.

"Even children who do not have those increased risks, the flu vaccine includes the swine flu and the swine flu is a significant illness."

http://www.theherald.com.au/news/local/news/general/hunter-toddlers-severe-reaction-to-flu-shot-on-eve-of-its-suspension/1813110.aspx

[Giuseppe]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Seasonal flu vaccine banned in Australia, N.Z. after kids fall ill

[Source: Kyodo, View Original Article.]

A seasonal influenza vaccine used in Australia and New Zealand has been suspended after a recent spike in the number of young children suffering adverse reactions to it. On Friday last week, Australia's Chief Medical Officer Jim Bishop warned doctors to stop giving the Fluvax seasonal influenza vaccine to children aged 5 and under until a cause for the reactions is discovered.
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[german-docter]

Re: West-Australien 22.April 2010: Staatliches Impfprogramm gegen SAISONALE Influenza wegen Nebenwirkungen (Fieber und Fieberkr?mpfe) bei Kindern bis zum Alter von 5 Jahren ausgesetzt.

but the seasonal vaccine contains the "pandemic" vaccine

http://www.fludb.org/brc/vaccineRecommend.do?decorator=influenza

2010 Southern Hemisphere(WHO Selection Document)
Recommended
A/California/07/2009(H1N1)-like virus
A/Perth/16/2009(H3N2)-like virus
B/Brisbane/60/2008-like virus

I. WHO Empfehlung f?r die Zusammensetzung des Grippeimpfstoffes f?r die Saison 2010 auf der S?dhalbkugel:

http://www.who.int/csr/disease/influenza/200909_Recommendation.pdf

- A/California/07/2009(H1N1)-like virus
- A/Perth/16/2009(H3N2)-like virus
- B/Brisbane/60/2008-like virus





II. Offizielle Produktinformation zu Grippeimpfstoff CSL Fluvax junior (Australien):

http://secure.healthlinks.net.au/content/csl/pi.cfm?product=cspfluvj11109

For season 2010
NAME OF THE MEDICINE
Fluvax? Junior vaccine
Inactivated influenza vaccine (split virion)
DESCRIPTION
This is a purified, inactivated, split virion (split virus) vaccine each 0.25 mL of which contains antigens
representative of the following types:

- A/California/7/2009 (NYMC X-181) (A/California/7/2009 (H1N1) ? like) 7.5 μg haemagglutinin per dose
- A/Wisconsin/15/2009 (NYMC X-183) (A/Perth/16/2009 (H3N2) ? like) 7.5 μg haemagglutinin per dose
- B/Brisbane/60/2008 (B/Brisbane/60/2008 ? like) 7.5 μg haemagglutinin per dose






III. Offizielle Pressemitteilung von CSL Biotherapies Deutschland (Marburg) vom 1. M?rz 2010 f?r die Zusammensetzung des adjuvansfreien Grippeimpfstoffes Afluria f?r die Grippesaison 2010/2011:

http://www.apotheke-adhoc.de/Branchennews/9739.html

http://www.aerztezeitung.de/medizin/krankheiten/infektionskrankheiten/influenza_grippe/article/592592/csl-biotherapies-gibt-grippe-impfstoff-bekannt.html?sh=7&amp;h=178514083

CSL Biotherapies 01. M?rz 2010
Pressemitteilung
CSL Biotherapies gibt Virusst?mme f?r saisonalen Grippe-Impfstoff Afluria? bekannt
(?)
Der Grippe-Impfstoff Afluria? 2010/2011 wird folgende Virusst?mme umfassen:

- A/California /07/2009 (H1N1)-?hnlicher Virusstamm
- A/Perth/16/2009 (H3N2)-?hnlicher Virusstamm
- B/Brisbane/60/2008-?hnlicher Virusstamm




Hinweis:
CSL Biotherapies war Lieferant des H1N1-Influenzaimpfstoffes, der (frei von Adjuvantien und Konservierungsstoffen) im (sp?teren) Verlauf der H1N1-Pandemie 2009 speziell f?r die H1N1-Impfung von Schwangeren in Deutschland bereit gestellt worden war:

SCHWEINEGRIPPE-IMPFSTOFF
CSL Biotherapies versorgt Risikogruppen

http://www.op-marburg.de/Lokales/Wirtschaft/Wirtschaft-lokal/CSL-Biotherapies-versorgt-Risikogruppen

[SusanC]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

So are these adverse events related to the CSL seasonal vaccine only, or is there any indication that vaccines made by others are also involved? (I see that there's reference to avoiding the CSL vaccine and using another, but I'd like to see more sources if anyone finds them, thanks!!)

It's a very important question because if it's just one company, it may be a production (or even batch) problem, but if it involves products from other companies, then there may be something intrinsically related to the combination of antigens, with implications for vaccines all over the world!!

I've just been re-reading about the CDC investigation of the Cutter incident in 1955, (in the book Beating Back the Devil) with the inactivated polio vaccines causing polio, when the crucial question was the same - was this the problem with one manufacturer? Or something wrong with the formulation? Turned out in that instance it was just the vaccine from Cutter which had not been sufficiently filtered to remove clumps that contained still viable virus particles.

see also http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1570077/

[SusanC]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

To clarify, a more important question is whether vaccines from any other company have been used in substantial numbers at all, in Australia and NZ. If, for example, CSL is the major supplier, then it's much harder to determine if this is an isolated incident related to the CSL product, or whether there is something going on with the combination of antigens.

The same combination is going to be used worldwide. Most countries do not require testing when the antigen contents are altered from year to year (except for Europe, but their required tests only cover adults, and in small numbers) , but in hindsight, since we haven't had a new pandemic virus since 1968, before the widespread use of such trivalent formulations, it would have been prudent to test the combination.

If indeed it turns out there IS a problem with the vaccine (and it's a big if, because there are lots of potential confounders to be teased out) then we are in fact staring at an issue that has been raised repeatedly by vaccine safety advocates, which is, that the safety of vaccines given in combination has not been fully demonstrated. We've always just assumed that combined vaccines are as safe as single jabs, but there is no systematic research to settle the question. A very unsatisfactory state of affairs that gives fuel to the anti-vaccination lobby, IMO.

[Ronan Kelly]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Flu vaccine maker denies 'bad batch' DANNY ROSE
April 27, 2010 - 5:49PM


AAP

The maker of the flu vaccine now implicated in a rash of child sickness across Australia - and possibly one death - denies that a "bad batch" is involved.

A spokesperson for Melbourne-based pharmaceutical company CSL says a check of available batch numbers listed on adverse reaction reports had indicated no single batch could be responsible.

West Australian health authorities have now received more than 250 reports of child sickness linked to the vaccine.

A two-year-old Brisbane girl has died but Queensland's chief health officer says an initial autopsy has shown no sign that the vaccine was to blame for the death.
However further tests are underway in that state.

GPs nationwide have been told to temporarily stop administering the vaccine to children aged under five.

"CSL is continuing to work with the Therapeutic Goods Administration (TGA) and WA Health to urgently investigate the adverse event reports," the CSL spokesperson told AAP on Tuesday.

"What we have been able to analyse so far indicates that it is not batch related ... our evidence shows it was not a bad batch."

The spokesperson said CSL was now working to finalise numbers on how many doses of its FLUVAX vaccine were sent to WA.

WA was the only state to offer a specific program offering the injections for free to healthy children under five, which may account for its higher rate of adverse reactions compared to other states.

The lack of a problematic batch indicates that other factors - such as practices at immunisation clinics - are likely to be drawn into the TGA's investigation.

WA started its pediatric vaccination program on March 19, and related adverse reactions among children have included vomiting and high fever leading to fits or convulsions.

A one-year-old girl remains in a serious but stable condition in Perth's Princess Margaret Hospital after receiving the vaccine.

Queensland's coroner is investigating the tragic case of toddler Ashley Jade Epapara, a two-year-old who was found dead in her cot on April 9 just 12 hours after receiving the seasonal flu vaccine.

All state and territories have been asked to provide data on other possible cases of adverse reactions in children, though a TGA spokesperson said the problem appeared to be centred on WA.

"To date, the pattern and rate of adverse reactions reported by WA have not been seen in other states," the spokesperson told AAP.

"The TGA has contacted the vaccine suppliers 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."

The spokesperson said the investigation would take in the content of the vaccine as well as "factors related to the program delivery in WA".

Seasonal flu vaccines are made available ahead of every Australian winter, and their make-up is dictated by the World Health Organisation.

These vaccines are trivalent - they offer protection against three influenza virus strains expected to be in circulation.

This year's seasonal flu vaccine offers protection against the A(H1N1) swine flu, along with an Influenza B strain and an A(H3N2) virus.

CSL is the major distributor and the only Australian-based maker of the vaccine though versions can also be imported into Australia by rival pharmaceutical companies.

http://news.smh.com.au/breaking-news-national/flu-vaccine-maker-denies-bad-batch-20100427-tnxs.html

[Missouriwatcher]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

From above post:
"This year's seasonal flu vaccine offers protection against the A(H1N1) swine flu, along with an Influenza B strain and an A(H3N2) virus."

[sharon sanders]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

Thank you everyone.

I made a copy to this thread of a post by German-doctor that shows the label from the manufacturer.

[Vibrant62]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

To clarify, a more important question is whether vaccines from any other company have been used in substantial numbers at all, in Australia and NZ. If, for example, CSL is the major supplier, then it's much harder to determine if this is an isolated incident related to the CSL product, or whether there is something going on with the combination of antigens.

The same combination is going to be used worldwide. Most countries do not require testing when the antigen contents are altered from year to year (except for Europe, but their required tests only cover adults, and in small numbers) , but in hindsight, since we haven't had a new pandemic virus since 1968, before the widespread use of such trivalent formulations, it would have been prudent to test the combination.

If indeed it turns out there IS a problem with the vaccine (and it's a big if, because there are lots of potential confounders to be teased out) then we are in fact staring at an issue that has been raised repeatedly by vaccine safety advocates, which is, that the safety of vaccines given in combination has not been fully demonstrated. We've always just assumed that combined vaccines are as safe as single jabs, but there is no systematic research to settle the question. A very unsatisfactory state of affairs that gives fuel to the anti-vaccination lobby, IMO.

If it transpires that this cannot be attributed to a bad vaccine batch or contaminant, I would suggest that it would also be very important for the Aus and NZ authorities to determine if these children were also given any other vaccinations at the same time as their seasonal flu vax, even though it may be in different arms. Also, they may need to check if these children had received previous swine flu jabs.

One further thought - surely if this were to be a problem with a contamination, we would be seeing problems in other (child) age groups, as I believe that this is a vaccine aimed solely at children? Can anyone verify if this is or is not the case?

[Emily]

Re: Australia. Trivalent flu shots suspended after kids hospitalised, fatality

There could be a simple explanation as to why all the adverse reactions are in WA. That seems to be where the most very young children were vaccinated.

http://www.tga.gov.au/alerts/medicines/fluvaccine.htm

Western Australian reports of adverse reactions to 2010 seasonal flu vaccine in children

23 April 2010
Related information

* Seasonal flu vaccine and young children
Department of Health and Ageing media release
23 April 2010

The Therapeutic Goods Administration (TGA) is investigating reports of an increase in adverse events to the seasonal flu vaccine in Western Australia (WA), where all children 6 months to 5 years have been offered a free seasonal flu vaccination.

The pattern and rate of adverse reactions reported by WA have not been seen in other states, and the TGA will test batches of the vaccine used in WA for any abnormalities.

Other states and territories seasonal flu vaccination programs have focused on individuals in high risk categories.

The TGA is investigating the WA data to determine whether the adverse reactions reported in WA relate to the vaccine, or the WA program delivery.

However, until it can be established what is causing the rise in adverse events in some children in WA, Australia's Chief Medical Officer, Professor Jim Bishop, is writing to all immunisation providers to advise them not to administer seasonal flu vaccinations to all children 5 years of age and under until further notice.