Australia. Trivalent flu shots suspended after kids hospitalised, fatality

[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/lo...lu-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.
-
------

 

[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.

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...rippe-impfstoff-bekannt.html?sh=7&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.

 

[SusanC]

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

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?

I can't verify anything but to answer your question, No, problems may be specific to certain age groups. For example, febrile convulsions (from any cause) typically affect toddlers, but not so much infants under 6 months, nor older children. http://www.ninds.nih.gov/disorders/febrile_seizures/detail_febrile_seizures.htm

The developing immune as well as central nervous systems in young children creates some unique permutations in terms of their response to immune challenges of which we still know very little.

 

[tetano]

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

GPs concerned about flu vaccines

28th April 2010

*
*
*

IPSWICH doctors have voiced concerns that the government's flu immunisation program could be permanently affected.

Ipswich doctors have raised concerns that the public may become scared of being immunised.
Rob Williams

IPSWICH doctors have voiced concerns that the government?s flu immunisation program could be permanently affected.

Ipswich Medical Centre GP Dr Paul Curson said the government?s decision to ban children under five years old from receiving this year?s seasonal flu vaccine, could see a reduced number of vaccinations in the future.

Dr Curson said he was yet to be entirely convinced the death of Brisbane toddler Ashley Esapara, who died the day after she was inoculated earlier this month, was due to her vaccination.

But he said there were fears the controversy could be used as an excuse by some people to not get vaccinated.

?There is obviously a legitimate cause for concern regarding this year?s flu vaccine, and it could lead to people becoming suspicious of vaccines,? Dr Curson said.

?But I still want to know if the vaccine was a coincidence or a cause in the instances of reaction this year.?

An initial Queensland Health autopsy report released late yesterday stated it was unlikely Ashley?s death was due to the vaccination.

Dr Curson said people needed to know that the swine flu vaccination had not caused any problems.

?The swine flu vaccine is thankfully okay, because it will be back this year,? he said.

?Last year my practice saw two middle-aged clients who died because of swine flu.

?The average age of swine flu deaths was 38 last year, which was much lower than the normal flu ? as it generally only has serious effects for people over 70.?

Ipswich and West Moreton Division of General Practice chairperson Dr Lisa Moreton also said flu vaccinations would drop.

?We may see a reduction in uptake of vaccinations following the concerns regarding the more severe reactions we have seen with young children,? she said.

?It should be pointed out that there has been no increased incidence of extreme reactions in children aged over five or adults given the combined seasonal flu vaccine, and that there has been no increased incidence of severe reactions in any age group with the H1N1 swine flu vaccination given alone.?

?We are still strongly recommending the seasonal flu vaccine be given to those aged 65 and over.?

This year?s combined seasonal influenza vaccination contains vaccine against H1N1 swine flu, and two other strains of influenza virus.

?H1N1 swine flu will be the predominant strain of influenza virus again this year in Australia,? Dr Moreton said.

?Parents can still vaccinate their children with Panvax H1N1 swine flu vaccination alone.?

The swine flu vaccination is available free.


http://www.qt.com.au/story/2010/04/28/doctors-fear-effect-of-not-vaccinating/

 

[Ronan Kelly]

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

Hunter toddler recovering from adverse reaction to flu vaccine
28 Apr, 2010 04:00 AM
WITHIN eight hours of receiving the seasonal influenza vaccine toddler Bailey Kirkland was in a critical condition in John Hunter Hospital's emergency department.
His mother Lauren Kirkland said yesterday she had no doubt that her nine-month-old son had suffered an adverse reaction to the vaccine on April 13.

Mrs Kirkland said her son's condition deteriorated within an hour of receiving the vaccine from a GP at noon.

He was admitted to the emergency department at 9.30pm with a fever of 44 degrees (111F) and a heart rate of 220 beats a minute.

Blood and urine tests were unable to provide any clues to the cause of Bailey's condition.

"The doctor said to me they didn't know what caused it and they put it down to a virus," Mrs Kirkland said. "With what's come out recently, I've no doubt now that it was the vaccine."

Mrs Kirkland's three-year-old daughter Sienna, who received the vaccine on the same day, did not suffer any reaction.

Administration of the vaccine was suspended on Friday after dozens of babies and children, mostly in Queensland and Western Australia, were admitted to hospital with high fevers and convulsions.

Hunter New England Health Public Health physician David Durrheim said yesterday it appeared the vaccine may have been linked to Bailey's fever.

"There's not proof that the vaccine caused the fever but the fact that it occurred so quickly means that it is more likely it could have been the vaccine rather than a viral infection," he said.

Dr Durrheim said although vaccines were generally very safe, about one in 10 children would develop a fever.

"It's often an indicator of a good immune response to the vaccine, so generally it's not something to be concerned about," he said.


http://www.theherald.com.au/news/lo...-adverse-reaction-to-flu-vaccine/1814192.aspx

 

[Ronan Kelly]

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

GP reported after toddler death Natasha Bita From: The Australian April 28, 2010 12:00AM
AN Iranian-trained doctor whose two-year-old patient died hours after he gave her a flu shot was reported to Queensland's Medical Board.
The doctor was reported for allegedly failing to notify the death.

Queensland's Chief Medical Officer Jeannette Young yesterday accused the GP of failing to notify Queensland Health of toddler Ashley Jade Epapara's death on April 9, less than 12 hours after her seasonal flu jab.

She said the Medical Board would investigate the doctor for allegedly failing in his legal duty to notify her department of any adverse reactions to vaccinations.

She said Ashley's twin sister, Jaime, had been vomiting, which "possibly" was an adverse reaction to the seasonal flu vaccine that was suspended nationally on Friday.

The Brisbane doctor, Amir Mohammad Eskandari, graduated from a university in Tehran before qualifying to work as a GP in Australia last year, and was granted a "special purpose" registration to work in Queensland in January this year.


Dr Eskandari told reporters yesterday he had not reported the girl's death because it was not clear whether the vaccine had caused it. "We gave swine flu injection and after that nothing happened," he told Network Ten news last night. "They (the twins) were totally fine.

"The other twin, yes, she was a little bit unsettled, a little bit vomiting, but Ashley was fine and they (the family) don't know exactly what's happened."

Dr Young said Queensland doctors had reported 13 "adverse reactions" ranging from fever to vomiting and febrile convulsions among vaccinated children since Friday.

Under fire over her department's almost three-week delay in investigating the girl's death, Dr Young said she had been unable to identify the girl until she was named in weekend media reports.

Dr Young said her staff had called southern Brisbane hospitals, police and the Therapeutic Goods Administration in an effort to confirm the initial April 9 media report, to no avail.

Dr Young admitted she had not called the Queensland Coroner's office, and revealed that her staff had first contacted the grieving family only yesterday. The Coroner's investigation to date had been inconclusive, she said.
http://www.theaustralian.com.au/new...er-toddler-death/story-e6frg6nf-1225859062228

 

[Ronan Kelly]

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

Clues elusive in Australian kids' apparent reactions to flu vaccine
Lisa Schnirring Staff Writer


Apr 27, 2010 (CIDRAP News) ? In the latest developments surrounding suspected adverse reactions to the seasonal flu vaccine in Australian children, an autopsy revealed no clear link to immunization in the death of a 2-year-old, and vaccine maker CSL said it has found no evidence of a bad batch connected to cases reported so far.

The adverse events that the country's health officials are investigating involve CSL's seasonal flu vaccine, which covers the pandemic H1N1 virus. So far most of the reports are concentrated in West Australia state, which unlike other states offers free seasonal flu vaccine for children under age 5.

West Australian officials have received 250 reports of possible adverse reactions, the Australian Associated Press (AAP) reported today. Queensland has also received some adverse-event reports and is investigating the death of a 2-year-old Brisbane girl who died about 12 hours after receiving the vaccine.

The events prompted Australian health officials on Apr 23 to ask health providers to stop giving children under age 5 the vaccine while it investigated fever and convulsions in some children who had received it. At the same time CSL said it stopped shipping the pediatric version of its Fluvax vaccine while it and health authorities investigate the events.

Dr Jeanette Young, Queensland's chief medical officer, said today that the initial autopsy on the Brisbane child revealed no evidence that her death was linked to the seasonal flu shot, but further tests are needed, the Brisbane Times reported today. "It's too early at this stage to say that the vaccine caused this child's death or indeed what did cause this child's death," she said. "But at this stage there's nothing jumping out and saying this child died as a result of receiving the vaccine.''

Meanwhile, CSL, which makes flu vaccine for Australia but is not the country's sole provider, said today that a check of vaccine batch numbers on the adverse-event reports does not indicate that a single batch is responsible for the suspected reactions, the AAP reported today. CSL told the AAP that it was continuing to work with regulators and West Australian health officials to investigate the adverse-reaction reports.

Today South Australia's chief medical officer, Dr Paddy Phillips, said that despite the seasonal flu vaccine ban in children younger than 5, they can still receive the monovalent pandemic H1N1 vaccine, which has not been linked to increased adverse-event reports, the Australian Broadcasting Corp. (ABC) reported today. "Children over the age of five and adults should certainly continue to get the seasonal flu vaccines," he told ABC. "If parents are worried then certainly get the H1N1-specific vaccine. That's been given in millions of doses with no adverse effects including in under five-year-olds."

The adverse event reports have sparked a round of speculation among Australia infectious disease experts, the Sydney Morning Herald reported today. Dr Peter Collignon of Australian National University said children's exposure to the pandemic flu virus last summer might be predisposing them to an aggressive response to a vaccine that contains the strain.

However, Dr Terry Nolan, who was part of a research team that explored children's reactions to the pandemic flu vaccine, countered that Collignon's explanation seemed unlikely, because adverse reactions weren't seen in children who received the second of two recommended pandemic H1N1 vaccine doses last season.

Australia is currently in the midst of its seasonal flu vaccine campaign in advance of the winter flu season, which typically begins in May. Australia has had one wave of pandemic flu, which occurred during its normal flu season last year. Health officials fear Australia and other countries might experience a second pandemic flu wave, especially since the pandemic virus has become the dominant H1N1 strain across the globe.

Last September the World Health Organization (WHO) recommended that the Southern Hemisphere's seasonal flu vaccine cover the pandemic H1N1, a Perth-like strain of influenza A/H3N2, and a Brisbane-like influenza B strain. In February the WHO recommended similar strains for the Northern Hemisphere's next flu season.

See also:

Apr 27 ABC story http://www.abc.net.au/news/stories/2010/04/27/2883310.htm

Apr 27 AAP story http://www.sbs.com.au/news/article/1245346/Flu-vaccine-maker-denies

Apr 27 Brisbane Times story http://www.brisbanetimes.com.au/que...sed-toddlers-death-autopsy-20100427-toz8.html

Apr 28 Sydney Morning Herald story http://www.smh.com.au/national/swine-flu-theory-on-vaccine-reactions-20100427-tq1f.html?

Apr 23 CIDRAP News story "Australia probes seasonal flu vaccine reactions in children" http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/apr2310vaccine.html

http://www.cidrap.umn.edu/cidrap/content/influenza/swineflu/news/apr2710australia.html

 

[Sally Furniss]

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

Thread for the Trivalent vaccine in New Zealand http://www.flutrackers.com/forum/showthread.php?p=353469#post353469

 

[tropical]

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

#33:
"Mrs Kirkland said her son's condition deteriorated within an hour of receiving the vaccine from a GP at noon.

He was admitted to the emergency department at 9.30pm with a fever of 44 degrees (111F) and a heart rate of 220 beats a minute.

Blood and urine tests were unable to provide any clues to the cause of Bailey's condition.
...
dozens of babies and children, mostly in Queensland and Western Australia, were admitted to hospital with high fevers and convulsions."

#35:
""If parents are worried then certainly get the H1N1-specific vaccine. That's been given in millions of doses with no adverse effects including in under five-year-olds.""


severe reaction 1 hour after vaccination
44 degree and heart problems

do we additionaly need a flag wroted "reaction after vaccination"?

the actual human subjection to previous scientificaly proves of "clear link" and "proof" even in a presence of enaugh logical links of more danger,
is depriment

by actual facts, the cojoining of seasonal and 2009 pandemic strains,
represent more dangerous severe reactions than their separate administration,
so if the decisors are enaugh prudent,
that is enaugh to reconsider such policy worldwide
(such policy is also already settled for the North hem.)
__

made finaly, some adjuvants and serious/deadly events free vaccine,
or that's "outher space science"?

 

[german-docter]

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

Emily :tiphat:
Yes, good idea IMO !

H1N1 influenza vaccines reloaded:
Adverse reactions in (young) children are not unusual :

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

Product information November 2009
Fluvax? Junior
For season 2010
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
(?)


http://www.ema.europa.eu/humandocs/PDFs/EPAR/focetria/spc/emea-spc-h710en.pdf
EMEA:ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Focetria suspension for injection in pre-filled syringe
Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Influenza virus surface antigens (haemagglutinin and neuraminidase)* of strain:
A/California/7/2009 (H1N1)v like strain (X-181) 7.5 micrograms** per 0.5 ml dose
* propagated in eggs
** expressed in microgram haemagglutinin.
(?)
4. CLINICAL PARTICULARS
(?)
4.8 Undesirable effects
? Clinical trials
(?)
Children and adolescents 6 months to 17 years of age
Clinical trials with Focetria (H1N1)
(?)
Very common reactions reported in children 12 to 35 months of age:
Tenderness, induration and erythema, irritability, unusual crying, sleepiness, diarrhoea and change in eating
habits.
Fever (≥38?C) has been reported by 14% of subjects 12-35 months old with one subject (1%) reporting fever ≥40?C.


http://www.ema.europa.eu/pdfs/influenza/25590710en.pdf

EMEA: 21 April 2010
EMA/255907/2010
Patient Health Protection
Sixteenth pandemic pharmacovigilance update

This report summarises the adverse drug reactions reported after the use of the centrally authorised pandemic vaccines Arepanrix, Celvapan, Focetria and Pandemrix and the antiviral Tamiflu.
(...)
Arepanrix:
The most frequently reported suspected adverse reactions in children since authorisation included urticaria, angioedema, dyspnoea, anaphylactic reaction, cough, anaphylactic shock, erythema, cyanosis, flushing, hypersensitivity, pyrexia, rash, headache, nausea, pallor, pruritus, skin discolouration, throat tightness and tremor.

Celvapan:
The most frequently reported suspected adverse reactions in children since authorisation included vomiting, hypersensitivity, medication error, syncope, pyrexia, dizziness, nausea, pallor, rash, headache, malaise, vision blurred, fatigue, urticaria, chills, cough, pruritus, dyspnoea, hyperhidrosis and somnolence.

Focetria:
The most frequently reported suspected adverse reactions in children since authorisation included pyrexia, headache, hyperpyrexia, vomiting, cough, nausea, abdominal pain, diarrhoea, injection-site pain, myalgia, fatigue, influenza-like illness, drug exposure during pregnancy, rash, dyspnoea, urticaria, malaise, convulsion and asthma.


Pandemrix:
Updated safety information
The most frequently reported suspected adverse reactions in children since authorisation were pyrexia, hyperpyrexia, vomiting, injection-site pain, headache, diarrhoea, cough, rash, fatigue, decreased appetite, nausea, abdominal pain, malaise, injection-site erythema, crying, somnolence, pallor, listlessness, injection site swelling, syncope, dyspnoea, influenza-like illness, pain in extremity, febrile convulsion, myalgia, urticaria, dizziness, tearfulness and erythema.

Since the last update, four new fatal cases from the EEA have been received by EudraVigilance. They concerned two women aged 70 and 62 years old, one female infant aged one year old and one men aged 62 year old. All patients have medical history which might explain the fatalities. The infant has been reported with septicaemia meningococcal but no details have been reported. ​

 

[tetano]

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

CSL Vaccine Probe Widens in Australia After Seizures (Update2)

By Simeon Bennett

April 28 (Bloomberg) -- Australia?s drug regulator widened an investigation into CSL Ltd.?s seasonal flu vaccine, the first to include the H1N1 pandemic strain, after the shot was linked to fevers and convulsions among children.

The Therapeutic Goods Administration asked the nation?s eight states and territories to examine all reports of fevers among children under 5 years, even cases not directly involving vaccination, for evidence of a pattern that may help explain the incidents, Kay McNiece, a spokeswoman for the regulator, said in a telephone interview from Canberra today.

The regulator said April 23 that children aged 5 and younger should stop receiving CSL?s Fluvax and the company said it stopped distributing the product after complaints of seizures and fevers among children. The reports of possible side effects may deter parents from vaccinating their children even if the shot is shown to be safe, said Alan Hampson, chairman of the Australian Influenza Specialist Group.

?There?ll be collateral damage,? Hampson said by telephone. ?It?s a bit of a disaster not only here, but globally, in casting apparent doubts on the vaccine, which is potentially quite valuable in young children.?

Fifty-five children in Western Australia, 5 years and younger, have been identified with possible convulsions after receiving the shot and a further 196 had less serious reactions such as fever, vomiting and inflammation at the injection site, Western Australia?s health department said. Between 20,000 and 30,000 children in the age group have been vaccinated so far this year, the department estimates.

....


http://www.businessweek.com/news/20...ens-in-australia-after-seizures-update2-.html

 

[Sally Furniss]

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

Higher proportion (relative to other states) of under 5 age group vaccinated

The adverse events that the country's health officials are investigating involve CSL's seasonal flu vaccine, which covers the pandemic H1N1 virus. So far most of the reports are concentrated in West Australia state, which unlike other states offers free seasonal flu vaccine for children under age 5.