Australia. Trivalent flu shots suspended after kids hospitalised, fatality

[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/f...e_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/local/news/general/hunter-toddler-recovering-from-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/news/nation/gp-reported-after-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/2...27/2883310.htm

Apr 27 AAP story http://www.sbs.com.au/news/article/1...e-maker-denies

Apr 27 Brisbane Times story http://www.brisbanetimes.com.au/quee...0427-toz8.html

Apr 28 Sydney Morning Herald story http://www.smh.com.au/national/swine...427-tq1f.html?

Apr 23 CIDRAP News story "Australia probes seasonal flu vaccine reactions in children" http://www.cidrap.umn.edu/cidrap/con...10vaccine.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/sho...469#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
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/2010-04-28/csl-vaccine-probe-widens-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.

[tetano]

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

Government 'too cosy with flu vaccine maker'


The Federal Government has been accused of making flawed decisions because of its overly "cosy" relationship with flu vaccine manufacturer CSL.

Health officials are investigating the death of a two-year-old Brisbane girl and more than 250 reports of adverse reactions among children who have received the seasonal flu vaccine, and Australia's chief medical officer has issued a warning to doctors to stop using the CSL shots on the under-fives.

Now the vaccine manufacturer is facing claims it has undue influence over the Federal Government and that this "close relationship" has blocked the rollout and funding of more advanced flu vaccines on the Australian market.

Professor Nikolai Petrovsky from Flinders University is also the research director of rival vaccine manufacturer, Vaxine. He is calling for an independent inquiry into the Federal Government's relationship with CSL.

http://www.abc.net.au/news/stories/2010/04/28/2884576.htm

[tetano]

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

THE World Health Organisation initially baulked at approving the three-in-one flu shot rubber-stamped by Australian authorities last year.

The Therapeutic Goods Administration cited WHO advice when it approved the seasonal flu vaccine that was suspended last Friday after a spike in the numbers of children suffering high fevers and febrile convulsions after vaccination.

But the WHO recommendation, accessed via a link on the TGA website, reveals it had yet to decide whether the H1N1 swine flu strain should be mixed with two seasonal flu strains in a one-shot vaccine to cover all three types of flu.

"At this time, WHO is not in a position to advise whether there should be one trivalent influenza vaccine containing all three viruses, or whether there should be separate vaccines for pandemic and seasonal influenza," the WHO advice, dated September 23 last year, states.

Start of sidebar. Skip to end of sidebar.

End of sidebar. Return to start of sidebar.

"WHO will be in a position to provide guidance on this issue after the Strategic Advisory Group of Experts meets in late October and deliberates on this issue."

The TGA's Australian Influenza Advisory Committee met on October 2 - three weeks before the SAGE deliberations in Switzerland - and approved the world-first three-in-one combination now suspended for use in children aged five and under.

SAGE eventually approved the use of either a three-in-one shot, or separate injections of the swine flu vaccine and a two-in-one seasonal flu shot, "subject to national needs".

It said southern hemisphere countries that chose the trivalent vaccine - such as Australia - should be "encouraged" to donate any surplus swine flu vaccine to the WHO.

SAGE also noted that "little immunogenicity data are currently available" for swine flu vaccines used in children aged from six months to 10 years.

"SAGE recognises there is no indication at this stage that unusual adverse reactions are being observed," it said in a summary of its October meeting.

"In spite of these preliminary reassuring results, continued vigilance and regular evaluation by health authorities are needed."

Australian authorities are urgently investigating side effects, including febrile convulsions and fever, in more than 200 children since the three-in-one flu shot was rolled out five weeks ago.

A Perth toddler who received the vaccine is in intensive care, and Queensland's Coroner is investigating the death of a two-year-old girl who died hours after her seasonal flu shot on April 8.

The federal Health Department's Technical Advisory Group on Immunisation, which is spearheading the investigation, said yesterday it still had no idea whether the number of adverse reactions was abnormal.

TAGI chairman Terry Nolan revealed last night the Australian Childhood Immunisation Register did not appear to be up to date. "We still have concerns about the accuracy of the data," Professor Nolan said.

He said there was "no reason to think" the fevers were being triggered by the first-time inclusion of the swine flu strain in the seasonal jab.

"The rest of the world is very interested in whether or not there is something going on here," Professor Nolan added.

http://www.theaustralian.com.au/news/nation/who-dubious-about-flu-jab/story-e6frg6nf-1225859625932

[german-docter]

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

Quote:

http://www.who.int/csr/disease/swineflu/meetings/sage_oct_2009/en/

WHO:

4 December 2009
Pandemic influenza A (H1N1) 2009 virus vaccine ? conclusions and recommendations from the October 2009 meeting of the immunization Strategic Advisory Group of Experts
(?)

SAGE reviewed the options for southern hemisphere seasonal influenza vaccine formulations for use in 2010. These include a trivalent vaccine (strains of A (H1N1) 2009; A (H3N2); and B) or, alternatively, a bivalent vaccine (strains of A (H3N2) and B) and a separate monovalent pandemic (H1N1) 2009 vaccine.

SAGE recognized the increased programmatic complexities associated with the use of 2 separate products (bivalent and monovalent influenza vaccines) rather than of a trivalent product. However, SAGE also recognized that the bivalent + monovalent option was being requested by certain southern hemisphere countries, and that this option had the advantage of increasing availability of pandemic (H1N1) 2009 vaccine since it would allow increased quantities of adjuvanted influenza A (H1N1) 2009 vaccine to be produced compared with production of unadjuvanted vaccine, thereby maximizing the availability of pandemic vaccine.

SAGE concluded that both the trivalent and the bivalent + monovalent options should be available for formulation for 2010 southern hemisphere seasonal influenza vaccine production, subject to national needs. SAGE encouraged southern hemisphere countries that choose to use trivalent vaccine to donate any surplus monovalent A (H1N1) 2009 vaccine supplies to the WHO initiative.

[tropical]

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

#42:
" He said there was "no reason to think" the fevers were being triggered by the first-time inclusion of the swine flu strain in the seasonal jab."


the triggers were the seasonal strains only ...

[Giuseppe]

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

[Source: ProMedMail.org, http://www.promedmail.org/pls/otn/f?..._ID:1000,82460. Edited.]

<table id="apex_layout_271110100662109808" class="formlayout" summary=""><tbody><tr><td align="right" nowrap="nowrap">Archive Number</td> <td colspan="1" rowspan="1" align="left" nowrap="nowrap">20100428.1368</td></tr><tr><td align="right" nowrap="nowrap">Published Date</td> <td colspan="1" rowspan="1" align="left" nowrap="nowrap">28-APR-2010</td></tr><tr><td align="right" nowrap="nowrap">Subject</td> <td colspan="1" rowspan="1" align="left" nowrap="nowrap">PRO/EDR> Pediatric influenza vaccine - Australia: adverse reactions</td></tr> </tbody></table>
PEDIATRIC INFLUENZA VACCINE - AUSTRALIA: ADVERSE REACTIONS
************************************************** ********
A ProMED-mail post
<http://www.promedmail.org>
ProMED-mail is a program of the
International Society for Infectious Diseases
<http://www.isid.org>

[1]
Date: Tue 27 Apr 2010
Source: Medical Search, Australian Associated Press (AAP) report [edited]
<http://www.medicalsearch.com.au/News...problems-44270>


A World Health Organisation influenza expert says it's unlikely that
a dodgy batch of seasonal flu vaccine is responsible for bad
reactions in children. Dozens of babies and young children, mostly in
Western Australia and Queensland, have suffered adverse reactions
after having the flu shot, including fevers and convulsions. And the
Queensland Coroner is investigating the death of a 2-year-old
Brisbane girl, found dead in her cot a day after she and her twin
sister were vaccinated. Seasonal flu shots for children under 5 have
been suspended since Friday [23 Apr 2010].

Ian Barr, the deputy director of the World Health Organisation
influenza centre in Melbourne, told the ABC [Australian Broadcasting
Corporation] 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."

Australia's chief medical officer professor Jim Bishop has ordered a
review of hospitals records to better understand the scope of the
problem. He's also urged medical staff and parents to immediately
report any adverse reactions among children.

--
Communicated by:
Ian Carter
Chairperson
South Eastern Area Laboratory Services
Microbiology Department
Kogarah Sydney
<Ian.Carter@sesiahs.health.nsw.gov.au>

******
[2]
Date: Fri 23 Apr 2010
Source: CIDRAP (Center for Infectious Disease Research & Policy) News [edited]
<http://www.cidrap.umn.edu/cidrap/con...10vaccine.html>


Australia probes seasonal flu vaccine reactions in children
-------------------------------------------------------------------------
Australia's chief medical officer asked providers to stop giving
children under age 5 the seasonal flu vaccine made by CSL Ltd after
receiving reports of fever and convulsions in kids in Western
Australia who had recently been immunized. The country's drug
regulatory agency, the Therapeutic Good Administration (TGA), is
investigating the reports and will test samples of the vaccine that
CSL has agreed to provide, Bloomberg News reported today [23 Apr 2010].

CSL, an Australia-based flu vaccine producer, said in a statement
today [23 Apr 2010] it was urgently investigating the reports along
with federal and state health officials and that it has stopped
distributing its pediatric vaccine to reduce the risk of inadvertent
administration to children younger than 5. CSL is Australia's only
flu vaccine producer, but it is one of several companies that supply
seasonal flu vaccine for the Australian market. CSL's trivalent
seasonal flu vaccine covers 3 flu strains, including pandemic H1N1.

Over the past month, 22 children from the state [Western Australia]
were hospitalized after experiencing febrile convulsions within 12
hours of receiving the vaccine, The West Australian reported today
[23 Apr 2010]. Health officials added that one child became seriously
ill, and it was still unclear if the vaccine was the cause of the
children's symptoms.

Children ages 6 months to 5 years old in Western Australia [WA] are
eligible to receive free seasonal flu vaccination, and the pattern
and rate of adverse events has not been seen in any of the country's
other states, the TGA said in a press release today [23 Apr 2010].
"TGA will test batches of the vaccine used in WA for any
abnormalities," the agency said, adding that other Australian states
and territories are focusing their immunization efforts on high-risk
groups. The TGA also said it would explore if the reactions reported
in Western Australia relate to the vaccine or the state's vaccine
delivery system. Today's [23 Apr 2010] warning does not apply to
CSL's single-strain (monovalent) pandemic H1N1 vaccine.

The problem with CSL's vaccine comes as vaccination efforts are
ramping up across Australia and other parts of the Southern
Hemisphere where flu season typically begins sometime in May. Health
officials in Australia have warned that the season could see the
nation's 2nd wave of pandemic [A(H1N1)] flu. Demand for the vaccine
has been fairly strong, and some parts of the country have reported
vaccine shortages, according to media reports.

CSL's Fluvax, available in adult and pediatric formulations, is an
inactivated split-virus vaccine that does not include an adjuvant. It
contains the flu strains recommended by the World Health Organization
(WHO) for the Southern Hemisphere's seasonal flu vaccine: that is,
pandemic A(H1N1), an influenza A Perth-like H3N2, and a Brisbane-like
influenza B. In February [2010] the WHO recommended similar strains
for the Northern Hemisphere's next flu season.

The company's Afluria was one of 6 seasonal flu vaccines that were
approved for use during the United States' current flu season, and
CSL is one of the companies providing pandemic flu vaccine to the
country. According to background from the Health Industry
Distributors Association (HIDA), CSL vaccine accounted for an
estimated 8 million doses, or about 7 percent of the nearly 115
million seasonal flu vaccine doses that were projected to be
available this season.

In November [2009] the US Food and Drug Administration (FDA), under
an accelerated process, expanded its approval of CSL's seasonal and
pandemic vaccine for infants and children ages 6 months and older.

[Byline: Lisa Schnirring]

--
Communicated by:
ProMED-mail
<promed@promedmail.org>

******
[3]
Date: Tue 27 Apr 2010
Source: ABC News (Australian Broadcasting Corporation), The World
Today [abbreviated & edited]
<http://www.abc.net.au/worldtoday/con...0/s2883650.htm>


Australia's chief medical officer Jim Bishop has asked health
authorities in each state and territory to assemble a picture of how
many children under 5 have suffered adverse reactions after being
vaccinated against the flu and the numbers have begun to come in.

In Western Australia, health authorities have recorded 251 cases. 15
cases have been recorded in Queensland. The Northern Territory has
acknowledged 3. There have been 2 in Tasmania. South Australia
reported 1 case last week and Victoria's Health Department says there
have been just a handful of cases there.

Health officials in the ACT [Australian Capital Territory] and New
South Wales won't release their figures yet.

[Byline: Ashley Hall]

--
Communicated by:
ProMED-mail
<promed@promedmail.org>

******
[4]
Date: Tue 27 Apr 2010
Source: Easybourse, Dow Jones report [abbreviated & edited]
<http://www.easybourse.com/bourse/act...-than-250-infa>


A health scare that has embroiled biopharmaceutical company CSL Ltd.
(CSL.AU) spread further Tuesday [27 Apr 2010], when authorities in
Western Australia [WA] state said more than 250 infants had fallen
ill after receiving seasonal influenza vaccines.

The WA Health Department said 55 children in the state had suffered
possible febrile seizures after being vaccinated, while another 196
suffered less severe reactions such as fevers and vomiting.

There is also a report that the coroner in Queensland state was
investigating the death of a 2-year-old girl who died shortly after
being vaccinated.

CSL suspended distribution of its paediatric seasonal influenza
vaccine in Australia on Friday [23 Apr 2010] as authorities halted
influenza vaccinations for children aged under 5. A WA health
Department spokeswoman said the state's influenza vaccines were
supplied by CSL and 2 other manufacturers, Solvay SA (SOLB.BT) and
Sanofi-Pasteur SA (AVP.YY). CSL, which said Friday [23 Apr 2010] that
it was cooperating with an Australian government investigation into
the problem, was unavailable for comment.

Brisbane's Courier-Mail newspaper reported that a child was found
dead at her home in the Queensland state capital on 9 Apr 2010, 12
hours after receiving the influenza vaccine. It said an autopsy had
failed to identify a cause of death and the state's coroner was
conducting tests to check whether the fatality was linked to the vaccine.

CSL said last week [week of 19 Apr 2010] that its seasonal vaccine
immunized children against 3 influenza strains, including the
pandemic H1N1, also known as swine flu.

[Byline: Neil Sands]

--
Communicated by:
ProMED-mail
<promed@promedmail.org>

[The pediatric vaccine contains the influenza virus strains
recommended by the World Health Organization for the Southern
Hemisphere's seasonal flu vaccine: that is, the pandemic A(H1N1)
virus, an influenza A Perth-like H3N2, and a Brisbane-like influenza
B. (In February 2010 the WHO recommended similar strains for the
Northern Hemisphere's next flu season). It is unclear at present to
what extent the adverse reactions are related to an individual
component of the vaccine, or the whole CSL vaccine, or one or more
production batches of the vaccine. An autopsy of a deceased child has
failed to identify a cause of death or indeed whether the death was
linked to the suspect vaccine. Further information is awaited.

In Western Australia where the problem was first recognised, there
have been 251 cases. Now 15 cases have been recorded in Queensland,
and the Northern Territory has acknowledged another 3. There have
been 2 cases in Tasmania, 1 in South Australia and a "handful" in Victoria.

The HealthMap/ProMED-mail interactive map of Australia can be
accessed at <http://healthmap.org/r/01eA>. - Mod.CP]
</pre><http: www.promedmail.org=""><http: www.isid.org=""><http: www.medicalsearch.com.au="" news="" who-doubts-dodgy-batch-of-vaccine-caused-problems-44270=""><ian.carter@sesiahs.health.nsw.gov.au><ht tp: www.cidrap.umn.edu="" cidrap="" content="" influenza="" swineflu="" news="" apr2310vaccine.html=""><http: www.abc.net.au="" worldtoday="" content="" 2010="" s2883650.htm=""><http: www.easybourse.com="" bourse="" actualite="" news="" 822684="" vaccine-scare-in-western-australia-spreads-to-more-than-250-infa=""><http: healthmap.org="" r="" 01ea=""></http:></http:></http:></http:></ian.carter@sesiahs.health.nsw.gov.au></http:></http:></http:>