Australia. Trivalent flu shots suspended after kids hospitalised, fatality

tetano · Apr 28, 2010

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 · Apr 28, 2010

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 · Apr 28, 2010

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 · Apr 28, 2010

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 ...

:flask:

Giuseppe · Apr 28, 2010

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

[Source: ProMedMail.org, http://www.promedmail.org/pls/otn/f..._BACK_PAGE,F2400_P1001_PUB_MAIL_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/WHO-doubts-dodgy-batch-of-vaccine-caused-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/content/influenza/swineflu/news/apr2310vaccine.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/content/2010/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/ac...stern-australia-spreads-to-more-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><http: 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:>

SusanC · Apr 28, 2010

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

CSL is Australia's only flu vaccine producer, but it is one of several companies that supply seasonal flu vaccine for the Australian market.

I wonder what is their market share in Australia? It's about 7% in the US (according to the above report)

sharon sanders · Apr 28, 2010

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

CSL Vaccine Probe Widens in Australia After Seizures (Update2)

April 28, 2010, 3:56 AM EDT  More From Businessweek




(Adds number of children vaccinated in fifth paragraph.)
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.

snip

CSL, based in Melbourne, has fallen 9.6 percent on the Australian stock exchange since April 23, when the reactions were first reported and the company?s larger competitor, Baxter International Inc., cut its profit forecast. The stock rose 1.8 percent to close at A$33.08, compared with a 1.2 percent decline in the benchmark S&P/ASX 200 Index. ?The vast majority of the share price reaction reflects the concerns raised by Baxter,? said David Low, a health-care analyst at Deutsche Bank AG in Sydney. ?The domestic flu business is relatively small. I would only be concerned if there are implications for the Northern Hemisphere flu market, which we think are unlikely.?

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

Emily · Apr 28, 2010

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

http://www.nzherald.co.nz/health/news/article.cfm?c_id=204&objectid=10641321

Kiwi granddad pays respects to flu girl
By Alanah May Eriksen
4:00 AM Wednesday Apr 28, 2010
A toddler who died in her Australian home a day after having a flu vaccine is a part-Maori girl whose father grew up in Tokoroa.

Two-year-old Ashley Jade Epapara was found dead in her cot on April 9, 12 hours after she and twin sister Jamie received shots at their local GP's office in Mt Gravatt, Brisbane.

A coronial investigation is being made.

The girls' father, David Epapara, 40, moved to Australia in the early 1990s from Tokoroa, where he grew up, to find work as a builder.

He met his Australian wife, Nicole, soon after he arrived.

Speaking last night from his home in Rotoiti, near Rotorua, Bob Epapara, David's father, told the Herald his son had celebrated his 40th birthday with friends and family days before his daughter's death.

Mr Epapara and his partner, Grace, flew to Australia the day after Ashley died for her funeral and to be with the couple, who also have a son Matthew, 6.

The family stayed at Nicole's parents house in the Brisbane suburb of Carindale as the grieving parents did not want to sleep where their baby girl had died, Mr Epapara said.

The house had since been blessed.

Mr Epapara said he accompanied his son and daughter-in-law to the hospital where an autopsy had been carried out.

"The doctors said they couldn't find out what happened. They told us it could be a month before they know. They took lots of samples and that sort of thing and sent them away."

Mr Epapara had never met the twins but had been planning a holiday when Ashley died.

"Jamie knew something was wrong, the other one was gone. She was always calling out her name, she was a real chatterbox."

He had visited his son when he married Nicole in 1996 and a year after Matthew was born.

The little boy still remembered his "Koro", Mr Epapara said.

"We went to the chapel and as soon as we sat down, we were right in the front, he knew what was going on. He started crying. I was hugging him and rubbing his head."

Ashley's body was cremated and her ashes are expected to be put in a wall at the chapel.

tetano · Apr 29, 2010

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

The exposure to last year's swine flu outbreak may have caused children to be more susceptible to experiencing severe reactions that are now manifested through recent influenza vaccinations.

That is one of the theories as to why more than 250 children in WA have been admitted to the hospital for experiencing adverse reactions after being inoculated with the seasonal flu vaccine.

The death of two year-old Ashley Epapara, has also been associated with bad reactions toward the vaccination.

To date, a total of 55 children had been reported to experience febrile convulsions after getting vaccinated while an additional 196 suffered less serious reactions such as fever and vomiting.

According to an infectious diseases expert at the Australian National University, Professor Peter Collignon, a possible theory could be that the children's exposure to swine flu last year could have made their immune system to react aggressively to an injected dose of the vaccine that includes the strain of H1N1.

However, Professor Terry Nolan of the University of Melbourne who conducted the research into children's reactions to swine flu vaccine last year, said the theory seemed unlikely as the children did not exhibit more severe reactions to the second of the two injections given last year.

The deputy director of the National Centre for Immunization Research and Surveillance, Kristine Macartney said more reactions were reported in Western Australia because it was the only state to have a policy of immunizing all children under five with the seasonal flu vaccine.

"Western Australia are immunizing many more young children than other states and territories, where children are only recommended to have the vaccine if they are in a high-risk group," she said.

After receiving immunization, she observed that up to 40 per cent of children will develop elevated temperature and 3 per cent of children will have febrile convulsions at some stage.

Senior research fellow at the centre, Julie Leask, who specializes on social responses to immunization, said it was perfectly understandable that parents and the medical community were worried about the vaccine's undesirable side effects.

http://au.ibtimes.com/contents/20100428/flu-shots-flu-vaccination-wa.htm

tetano · Apr 29, 2010

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

Govt alarmed over flu shot drop
April 29, 2010 - 3:11PM

Queensland Health Minister Paul Lucas is alarmed over a big reported drop in the number of people asking their family doctor to vaccinate them against seasonal and swine flu.

The Australian Medical Association Queensland (AMAQ) fears the flu season could be disastrous with anecdotal evidence from doctors showing there had been a 50 per cent drop in vaccination requests.

Mr Lucas said today that the figure was "extremely concerning".

....

http://www.brisbanetimes.com.au/queensland/govt-alarmed-over-flu-shot-drop-20100429-tuh9.html

Giuseppe · Apr 29, 2010

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

[Source: ProMedMail.org, http://www.promedmail.org/pls/otn/f..._BACK_PAGE,F2400_P1001_PUB_MAIL_ID:1000,82478. Extract, 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">20100429.1383</td></tr><tr><td align="right" nowrap="nowrap">Published Date</td> <td colspan="1" rowspan="1" align="left" nowrap="nowrap">29-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 - NZ, Australia: adverse reactions</td></tr> </tbody></table>
PEDIATRIC INFLUENZA VACCINE - NEW ZEALAND, 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>

Date: Wed 28 Apr 2010
Source: The Sydney Morning Herald, New Zealand Press Association
(NZPA) report [edited]
<http://news.smh.com.au/breaking-news-world/five-nz-kids-react-to-flu-vaccine-20100428-trpw.html>

New Zealand [NZ] children have suffered convulsions from a flu
vaccination following reports of similar reactions in Australia [see:
Pediatric influenza vaccine - Australia: adverse reactions 20100428.1368].

Last week [week of 19 Apr 2010], the NZ Ministry of Health advised
doctors against using Fluvax on children. On Wednesday [28 Apr 2010],
New Zealand's Health Ministry chief adviser for child and youth
health Pat Tuohy told politicians that 5 children had been reported
to have suffered febrile convulsions in New Zealand since Friday [23 Apr 2010].

Australia's chief medical officer had already suspended seasonal flu
vaccinations for children under 5 following concerns stemming from a
significant rise in the number of Australian children developing a
fever after receiving the vaccine. A 2-year-old child was found dead
in her cot on 9 Apr 2010, [one] day after she and her twin sister
were given the seasonal flu vaccination by a private Brisbane GP
[General Practitioner]. The case continues to be investigated.

As of 6 pm (AEST) on Tuesday [27 Apr 2010], Queensland Health had
received 95 notifications of Queenslanders who'd had adverse
reactions after receiving the seasonal flu vaccine. Of those 95
cases, 41 related to children aged 5 and under. And in Western
Australia, flu shots have caused adverse reactions in 251 children under 5.

The NZ Health Ministry was in regular contact with its Australian
counterpart and a teleconference was scheduled to try and garner more
information, he said. On present advice there was no reason for
children, especially those at high risk, to stop receiving other
types of flu vaccines, Dr Tuohy said. Children at a high risk were
considered to be those who had an underlying chronic condition, such
as asthma or diabetes, or those at risk for other reasons including
those from low socio-economic families.

While there had been more reports of severe reactions, including the
5 febrile convulsions, there were also more children receiving the
vaccine and people were more likely to report reactions due to the
media attention.

Australia, New Zealand, and Singapore were the only countries to use
the [Fluvax] vaccine so far this year [2010]. Most northern
hemisphere countries begin flu vaccines in the lead up to winter.
Over 260 000 Fluvax doses were administered in March [2010] and the
ministry said supplies were now likely to be low. More supplies of
[an] alternative vaccine -- Vaxigrip -- were expected from Europe
this week [week of 26 Apr 2010].

--
Communicated by:
Viki Hansen-Landis, MPH, CHES
Senior Medical Communications Specialist
Medical Information and Analysis Team
3600 Horizon Boulevard, Suite 300
Trevose, PA 19053
USA
<Viki.Hansen@internationalsos.com>

[Fluvax, marketed by the CSL company, is a trivalent seasonal flu
vaccine, which includes the pandemic A(H1N1) virus. CSL's Fluvax is
available in adult and pediatric formulations. It 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, the
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.

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. Further
information is awaited. The adverse reactions appear to comprise
predominantly febrile convulsions. The autopsy findings from the
single fatality in Australia were inconclusive and indeed this case
may be unrelated to the subsequent vaccine-related cases, which have
been observed in several Australian states and now in New Zealand. - Mod.CP]

[The HealthMap/ProMED-mail interactive map of New Zealand is
available at <http://healthmap.org/r/00c3>. - Sr.Tech.Ed.MJ]
</pre>(...)
-
-------

tetano · Apr 29, 2010

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

Suspended flu jab caused fits in 67 kids

DOCTORS have reported febrile convulsions in at least 67 young children after the seasonal flu jab, as health authorities scramble to find data on how many Australian children were vaccinated before last week's ban.

State and territory health departments have notified the Therapeutic Goods Administration of at least 410 adverse reactions among children aged five and under to the now-suspended flu shot since its rollout five weeks ago.

They include 67 cases of febrile convulsions -- 55 in Western Australia, where a toddler remains in a serious condition in hospital, three in NSW, one in South Australia and eight in Victoria. In Queensland -- which has referred 77 adverse reactions ranging from febrile convulsions to fever, vomiting, headache and tiredness -- the Coroner is still investigating the death of a two-year-old girl who died within hours of a flu shot.

But health authorities have no idea how many Australian children were injected with the seasonal flu vaccine, a world-first three-in-one combination of swine flu and two other seasonal flu strains, because the vaccination was voluntary.

Start of sidebar. Skip to end of sidebar.

End of sidebar. Return to start of sidebar.

The vaccine is not included on the national Immunisation Register, so the TGA has asked the Pharmacy Board to provide statistics on the number of vaccines sold to date. One of the flu experts who approved the use of the three-in-one vaccine in Australia, Anne Kelso, yesterday said there had been no time to wait for final World Health Organisation advice.

"There was no evidence at that stage to think there would be a safety concern," she said.

"I can't understand how having three strains would cause a problem."

Professor Kelso is director of the WHO Centre for Influenza in Melbourne -- which recommended that the seasonal flu shot cover swine flu for the first time -- and sits on the TGA's Australian Influenza Vaccine Committee, which approved three strains of flu virus in a single vaccine.

The Australian revealed yesterday that the TGA-approved production of the trivalent flu vaccine despite the WHO's decision that it "is not in a position to advise" whether swine flu should be combined with two other seasonal flu strains, or confined to a separate vaccine.

The WHO referred the matter to its Strategic Advisory Group of Experts, which did not clear the three-in-one version until three weeks after Australia's approval.

"It (the TGA) had to do that before SAGE met simply because it takes five months or so for vaccine companies to produce a vaccine," she said. "It had no choice. If we had waited, we wouldn't have had vaccine ready to roll out in time for the flu season this year.

"The TGA saw no reason to be concerned and made an entirely justifiable decision."

http://www.theaustralian.com.au/new...-fits-in-67-kids/story-e6frg8y6-1225860374357

german-docter · Apr 30, 2010

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

New Zealand:

http://www.influenza.org.nz/site_re...Influenza_vaccine_and_febrile_convulsions.pdf

Quote:

Immunization Advisory Center
University of Auckland

Febrile convulsion in young children and the influenza vaccine 2010: Key messages for Health Professionals.

29/4/10

Background
? Fevers are known to occur after flu vaccines, and febrile convulsions are a recognised complication of fever.
? Western Australia has noted a high rate of febrile convulsions reported to their passive reporting system.
o This reporting is unsolicited, passive reporting of events following immunisation therefore it is currently unknown if the febrile convulsions directly attributable to the vaccine or an unrelated febrile illness.

? The vaccine predominantly used in Australia in 2010 has been Fluvax? but other vaccines are used as well.
? It has been proposed that there may be increased reactogenicity with Fluvax? over other vaccines however there is no clinical data to support or refute this.
o While there is no data either way on this ? these influenza vaccines are all very similar in terms of formulation. None of these influenza vaccines contain adjuvant.

? Australia has decided to temporarily suspend its immunisation programme for all children under 5 years of age while they further consider their data.

NZ Situation
? Up until Friday last week (23/4/10) The Centre for Adverse Reaction Monitoring (CARM) had received reports for five febrile convulsions following influenza vaccination? one following Celvapan?, three following Fluvax? and the other unknown.
? CARM does not feel this is an unusual or atypical response rate.
? NZ broadened its subsidised influenza vaccination strategy to more at risk children this year so there are likely to be increased numbers of children immunised.
? With the publicity since the Australia news it is likely that notification rates will increase dramatically. This does not mean there is a new concern ? passive databases always get higher notifications with increased awareness.

Influenza infection in children
? Children are at relatively high risk of influenza: Data for Pandemic H1N1 associated morbidity and mortality last year showed:
o Over 200 hospitalisations.
o Three deaths in children under five years

? This is likely to be a significant underestimate of the burden of disease as many hospitalisation occur as a result of complications from influenza such as pneumonia and therefore are not coded as influenza.
? Risk of severe complications from influenza are particularly high in younger children (under 1 years in particular) and in the identified high risk groups.

Influenza vaccine and fever
? The actual percentage of children who have fever post - influenza vaccine varies between clinical trials. Data indicates that younger children get more reactions (hence the use of the lower dose) and in children under 3 years around a quarter to a third of children may get a fever. As these trials do not include a placebo it is not possible to know which fevers solely attributable to the vaccine and not an inter-current illness.
? Based on World Health Organization recommendations influenza vaccine is not retested every year for reactogencity as it is the same formulation each year with different strain antigens added. There is no reactogenicity data on this year?s trivalent vaccines therefore it is not known if the profile of febrile reactions is higher than normal.
? Monovalent pandemic H1N1 vaccines were used widely in Europe during their influenza season with no reports of increased reactogenicity.

Febrile convulsions/antipyretics
? Approximately 2- 4% of all children have a febrile convulsion at some stage in their life
? Paracetamol or other antipyretics are not effective at reducing febrile convulsions (the convulsion occurs because of the rise in fever, not the actual fever).
? Antipyretics can be used to reduce pain or discomfort, not specifically fever.
? A child who has a febrile convulsion needs to be checked for the underlying cause of fever, do not just assume it is caused by the influenza vaccine. It is important not to miss any underlying important medical issue behind the fever.

General considerations
? Fever is a known side effect of influenza vaccines, particularly in children under 3 years of age.
? It is very difficult to know if there is an increased incidence of fever with this year?s influenza vaccine over previous years at this stage.
? A child at high risk of complications of influenza should still be offered influenza vaccine as the risk of the vaccine is likely to be considerably lower than the risks associated with influenza.
? A child at lower risk of complications of influenza can be considered on a case by case basis, knowing the history of the child, how they respond to illnesses, their likelihood of exposure to influenza etc.
? Children who are due their second dose and have had had a severe febrile reaction to their first influenza vaccine also need to be considered on a case by case basis. For those that are at high risk of complications from influenza it is worth considering administering the second dose, whereas those in lower risk groups may prefer not to go ahead with a second dose: We assume that a vigorous response to the vaccine means a good immune response which therefore suggests the child is likely to have developed protective immunity after a single dose.

This information was current as of 29th April 2010. For updates please refer to:
www.influenza.org.nz
www.immune.org.nz or 0800 IMMUNE (466863)
or your local Immunisation Coordinator or District Immunisation Facilitator.

tetano · Apr 30, 2010

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

Flu vaccine 'reveals no abnormalities'

CRYSTAL JA
April 30, 2010 - 5:54PM

AAP

Authorities are still investigating the flu vaccine scare in Western Australia, with tests so far showing no signs of abnormalities.

Australia's chief medical officer Jim Bishop says there is a possibility a spike in cases of fever and convulsions for young children in WA could simply be linked to the higher number of vaccinations performed in that state.

He's sought to reassure the public once more, following last week's moratorium on seasonal flu vaccinations for children aged under five.

To date there have been 57 cases in WA, compared to six in Victoria, four in NSW and Queensland, two in South Australia and one each in Tasmania and the ACT.

Tests conducted by the manufacturer, the Therapeutic Goods Administration and other independent experts have so far failed to pinpoint a possible cause, Professor Bishop said.

"We don't have evidence at this time that there's any abnormality with the batch or with the vaccine," he told reporters in Canberra on Friday.

But authorities should have a better idea once some of the investigations conclude next week.

Doctors across the states and territories have been asked to trawl through previous records in a search for more cases.

Prof Bishop said some three million doses of the seasonal flu vaccine have gone out this year, with up to two-thirds sent to WA.

It could be a "partial explanation" as to why the western state has experienced a much higher rate of complications, normally expected in one out of every 1000 to 10,000 cases, Prof Bishop said.

WA provides the seasonal flu shot for free to children under five, whereas the rest of the country doesn't.

Each year, CSL's Fluvax vaccine contains fragments of three different types of influenza virus as recommended by the Therapeutic Goods Administration (TGA).

The 2010 version includes the swine flu strain H1N1.

The last paediatric study of Fluvax occurred in 2004-05 but "quality testing" is conducted every year, CSL said.

A trial of the separate swine flu vaccine for children was conducted in 2009.

On Friday morning, Federal Health Minister Nicola Roxon urged the elderly to continue having the seasonal flu shot.

"It's not something that is ordinarily given to young children," Ms Roxon told ABC Television.

"Its major target and the areas the commonwealth funds is for older Australians over 65.

"(There's) absolutely no reports of any concerns there."

http://news.smh.com.au/breaking-new...e-reveals-no-abnormalities-20100430-tz30.html

tropical · Apr 30, 2010

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

http://www.medicalnewstoday.com/articles/187098.php

T Cell Activation With Nanoparticles Studied By U Alberta-Led Team

Main Category: Immune System / Vaccines
Also Included In: Biology / Biochemistry
Article Date: 30 Apr 2010 - 0:00 PDT

___

http://nanocolors.wordpress.com/200...d-influenza-vaccines-including-h1n1-and-h5n1/

Preclinical efficacy of calcium nanoparticles adjuvanted influenza vaccines including H1N1 and H5N1

Posted on August 24, 2009 by nanocolors

Tonka · May 1, 2010

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

http://www.theage.com.au/national/childrens-vaccine-fits-remain-mystery-20100430-tzgm.html

Children's vaccine fits remain mystery

MARK METHERELL AND AMY CORDEROY
May 1, 2010

AFTER a week of analysis, medical authorities are still at a loss to explain why 57 children have had convulsions after receiving influenza vaccine.

The Commonwealth's chief medical officer, Jim Bishop, yesterday announced that a national ban on administering the mixed seasonal and swine flu vaccine to children aged five and under would continue.

Professor Bishop said no evidence had been found of a suspect batch of the CSL vaccine going to Western Australia, where there have been 57 cases of convulsions in children aged five or under.

Advertisement: Story continues belowAlthough dramatically disproportionate to the rest of Australia's 20 cases of convulsions, including six in Victoria and four in New South Wales, the WA numbers may be partly explained by its higher vaccination rates because the vaccine is available free to infants. Typically the rate of fever with convulsions after vaccination was between one in a 1000 and one in 10,000.

Meanwhile, tens of thousands of Australians have been unable to get flu shots due to a shortage of seasonal flu vaccine.

There had been unprecedented demand this year, said Greg Caleo, managing director of Calastica, a workplace health provider. His company had to cancel 30,000 injections this month.

While the vaccine's increased popularity may be partly to blame, there have been problems getting supplies into the country.

Alan Hampson, chairman of the Influenza Specialist Group in Australia, said: ''It does seem as if there is a higher patient awareness of influenza at the moment and that is a good thing.''

He advised young, healthy people anxious to get the flu vaccine to consider having the swine flu vaccine.

Ronan Kelly · May 1, 2010

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

Residue in flu jab causing kids' reactions: scientist GRAEME O'NEILL
May 2, 2010

A LEADING researcher claims to have identified why the seasonal flu vaccine is causing an outbreak of adverse reactions in children, including high temperatures, fits and convulsions.

Professor Nikolai Petrovsky, a Flinders University immunologist, says an experiment he carried out indicates that large amounts of viral genetic residue created by the vaccine's manufacture were overloading infants' immune systems.

The experiment left him in "absolutely no doubt" that high levels of the residue in the form of RNA (the viruses' genetic blueprint) were the cause.
Professor Petrovsky's claims were supported by Melbourne immunologist Professor Bryan Williams, whose team at the Monash Institute of Medical Research is at the forefront of research into how the immune system detects infection.

"I was planning to design my own experiment to test this, before I heard about Professor Petrovsky's result," he said.

This year's vaccine contains more RNA than previous years, because it consists of several inactivated seasonal strains of influenza virus combined with the pandemic H1N1 swine flu strain. Professor Petrovsky says RNA extracted from the flu vaccine triggered an "enormous reaction" in human immune-system cells in vitro.

Professor Petrovsky is founder and chief executive of Vaccine Limited, which has developed a system for producing vaccines in genetically modified insect cells without using viruses themselves.

The method does not produce genetic residue.

Professor Petrovsky said it was ''amazing that the regulatory system still doesn't require manufacturers like CSL to measure the amount of contaminating RNA, despite 50 years of data showing that RNA levels can vary greatly from vaccine to vaccine''.

''It's a nonsensical way to make a reliable product for human medical use,'' he said.

A CSL spokesman declined to respond.

Five years ago Carol Sledz, a graduate researcher in Professor Williams' research group, published a paper in Nature Cell Biology reporting that short RNA molecules could trigger the innate immune response in mammals.

When the RNA molecules activate the receptors, the cells produce interferons, which cause a protective fever and an elevated temperature that helps to destroy viruses and TNF-alpha, which drives a cascade of inflammatory reactions.

These are the symptoms seen in the children who have suffered adverse reactions to the seasonal flu vaccine. In the early years, fever and high temperatures can cause mental confusion and convulsions.

Professor Petrovsky says RNA-digesting enzymes degrade RNA residues in some flu vaccines, but CSL's vaccines consistently rank near the highest for RNA.

http://www.theage.com.au/national/r...g-kids-reactions-scientist-20100501-u0dd.html

Ronan Kelly · May 1, 2010

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

from an earlier article;

-snip-
Professor Nikolai Petrovsky is the director of Vaxine, based at Flinders University, and the developer of a rival vaccine.
He says there have definitely been adverse reactions in SA, and warns that swine flu vaccinations are not free from reactions either.

He wants an inquiry into the relationship between the Federal Government and CSL, which he says is driving the ongoing use of "old" technology.

"They're trying to convince you it's perfectly reasonable to stick with a 50-year-old vaccine technology despite massive advances in the technology in the meantime which make it more effective, safer, more reliable," he said.
-snip-
http://www.heraldsun.com.au/news/br...e-to-be-released/story-e6frf7jx-1225860680638

german-docter · May 3, 2010

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

Contrast:

Influenza Vaccines: Pre-approval studies for use in children aged 6 months to 3 years

Focetria ? (H1N1 with adjuvant MF 59; manufacturer: Novartis, Europe)

versus

Fluvax ? junior (trivalent, without adjuvant, manufacturer: CSL Limited, Australia)

Fever (≥38?C) as a systemic adverse event:

Focetria ? (H1N1, adjuvanted): 14 %

Fluvax ? junior (trivalent, including H1N1; not adjuvanted): 22.5 %

sources:

http://www.ema.europa.eu/humandocs/PDFs/EPAR/focetria/spc/emea-spc-h710en.pdf

Focetria? (Novartis)

Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted)
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
(?)
Adjuvant MF59C.1 containing:
squalene 9.75 milligrams
(?)
? Clinical trials
(?)
Children and adolescents 6 months to 17 years of age
Clinical trials with Focetria (H1N1)
(?)

Data from 81 children 12-35 months old receiving the 7.5 μg formulation, showed that during the week following the first vaccination 68% of subjects reported at least one adverse reaction of any type, 49% of the subjects reported local reactions at the injection site, and 53% of the subjects reported systemic reactions.

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

Product Information
Fluvax? Junior vaccine 2010 (AUST R 149127)
0.25 mL and 10 x 0.25 mL presentations
November 2009
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
(?)
ADVERSE EFFECTS
Clinical trials:
Paediatric study (CSLCT-FLU-04-05)
The safety, tolerability and immunogenicity of Fluvax? vaccine in a paediatric population (≥ 6 months to < 3 years (?)

Table 1: Proportion of Paediatric Subjects with Solicited Local and Systemic Adverse Events within 7 days of Administration of Fluvax? vaccine

Group A (n = 151)
(≥ 6 months to < 3 years)
SolicitedAdverse Event
Systemic

Fever* 22.5 %

* Axillary Temperature ≥ 37.5?C or Oral Temperature ≥ 38.0?C

SusanC · May 3, 2010

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

This debate is now getting more and more interesting. Or maybe it's just my ignorance.

em

Even though Petrovsky has an obvious interest in making derogatory comments about a rival vaccine, I took a brief look at the science he referred to, which is basically that too much small fragments of RNA (ie outside of the measured antigen content) can trigger the innate immune response in powerful ways. Here's the paper he referred to, which of course is only the starting place for anyone interested in pursuing the question. Sledz 2003 Activation of the interferon system by short-interfering RNAs This paper has been cited an impressive 933 times, which doesn't prove anything, but is a good place to start looking IMO. For anyone looking, that is...

Australia. Trivalent flu shots suspended after kids hospitalised, fatality

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