Doctors Advised to Avoid One Flu Shot Brand for Young Kids

A government advisory panel is recommending that doctors avoid giving one brand of flu vaccine to young children this year after children in Australia and New Zealand who got the shot suffered from convulsions and fever. The vaccine at issue is one made by CSL Biotheraphies, an Australian company.

http://www.clevelandleader.com/node/14322

CSL Biotheraphies is one of five manufacturers supplying the United States this fall, but accounts for only a small portion of the 170 million doses. They will be providing just 10.5 million doses.

The Advisory Committee on Immunization Practices said on Thursday that doctors should not give the CSL vaccine to children aged 6 months through 8 years. They were concerned about the unexplained higher rate of fevers and seizures seen in young children who got the vaccine earlier this year in New Zealand and Australia. For children under 5, the rates were 10 times that of other flu vaccines. No deaths were linked to the problem.

The Committee provides vaccine advice to the Centers for Disease Control and Prevention, which typically adopts its recommendations and sends that advice to doctors and the general public.

Investigators in Australia have not been able to find anything in the CSL vaccine that would explain why it would cause more fevers and convulsions in children.

OH boy here we go again folks....prepare yourselves for the "Everybody Needs to be Vaccinated" propaganda media campaign to fire up again..........if it wasn't bad enough to have such a high rate of seizures in children,I have found another article which shows our very own vile gangster government is go so far as to change the labeling on a vaccine made by Australia's CSL Ltd (CSL.AX) because it appears to have caused a higher than usual rate of seizures in children.........So knowing this the GOVT, our Govt's, solution is not to recall the vacine for futher testing or to block its import, heck no, instead it's to change the labels on the bottles without the public's knowledge.....I mean what the hell we are just cattle right? Read on and you'll see what I mean...............

Companies start shipping U.S. flu vaccines

Fri Jul 30, 2010 4:43pm EDT

* 170 million vaccines expected for U.S. market

* Universal vaccination now recommended (no surprise there, during their last vaccination, swine flu propaganda scare program last year, More than 43 percent of the supply for the U.S. public had gone to waste.....Oh course they want to force us to take the shot, just like health care, cap and trade and illegal immigrants)
http://www.reuters.com/article/idUSN3019609820100730

WASHINGTON, July 30 (Reuters) - Two flu vaccine makers said on Friday they had started shipping supplies for the U.S. market, one of the earliest starts ever to distributing seasonal influenza vaccine.

And U.S. officials said they were changing the labeling on a vaccine made by Australia's CSL Ltd (CSL.AX) because it appears to have caused a higher than usual rate of seizures in children.

Sanofi Aventis (SASY.PA) said it was shipping 70 million doses of seasonal flu vaccine -- its largest production run ever -- and GlaxoSmithKline (GSK.L) said it was shipping 30 million doses of partner ID Biomedical's FluLaval vaccine.

"This year we also are launching Fluzone High-Dose (Influenza Virus Vaccine) for people 65 years of age and older," Sanofi said in a statement.

Tests have shown that people over 65 produce a weaker immune response but get better protection when immunized with a stronger vaccine.

Glaxo said it would begin shipping its own flu vaccine, Fluarix, within a few weeks. Other vaccine makers for the U.S. market include Novartis (NOVN.VX) and AstraZeneca (AZN.L) (AZN.N) unit Medimmune.

BROAD RECOMMENDATION

The U.S. Centers for Disease Control and Prevention recommends that everyone be vaccinated against seasonal flu this year, the most universal recommendation yet for flu vaccines. The CDC says manufacturers have forecast they will have 170 million doses of flu vaccine for the 2010-2011 U.S. flu season.

Last year the U.S. government shipped 162 million doses of H1N1 vaccine but only 90 million were used. About 40 percent of Americans in the groups advised to be vaccinated ever go get immunized.

Most years, seasonal influenza infects between 5 percent and 20 percent of the U.S. population and kills 36,000 people. It puts about 200,000 into the hospital.

But last year the new pandemic of H1N1 swine flu replaced virtually all other flu strains. It was about as deadly as seasonal flu but instead of hitting the elderly, the most severely ill were younger adults, children and pregnant women.

The 2010-2011 seasonal flu vaccine will include the H1N1 swine flu vaccine, plus the most common strains of H3N2 and influenza B.

FOCUS ON AFLURIA

"The labeling for one vaccine, CSL Limited's Afluria, has undergone changes this season to inform health care providers about an increased incidence of fever and febrile seizure, which was seen in young children, mainly those younger than 5 years, following administration of the 2010 Southern Hemisphere formulation of CSL's influenza vaccine," the U.S. Food and Drug Administration said in a statement.

"CSL Limited will not be supplying the United States with the 0.25 milliliter single-dose, prefilled syringes, which are used in very young children."

The FDA said it was asking CSL to conduct a study of its vaccine in children.

Flu vaccines have to be made fresh every year to match the circulating strains of the virus. They are made using old technology involving chicken eggs, and manufacturers cannot always predict how much vaccine they will be able to produce and when.

A few companies can now make vaccine in cells and governments are working with industry to switch over to faster and more predictable ways to make flu vaccines.

CLICK HERE TO GO BACK TO MAIN PAGE................or HERE TO GO HOME

HEALTH ALERT: H1N1 Vaccine Included In 2010 – 2011 Seasonal Flu Vaccine

The damn Swine Flu Vaccine Rears it's ugly head again!.......Lets not forget that they bought far more than was needed or used during their last faux pandemic.....look forward to seeing a more aggressive flu campaign in the upcoming months!

CLICK HERE TO GO BACK TO MAIN PAGE................or HERE TO GO HOME

Flu vaccination ban goes national after fever, convulsions in children

"He couldn't cry - his head was hanging down in the car seat and he couldn't move. I was petrified - it was one of the worst experiences of my life."




Seasonal flu vaccinations across Australia for children under five have been suspended after 23 children in Western Australia were admitted to hospital with convulsions following their injections.

http://www.watoday.com.au/wa-news/flu-vaccination-ban-goes-national-after-fever-convulsions-in-children-20100423-tglp.html

One child, aged 1, remains in a coma in a Perth hospital.

Commonwealth chief health officer Professor Jim Bishop yesterday announced the suspension while authorities urgently review data from around the country.

WA's chief public health officer Tarun Weeramanthri has defended the response time in closing down the state's juvenile flu vaccine program amid revelations that children were presenting with convulsions more than two weeks ago.

* Rogue batch may be to blame
* National warning to GPs
* Perth mum: 'I was petrified'
* WA free vaccine program suspended


More than 60 children around the state may have had adverse reactions to the vaccine, including fevers, vomiting and febrile convulsions - a type of fit brought on by a high fever.

One child remains in a critical condition in hospital after being given the vaccine. Dr Weeramanthri said he had few details on the child's condition but they were "seriously ill".

He said a national process set by the Therapeutic Goods Administration had been observed in responding to the reactions. Under the process the best clinical information was collected from as many doctors as possible and an assessment made on the "totality of that".

"We take all reports very seriously and we believe we've acted in a very timely fashion," Dr Weeramanthri said.

"We've been monitoring the situation, we've been talking to clinicians and we've acted as soon as we can."

He said that since this year's vaccine program started a month ago, 23 children under the age of 10 had presented to Princess Margaret Hospital with convulsions related to vaccinations they had received less than 12 hours before.

Another 40 convulsion cases had been detected in the past month in children at other metropolitan hospitals and in Bunbury. Doctors are now working to determine how many of those children received the flu vaccine.

Aside from the convulsions, affected children were suffering fever and vomiting within 12 hours of their flu shots.

A teleconference today with state, territory and TGA officials confirmed the picture in other states would not be available for "a few days".

Dr Weeramanthri said the TGA was assessing the geographical spread of symptoms across Australia, and directly testing batches of vaccine for any impurity.

Rogue batch may be to blame

Health authorities are also working to determine if the entire Fluvax drug, or just batches, have caused the symptoms, and whether an alternative vaccine should be used.

University of Western Australia school of Paediatrics and Child Health Associate Professor Peter Richmond said that only Fluvax - produced by Australia's biggest biopharmaceutical company CSL - was being used to vaccinate children in WA.

Dr Richmond said researchers were trying to determine whether it was the entire vaccine, or just batches, that had caused the problems which today prompted Australia's chief medical officer to tell doctors to stop giving the vaccine to children.

He said the side effects had been largely limited to children under the age of five and he would not recommend that anybody in other groups - including elderly people - cancel their flu shots.

"This is not a long-term safety issue with vaccines," Dr Richmond told WAtoday.com.au.

He recommended parents of young children who had received only the first of the required two vaccination doses hold off on the second dose for now.

This was despite the fact children who had no side effects from their first dose were unlikely to receive complications from their second.

Dr Richmond said the first dose provided partial protection against the flu anyway.

He said researchers were examining whether an alternative drug to Fluvax could be used for the second dose - generally scheduled for four weeks after the first.

Researchers were also trying to determine if the problem with Fluvax was temporary only - and whether the drug could still be used in coming weeks for the second dose.

He stressed that the vast majority of children receiving Fluvax had suffered no complications.

National warning to GPs

Commonwealth chief medical officer Jim Bishop issued a national warning to GPs not to use the vaccine followed a decision last night by the WA government to suspend the free vaccination program for children under five over concerns it was causing high fevers and convulsions.

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

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

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

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

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

He said there did not appear to be any side effects from the swine flu vaccine Panvax.

"It is safe to have the swine flu vaccine," Professor Bishop said.

"The TGA's assessment of clinical trials and the advice of its expert committees is that Panvax is a safe, effective vaccine for prevention of the H1N1 influenza.

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

'I was petrified'

Perth mother of two Bea Flint said her 11-month-old boy Avery had a seizure after receiving the first dose of the two-dose flu vaccination on Saturday.

Mrs Flint said that after the 9am vaccination she noticed Avery had a minor temperature about 2pm. She treated him with Panadol and by Avery's 7pm bedtime he seemed "OK".

However, at 7.45pm, Avery started whimpering and moaning.

When Mrs Flint got to his cot the baby had vomited and was lying on his side having a seizure.

"In the car driving to the hospital he was just whimpering," she said.

"He couldn't cry - his head was hanging down in the car seat and he couldn't move.

"I was petrified - it was one of the worst experiences of my life."

By the time Avery arrived at St John of God Hospital in Murdoch, he was burning up with a fever of 39.5 degrees.

The doctor who treated Avery told Mrs Flint her baby was the fifth child with similar symptoms admitted to the hospital that day.

WA vaccine program suspended

Health Minister Kim Hames last night advised of the state-wide suspension as a precautionary measure.

He said the suspension came after a significant rise in the number of children who had developed a high temperature after receiving the vaccine.

He said some children had gone into febrile convulsions, a fit caused by a high fever, following the vaccinations.

Dr Hames said it was unclear if the fevers were related to the influenza vaccination but the precautionary measure was the most responsible course of action.

Fevers in most instances are treatable.

"People should give Paracetamol according to the instructions and tepid sponging to keep the temperature down." Dr Hames said.

"On rare occasions children can have a convulsion as the result of the high temperature and sometimes that can be prolonged, which can be a risk to the child."

He said parents should not take children under the age of five to be vaccinated against influenza until further notice.

CLICK HERE TO GO BACK TO MAIN PAGE................or HERE TO GO HOME

H1N1 vaccine study investigating hints of complications from vaccine

Federal health officials are investigating the first hints of any possible significant complications from the H1N1 vaccine, but stressed that the concerns will probably turn out to be a false alarm..........(ohhh of course they will!)

http://www.washingtonpost.com/wp-dyn/content/article/2010/04/23/AR2010042304965.html

The latest analysis of data has detected what could be a somewhat elevated rate of Guillain-Barré syndrome, which can cause paralysis and death; Bell's palsy, a temporary facial paralysis; and thrombocytopenia, which is a low level of blood platelets, officials reported Friday. The data is being collected through five of the networks the government is using to monitor people who were inoculated against the swine flu.

Officials stressed that it is far too early to know whether the vaccine was increasing the risk of those conditions or whether there is some other explanation, such as doctors identifying more cases because of the intensive effort to pinpoint any safety problems with the vaccine.

Based on the preliminary report, the Health and Human Services Department's National Vaccine Advisory Committee, which has been charged with monitoring the vaccine's safety, voted unanimously to follow up on the findings. "We're at the first step of determining whether there is a problem," Guthrie S. Birkhead, who chairs the committee, said during a teleconference in which a subcommittee of experts presented its latest findings on the data. "There's a lot more work to determine whether there is."

Marie McCormick, who led the subcommittee, said there was a good chance the indications of problems could disappear with further analysis. Even if the link with Guillain-Barrésyndrome is confirmed, the committee calculated the vaccine at most could be causing one extra case per 1 million people vaccinated.

"We have categorized this as a potential, not even a weak, signal," McCormick said, adding that no signs of problems have been seen in the other networks of data the government has been analyzing.

Even if the possible risks turn out to be real, officials stressed that the danger of the flu remains far greater.

"From everything we know right now, the influenza vaccine, including the H1N1 vaccine, is very safe, and it's much riskier to get influenza than the influenza vaccine," said Anne Schuchat of the federal Centers for Disease Control and Prevention.

Officials said they were not surprised that some possible problems that turn out to be false alarms might be found, given how intensively the vaccine's safety is being monitored.

The vaccine was administered to 350 million to 400 million people worldwide, including as many as 80 million Americans, as part of an unprecedented response to the first flu pandemic in decades.

Since the inoculation program was launched, health officials have been particularly concerned about Guillain-Barré syndrome, in part because a vaccine made in 1976 in response to a different strain of H1N1 influenza led to a small increase in the number of cases of the condition.

But officials expressed confidence that the new vaccine is safe because it was produced with the same methods employed since then to make the seasonal flu vaccine, which has been administered safely to millions of people.

Each year, about 3,000 to 6,000 people in the United States develop Guillain-Barré syndrome whether or not they were vaccinated -- a rate of one to two people out of every 100,000 people. Some studies have indicated that the seasonal flu vaccine might be associated with one additional case of the syndrome out of 1 million vaccinated. And influenza itself can cause the syndrome.

Although the vaccine was produced in record time, antiquated technology and unexpected problems growing the virus fast enough to produce the vaccine meant that most of the doses did not arrive until after the second wave of infections peaked last fall. That led to widespread anxiety, frustration and lines across the country as people scrambled to find the first doses. By the time most of the vaccine was ready, the second wave was already receding and demand fell sharply, leaving millions of doses unused.

The relatively low number of deaths compared with previous pandemics and the millions spent on the vaccine have led to charges that the World Health Organization exaggerated the pandemic's risks. That prompted the Geneva-based arm of the United Nations to launch two investigations, which are ongoing.

CLICK HERE TO GO BACK TO MAIN PAGE................or HERE TO GO HOME