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.

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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.

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Suspicious H1N1's Origins

On April 24, AP reported that "Health officials are investigating a never-before-seen form of the flu that combines pig, bird and human viruses.... (It's) a growing medical mystery because it's unclear how (affected people) caught the virus. None (of seven cited had) contact with pigs." Nor had others reportedly affected in other US cities.



The "intercontinental" mixture included North American Swine Flu, North American Avian Flu, human H1N1 flu, and a fourth H3N2 strain found in Asia and Europe.

Suspicions about a synthetic laboratory-made virus have surfaced. Writing in NewsMax.com, Dr. Russell Blaylock quoted an unnamed virologist saying: "Where the hell it got all these genes we don't know." According to Blaylock: "Debate continues over the possibility that swine flu is a genetically engineered virus."

Dallas County Medical Director Dr. John Carlo voiced concern about the possibility that:
"This strain of swine influenza (may have been) cultured in a laboratory....something that's not been seen anywhere actually in the United States and the world...."
Recently interviewed on Russia Today TV, investigative journalist Wayne Madsen cited a University of Wisconsin lab conducting joint influenza vaccine research with drug company FluGen. On March 24, Reuters reported that:
"FluGen, Inc., an emerging leader in the development, production and delivery of influenza vaccines and related products, today announced it has secured exclusive rights to a novel, patent-protected vaccine-delivery technology (that) painlessly delivers seasonal and pandemic influenza vaccines."
Madsen believes "the Swine Flu virus began in a lab," the objective being profits for vaccine makers with products "that may not actually be safe." Many noted experts share that view about all vaccines.
NutriMedical founder Dr. William Deagle reported that 6-8% of Swine Flu DNA matches no virus on record. He believes more lethal strains may appear in the fall.
Project Camelot "provide(s) a vehicle for researchers and whistle-blowers to get their stories out." Interviewed on its Whistleblower Radio show, Burk Elder Hale claimed that a senior drug company biochemist (unnamed to protect him) told him:
"....an aerosoled precursor has been put into the air and almost everyone has breathed it into their lungs. (When Swine Flu) vaccines (are) administered in the fall, (they'll) be activated when (their) constituents come into contact with the aerosoled precursor in the body and will cause a rapid spread of the H1N1 influenza A virus. The biochemist is very upset about the matter....and is a very reliable source that needs our utmost protection."

Catherine Austin Fitts is a former high-level US government official and Wall Street insider. She's now the editor of Solari.com and runs Solari, Inc. as an "online media company focusing on ethical investment and preserving family wealth."

Admitting she's no expert, she wrote this about Swine Flu on July 22:
"I believe one of the goals of the swine flu vaccine is depopulation. Perhaps it is the goal of a swine flu epidemic as well, whether bio-warfare or hype around a flu season....Lowering immune systems and increasing toxicity levels combined with poor food, water and terrorizing stress will help do the trick....a plague can so frighten and help control people that they will accept the end of their current benefits....without objection. And a plague with proper planning can be highly profitable. Whatever the truth (about) swine flu and related vaccines....it can be used (to) control (a) situation that is quickly shifting out of control."

"In short, an epidemic can be used to offset the inflation of capital with increasing deflation of the value and income of labor and continual demand destruction. (What's coming next is the) meaner face of 'the establishment against the rest of society.' "

The possibility of a diabolical depopulation scheme can't be dismissed. The idea's been around for decades, including from the 1974 Henry Kissinger project - National Security Study Memorandum 200 (NSSM 200). It was backed by powerful economic interests to cull the world population of useless feeders so corporate giants could exploit world resources unimpeded.

Kissinger's scheme was to make birth control a prerequisite for US aid. He wanted the annual death rate doubled and for a population decline in the hundreds of millions by 2000. Poor third world women in countries like Brazil were involuntarily sterilized. Millions were harmed then. Perhaps today's toll from mandatory global Swine Flu vaccinations will be billions.

Yet US laws were passed to prevent it. In 1986, the National Childhood Vaccine Injury Act (NCVIA) required:

-- giving parents written information on vaccine benefits and risks so they could decide on what was safe for their children;

-- maintaining a permanent record of all vaccines given children, including producer names and lot numbers;

-- keeping up to date medical records of all vaccinations given children; and

-- recording all serious health problems after vaccinations were administered and notifying the federal Vaccine Adverse Event Reporting System (VAERS) immediately.

At issue is whether federal laws and constitutional and Nuremberg protections will help. Nuremberg requires voluntary consent with full disclosure of known risks and avoidance of experimental treatments if there's any reason to believe harm may result. The Fifth Amendment protects against abusive government authority in stating that "No person shall....be deprived of life, liberty or property, without due process of law...." The Eighth Amendment prohibits "cruel and unusual punishments." Harming human health is cruel and abusive. Mandating suspect drugs violates Nuremberg, the US Constitution, and other protective laws. Whether they'll be enforced is another matter.



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Rotarix rotavirus vaccine contaminated, officials say

(CNN) -- Federal health authorities recommended Monday that doctors suspend using Rotarix, one of two vaccines licensed in the United States against rotavirus, saying the vaccine is contaminated with material from a pig virus.


http://www.cnn.com/2010/HEALTH/03/22/rotavirus.vaccine/

"There is no evidence at this time that this material poses a safety risk," Food and Drug Administration Commissioner Dr. Margaret Hamburg told reporters in a conference call.

Rotarix, made by GlaxoSmithKline, was approved by the FDA in 2008. The contaminant material is DNA from porcine circovirus 1, a virus from pigs that is not known to cause disease in humans or animals, Hamburg said.

About 1 million children in the United States and about 30 million worldwide have gotten Rotarix vaccine, she said.

Rotavirus disease kills more than 500,000 infants around the world each year, primarily in low- and middle-income countries, she said. Before rotavirus vaccine became available, the disease was blamed for more than 50,000 hospitalizations and several dozen deaths per year in the United States, she said.

The FDA learned about the contamination after an academic research team using a novel technique to look for viruses in a range of vaccines found the material in GlaxoSmithKline's product and told the company, Hamburg said. The drug maker confirmed its presence in both the cell bank and the seed from which the vaccine is derived, suggesting its presence from the early stages of vaccine development, she said. The FDA then confirmed the drug maker's findings.

GlaxoSmithKline emphasized Monday that the pig virus is not known to cause illness in humans, saying "it is found in everyday meat products and is frequently eaten with no resulting disease or illness."

"No safety issue has been identified by external agencies or GSK," Thomas Breuer, the drug maker's chief medical officer, said in a written statement. "GSK is committed to patient safety and to the highest manufacturing standards for all our vaccines and medicines. We are already working closely and discussing this finding with regulatory agencies around the world."

Another vaccine, RotaTeq, is made by Merck and was approved in 2006. There is no evidence that the Merck product is affected, Hamburg said. Both vaccines are given by mouth to infants to prevent rotavirus disease, which is marked by severe diarrhea and dehydration.

Asked whether Merck would be able to meet the nation's demand, Merck spokeswoman Pam Eisele said, "Obviously, we will work with the ... FDA to evaluate supply needs."

In the next four to six weeks, the drug agency will convene an advisory committee to make recommendations and seek input on the use of new techniques for identifying viruses in vaccine, Hamburg said.

"We're not pulling it from the market, we're just suspending its use during this period while we're collecting more information," she said. "It should not be in this vaccine product and we want to understand how it got there. It's not an easy call and we spent many long hours debating the pros and cons but, because we have an alternative product and because the background rates of this disease are not so severe in this country, we felt that the judicious thing to do was to take a pause, to really ask the critical questions about what this material was doing in the vaccine, how it got there."

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, said "a substantial amount" of the DNA was found in the vaccine. But, he stressed, "there is no evidence that it causes any disease. ... There is no evidence that it ever does anything."

The research group that discovered the contamination has asked not to be identified pending its paper's publication in a scientific journal, Hamburg said.

Anyone who has already received a dose of Rotarix should switch to the Merck product for the next two doses, Hamburg said. Preliminary testing of the Merck product has found no evidence of the porcine circovirus 1 DNA, she said. Doctors should be able to tell parents which of the two products their children received, she said.

Hamburg stressed that the suspension applies only to the United States. Public health officials in countries where the incidence of rotavirus is more severe may decide that the benefits of continuing to use the vaccine outweigh any concerns raised by the contamination, she said. "Such a decision would be very understandable," she added.

A similar virus, porcine circovirus 2, also does not cause disease in humans, but it does cause disease in its pig host, Hamburg said.

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