Unpublished study influences Ont.’s vaccine plan
September 24 2009
Ontario says it is changing its approach to seasonal flu vaccine administration this year in part because of unpublished data that suggest the seasonal shot might raise the risk of catching swine flu.
Dr. Arlene King, the province’s chief medical officer of health, says people 65 and older, who aren’t at great risk of catching swine flu, will be offered seasonal flu vaccine in October.
But the seasonal flu won’t be offered to younger people in Canada’s most populous province until after they are first offered the vaccine for swine flu, which is likely to happen in November.
King says the unpublished study was clearly a factor in the decision to change the sequence of the vaccination program.
That study, based on research ongoing in British Columbia, Ontario and Quebec, suggests that people who have received seasonal flu shots last year may be at greater risk of catching H1N1 flu this year.
While the study is still being peer-reviewed in an unnamed journal, King said it had a direct influence on the policy for this year’s flu vaccination program in Ontario.
“There is emerging unpublished evidence that suggests an association between prior seasonal flu vaccination and getting the H1N1 flu. The nature of the association is unclear at this time, so we want people under 65 to wait to get the seasonal flu shot until after the H1N1 flu vaccine until we learn more about this,” she told reporters.
The other factors influencing the plan are evidence from the southern hemisphere that shows that H1N1 is dominating other seasonal flu strains.
The vaccines are also being phased in because of the difficulties of trying to provide both types of shots at the same time. That’s because the seasonal flu vaccine will be ready in October but swine flu vaccine won’t be ready until mid-November.
She added that there is still no scientific data that giving both swine flu and seasonal flu shots at the same time is either safe or effective. So Ontario will take a cautious approach and phase in both flu vaccine programs over three phases:
In October, the seasonal flu vaccine will be offered to Ontarians 65 years and over and residents of long-term care homes
H1N1 vaccine will be offered to the general population in November, following the vaccine sequencing guidelines issues by the Public Health Agency of Canada. That means high-priority groups first, and then the rest of the population
The seasonal flu vaccine will be then offered to all other residents six months of age and older who still want it.
“It’s a different flu season this year and rolling out two flu vaccine programs is a great example of how different it is,” Dr. King said.
Earlier in the day, the World Health Organization addressed the worries raised in the unpublished Canadian study in a telephone news briefing.
In a response to a question on the study from CTV’s Avis Favaro, Marie-Paule Kieny, director of the WHO’s initiative for vaccine research, said researchers in no other countries have made similar findings.
“We are in contact with other countries and having them look at their own data to see if they could have similar observations and none have been able to find anything like that,” Kieny told the teleconference from WHO headquarters.
“So the reason why this may be different in Canada and in this particular study is not yet identified. It may be study bias; it may be that something is real.
“But the WHO is looking forward to be able to see the data and to study data and to come to a better understanding of whether this has any chance of indeed putting people are risk, the fact that they’ve received the seasonal vaccination,” Kieny said.
Other provinces mull vaccine plan changes
Meanwhile, a number of Canadian provinces are considering suspending their seasonal flu vaccination programs, in part because of the worries.
Saskatchewan Health Minister Don McMorris said Thursday seasonal flu shots will likely be suspended for everyone in his province except seniors and those in long-term care.
Seniors are more susceptible to the seasonal flu, but their age group seems to be mostly immune from swine flu because of presumed exposure to similar viruses in their lifetimes.
McMorris said he was also worried about the reports that seasonal flu vaccine might make people more susceptible to swine flu. He added that other factors influencing their decision were expectation from flu officials that H1N1 would dominate this winter and crowd out seasonal flu strains.
In Quebec, health officials said earlier this week they’re putting the seasonal flu shot program on standby. They too are considering either delaying seasonal flu vaccination until after swine flu vaccine programs are complete, or scrapping seasonal flu vaccination altogether.
“For the moment, it’s on hold,” Karine White, a media relations liaison with the Ministry of Health and Social Services in Quebec told The Canadian Press.
Swine flu vaccination programs likely wouldn’t begin until mid-November, the earliest that the vaccine manufacturer will have it ready, tested and approved
What do we know about the vaccines’ safety? Not enough
Globe and Mail
August 06, 2009
Alan Cassels and Arthur Schafer
In the headlong rush to do good, we need to be sure we don’t end up doing harm. Who should be at the top of the list to receive the H1N1 vaccine or antiviral drugs if, as feared, they are in short supply? Bio-ethicists debate the niceties of how society should ration scarce medical resources, while public-health officials spend their days debating who should be first in line – pregnant women, health-care personnel or perhaps government leaders and corporate CEOs?
The majority of Canadians, listening to this rationing debate, would be forgiven for assuming that the H1N1 vaccine, when it becomes available in the autumn, will be a life saver. The unfortunate reality, however, is that we don’t know and, indeed, can’t know if that is the case.
Like most governments around the world, eager to appear to be “doing something,” the government of Canada has promised to stockpile enough of the vaccine so that most Canadians will be protected.
But, speaking of stockpiles, Canada already owns one of the world’s largest supplies of antiviral drugs, mostly Tamiflu and Relenza, two drugs designed to reduce the severity and length of the flu.
And yet the scientific evidence testing the preventive benefits of either Tamiflu or its near cousin, Relenza, shows that both are pathetically weak. People who take either of these “prophylactically,” i.e. before they become sick, hoping to prevent the flu, will get about as much effect as if they’d taken a placebo. That’s not a very impressive result.
Equally unimpressive: When the drugs are given within 48 hours
to someone who already has flu symptoms, with the goal of ameliorating the severity of the disease, it makes only a slight difference.
The “lucky ones” who take Tamiflu may reduce the average length of a five-day flu by about half a day. Not worth getting out of bed for, you might think. So perhaps it doesn’t matter all that much who is at the top of the list to receive the drugs and who is at the bottom.
Consider also that a recent international study reveals that about 50 per cent of children who have taken Tamiflu experienced side effects. Most have been minor (gut problems, diarrhea) but some have been more serious, including neuropsychiatric problems.
Why are public-health officials glossing over the fact there is a great deal of uncertainty and doubt surrounding the effectiveness, safety and side effects of flu drugs?
The same could be said for the H1N1 vaccine, currently in production and ramped up for Canada’s fall flu season. What do we know about its effectiveness or its safety?
The answer is, not enough. If one takes past flu campaigns as any indication, it is likely the effectiveness of the vaccine is going to be exaggerated, while the potential harms will either be ignored, understated or simply unknown. In that scenario, the rush to vaccinate yourself and your children might not turn out to be such a grand idea.
Public-health officials around the world seem to be suggesting there is a possibility this flu pandemic could get much worse, that is, become more lethal. If that were to happen, it seems “obvious” that wise people should seek to have a preventive flu shot or access to a pill. Many people will say to themselves:
Why not get the shot, just to be sure?
Part of the answer to that question is that until a million people
roll up their sleeves to get the vaccine, no one can be sure how safe it will be. This is also a decisive answer to those who favour making vaccination mandatory.
Some public-health officials have described flu vaccines as “highly effective,” but the internationally recognized Cochrane Collaboration (which accepts no money from the pharmaceutical industry) did a systematic review of all high-quality randomized trials (25 in all) studying influenza vaccination.
They concluded that “the evidence does
not support universal immunization of healthy adults.” Period.
So how does this information help us to think clearly about the current flu pandemic in which we’re mired?
Well, it seems that despite its spread, this flu virus is a bit of a
dud for the fear-mongers. If, as seems not unlikely, the H1N1 virus mutates, our government will have purchased enormous quantities of a flu vaccine around which we will have virtually no safety or effectiveness data, and an already existing and very costly stockpile of probably useless drugs.
In short, a big bust all around.
Governments and public-health officials are sensitive to the
exhortation: Don’t just stand there, do something. But it’s sometimes wise to reverse that dictum: Don’t just do something, stand there (and think a bit about what might actually produce more good than harm).
Alan Cassels is a drug policy researcher at the University of
Victoria. Arthur Schafer is director of the Centre for Professional and Applied Ethics at the University of Manitoba.
SOME QUESTIONS TO ASK:
1. Why did WHO raise the pandemic alert to highest level when less than one thousand people WORLDWIDE have died from causes “associated with h1n1″?
Pandemic alert level 6 allows martial law and mandatory vaccination. Many if not most of the people who have died had “underlying health problems.”
*Worldwide, the number of deaths attributed to the flu each year is between 250,000 and 500,000? (Thomas Walkom, The Toronto Star, May 1, 2009).”
*”…Only 700 people have died from the swine flu world wide in the last year. In the same period, half a million people died of the regular flu, but that isn’t called a pandemic. We are being lied to.” [other reports put the numbers at even less. and then there’s the epidemic of cancer, heart disease and diabetes…]
2. Poor quality testing to identify the specific flu strain. Some say it’s only accurate 1/2 the time, others say even less. How are tests made up? How quickly can you make up a test for something supposedly just discovered in May?
2a Where did this h1n1 come from. Some suggest it is made in a lab.
“This virus continues to be an enigma for virologists. In the April 30, 2009 issue of Nature, a virologist was quoted as saying,“Where the hell it got all these genes from we don’t know.” Extensive analysis of the virus found that it contained the original 1918 H1N1 flu virus, the avian flu virus (bird flu), and two new H3N2 virus genes from Eurasia. Debate continues over the possibility that swine flu is a genetically engineered virus. “
2b Hasty testing and preparation of the vaccine. Baxter Intl applied for the patent in 2008, long before the outbreak. How does that work?
“The Baxter vaccine, called Celvapan, has had fast track approval. It uses a new vero cell technology, which utilizes cultured cells from the African green monkey. This same animal tissue transmits a number of vaccine-contaminating
viruses, including the HIV virus.
“The Baxter company has been associated with two deadly scandals. The first event occurred in 2006 when hemophiliac components were contaminated with HIV
virus and injected in tens of thousands of people, including thousands of children. Baxter continued to release the HIV contaminated vaccine even after the contamination was known.
“The second event occurred recently when it was discovered that Baxter had released a seasonal flu vaccine containing the bird flu virus, which would have produced a real world pandemic, to 18 countries. Fortunately, astute lab workers in the Czech Republic discovered the deadly combination and blew the whistle before a worldwide disaster was unleashed.
*”GSK is one of several companies, including Novartis (NVS),
Sanofi-Aventis (SNY), and Baxter International (BAX), racing to
develop a swine flu vaccine. ” ie $$$$$$$$
3. Additives to vaccines are already a concern. Why the mercury, ie “thimerosal”? And now why this adjuvant called squalene which appears to mess with the immune system.
4. Historical precedent of the 1918 flu epidemic which killed about 40 million worldwide. There was a spring outbreak, then Rockefeller financed vaccination FOLLOWED by the major outbreak in the fall.
5. If you check the various provincial health web sites, they are no longer testing for the h1n1 and are lumping into their figures ALL cases of “influenza-like illness”. what kind of shoddy science is that??? why are they padding the numbers??
6. Pharma companies who are now making a killing already on sales of vaccines and antivirals like tamiflu, are NOT LIABLE for any damage caused by or as a result of these products.
7. Tamiflu has been considered useless by some doctors, in particular a Korean doctor. Others are playing down this information.
Government’s Tamiflu advice is wrong, says WHO
By Lewis Smith
August 22 2009
Only seriously ill and vulnerable patients should be prescribed antiviral drugs to help them to get over swine flu, the World Health Organisation said yesterday, in advice which conflicts with the decision taken by the British Government to prescribe Tamiflu to everyone with swine flu.
Most people will recover from swine flu within a week, just as they would from seasonal forms of influenza, the WHO said.
“Healthy patients with uncomplicated illness need not be treated with antivirals,” the WHO concluded in guidance issued on the internet. “Worldwide, most patients infected with the pandemic virus continue to experience typical influenza symptoms and fully recover within a week, even without any form of medical treatment.”
Swine flu, now present in 177 countries, has been blamed for 1,799 deaths, and it is feared that over-use of Tamiflu will lead to the virus becoming resistant to it. The WHO has been formally notified of 12 cases where the H1N1 virus has already been found to have developed resistance after mutating.
The WHO issued its advice after a panel of international experts reviewed the effectiveness and safety of antivirals in tackling the pandemic.
It agreed, however, that antivirals are appropriate in cases where patients suffer a severe bout of swine flu or have an underlying medical condition. In these cases the drugs have proved effective at reducing the risk of pneumonia setting in.
The Department of Health responded to the WHO guidance by saying that the decision to offer Tamiflu remained right and sensible.
“We believe a safety-first approach of offering antivirals, when required, to everyone remains a sensible and responsible way forward. However, we will keep this policy under review as we learn more about the virus and its effects,” a spokesman said.
Andrew Lansley, the shadow Health Secretary, has backed the Government’s approach, especially in the early stages of the outbreak when the severity of the disease was unclear.
He added: “In the light of this latest expert advice, it may be appropriate for GPs and the fluline to make clear to otherwise healthy patients that there may be little benefit in taking anti-virals. But I do not think it would be appropriate for us to not offer treatment to those who request it.”
The number of courses of antivirals issued in England by the National Pandemic Flu Service has almost halved since the beginning of the month. In the seven days up to 18 August there were 45,986 courses prescribed, compared to 90,363 the previous week. Last week there were 11,000 new cases of swine flu reported, down from 25,000 the week before.
In its advice the WHO included pregnant women as one of the at-risk groups that should continue to receive antivirals.
“As pregnant women are included among groups at increased risk, WHO recommends that pregnant women receive antiviral treatment as soon as possible after symptom onset,” it said.
The WHO recommended that children under five be regarded as being a high-risk group and should therefore be treated with antivirals as soon as possible once symptoms began.
Children over five years, however, should only be given the drugs if their condition becomes serious or if they have an underlying health problem.
Earlier this month a team of researchers from Oxford University said children with mild symptoms should not be given the antiviral to combat swine flu and urged the Department of Health to urgently rethink its [url]policy.
What’s the Danger of Swine Flu Vaccinations?
By Dr. Anders Bruun Laursen
August 20, 2009
There seems to be quite a lot of uncertainty about the technical nature of Swine Flu (H1N1) vaccines.
As a medical doctor, I wish to clarify a number of important issues: First, we should talk about vaccines instead of vaccine, since the vaccines vary as for their compositions and even their ways of being dispensed: some by injection, another by the nose.
I think the fears as for the vaccines can be referred to:
1. The adjuvants – in particular squalene which was in all probability responsible for the Gulf War syndrome,
2. The virus antigen´s condition (dead, attenuated, live)
3. A deeply rooted mistrust in our politicians and the vaccine producers´ motives and morals: e.g. Baxter´s live bird flu virus last Winter (12), the Bayer AIDS haemophiliac product scandal.
First it is necessary to understand, that pandemic vaccines are made according to two procedures:
1. The Developement of a totally new vaccine from scratch. This takes more time, administration and testing than mock up vaccines (see below).
2. A Mock-up vaccine is a vaccine with all the adjuvants of the pandemic vaccine – but without the killed or attenuated pandemic virus. This virus is – until the pandemic virus is known – a different, attenuated known potentially pandemic virus, in the case of the Pandemrix vaccine for the EU it is an attenuated H5N1 bird flu virus. This is the mock-up vaccine. When the nature of the pandemic swine flu virus (H1N1) is known, it replaces the H5N1 virus in an attenuated form, the adjuvants being left unchanged.
Until now mock-up vaccine test-vaccinations have been going on on voluntary ”human guinea pigs.” Since most of the contents of the vaccine has already been approved, the approval of the pandemic vaccine is easier to implement.
After the exchange of virus in the vaccine, the company will have to apply for a ”variation”. However, this is just a matter of form, since such a variation approval is given by the EU within 5 days – which means that there is no objective testing of the vaccine requiring official approval. The safety is entirely left to the vaccine producer, who has been granted immunity to actions of damages due to expected side effects.
So, as you see, there is no confusion with regard to swine flu and bird flu viruses. But there is another important consideration: the role of squalene.
The average quantity of squalene injected into the US soldiers abroad and at home in the anthrax vaccine during and after the Gulf War was 34.2 micrograms per billion micrograms of water. According to one study, this was the other cause of Gulf War syndrom in 25% of 697.000 US personnel at home and abroad. You can find this table of FDA analyses from the Gulf War lots on The Military Vaccine Resource Directory website.
a.. AVA 020 – 11 ppb squalene (parts per billion)
> b.. AVA 030 – 10 ppb squalene
> c.. AVA 038 – 27 ppb squalene
> d.. AVA 043 – 40 ppb squalene
> e.. AVA 047 – 83 ppb squalene
These values were confirmed by Prof. R. F. Garry before the House of Representatives. Prof Garry was the man to discover the connection between the Gulf War syndrome and squalene.
According to his findings, the Gulf War syndrome was caused by squalene, which was banned by a Federal Court Judge in 2004 from the Pentagon´s use.
As seen on p. 6 of this EMEA document , the Pandremix vaccine contains 10,68 mg of squalene per 0,5 ml. This corresponds to 2.136.0000 microgrammes pr. billion microgrammes of water, i.e. one million times more squalene per dose than in . There is any reason to believe that this will make people sick to a much higher extent than in 1990/91. This appears murderous to me.
I have contacted the Danish National Health Service: They are to decree mass vaccinations in Denmark – and yet they knew nothing about the composition of the Pandremix vaccine.
Then I addressed the Danish Medicinal Agency. They admitted that the Pandremix vaccine from GlaxoSmithKline does contain squalene and thimerosal. They have not rejected my remark that the squalene concentration is dangerous. In contrast, the AstraZeneca MedImmune nasal vaccination avoids squalene side effects.
So far the use of squalene has been banned by the FDA in the US according to Der Spiegel . However, this may not last long .
“Clearly bypassing the FDA requirements for safety testing of these new adjuvants and the vaccines which contain them puts the entire population at risk for serious, possibly life threatening side effects, particularly any of the 12,000 paid trial participants (6,000 children) who are unfortunate enough to be randomized into the adjuvant containing groups.”
Still, on July 23, 2009, the FDA announced, “Currently, no U.S. licensed vaccine contains the adjuvants MF-59 or ASO3 (squalene). It is expected that a novel influenza A (H1N1) vaccine manufactured using the same process as U.S. licensed seasonal inactivated influenza vaccine but administered with MF-59 or ASO3 will be authorized for emergency use only.”
Furthermore, “Two of the manufacturers (Novartis and GSK) have proprietary oil-in-water adjuvants (MF-59 and ASO3, respectively) which have been evaluated in a number of clinical studies including studies with influenza vaccines. These manufacturers will include an evaluation of the utility of the adjuvant for dose sparing and higher effect in their clinical studies.“
“The same document indicates that vaccines containing the un-approved adjuvants will be given to 100 children 6 months to 3 years old, 100 children 3 years old to 8 years, 100 individuals 18 to 64 years old and 100 individuals 65 and older in each of the multiple clinical trials. In addition, 700 individuals in each trial will be given non-adjuvanted vaccine”.
Now for the immunological side effects of squalene to occur takes months to years – and cannot be evaluated after up to 6 weeks of observation. Der Spiegel calls the mass vaccinations on Europeans a gigantic cost free experiment to provide the FDA with mass vaccination experience to clear the track for sale in the US.
EMEA admits that side effects can only be found through extensive vaccination campaigns! .
Here is what EMEA has to say about risks of GSK Pandemrix:
EMEAs Pandemrix is commonly or very commonly associated with a range of local and systemic adverse reactions but these are not often of severe intensity and the safety profile would not preclude the use of the vaccine in healthy adults aged 18-60 years or > 60 years.
However, there are some adverse reactions known to be very rarely associated with influenza vaccines and it is currently not possible to predict if higher rates might be observed with Pandemrix compared with, for example, seasonal influenza vaccines.
Dr Keiji Fukuda, the WHO’s flu chief, today warned about the potential dangers of the untested vaccine : “There are certain areas where you simply do not try to make any economies. One of the things which cannot be compromised is the safety of vaccines.”
Which is exactly what is going on!
What I do not know is, if they are going to leave the attenuated (or live – Baxter bird flu vaccine – or to totally replace it by the H1N1 virus.
Other severe, but rare side effects are autism in children due to thimerosal and the Guillan-Barré syndrome seen with 400-500 Americans after the 1976 unnecessary mass vaccinations against swine flu – videos. As for additional severe side effects of squalene – see Stephen Lendman .
My advice: If you are forced to be vaccinated against the harmless swine flu (H1N1) – demand a vaccination with the AstraZeneca nasal vaccine MedImmune– thereby avoiding squalene side effects.
Tamiflu: Swine flu drug increases stroke risk
While Tamiflu is one of the most effective drugs in treating swine flu infection, a new report warns that the drug may increase the risk of stroke.
Previously, researchers had urged parents to avoid using the drug in their offspring as its risks outweighed the benefits. Nausea and nightmares were among the most frequent side effects reported in children.
According to the report recently released by the Medicines and Healthcare products Regulatory Agency (MHRA), Tamiflu may interact with the blood-thinning medication warfarin, placing the individual at an increased risk of uncontrolled bleeding (INR rate).
A significant increase in the INR rate could consequently lead to the development of a hemorrhagic stroke.
Despite the fact that such a complication was never reported in performed clinical testing, the MHRA has received 418 reports of suspected adverse reactions including two deaths because of Tamiflu.
Some 12 of these reactions were related to warfarin interactions.
Warfarin is known to interact with a wide range of drugs and even some foods and drinks. Many of the consumers, therefore, are hospitalized due to increased INR rates while many others die.
“We have seen indications that INR rates could possibly rise due to interactions between warfarin and Tamiflu. However, flu-like illnesses have also been known to cause this, so at this stage it is difficult to know whether it is the interaction with Tamiflu or the underlying flu,” said a MHRA spokesman.
The government watchdog therefore warned physicians of the high risk of stroke in Tamiflu users, adding that they should ask the patients regarding the use of the blood-thinning drug before prescribing the anti-swine flu medicine.
Doctors told to watch for Guillain-Barre syndrome during Swine flu vaccination programme.
Doctors are being urged to watch for cases of Guillain-Barre syndrome, a rare nerve disorder, as the new swine flu vaccine is introduced in October.
Guillain-Barre syndrome which attacks the nervous system and can cause paralysis and death is linked to infections like flu but it has also been suggested a previous swine flu vaccine had caused cases of the disease in America in the 1970s.
American officials rushed out a vaccine in 1976 following an outbreak of swine flu in military barracks. Around 40million people received the vaccine but doctors reported an increase Guillain-Barre and 25 people had died before the immunisation programme was stopped.
It is not known for sure whether the vaccine or the flu was responsible and the current H1N1 swine flu jabs due to be introduced in Britain in October are very different to the version used thirty years ago, Government scientists have said.
However specialist doctors here are being urged to report every case of Guillain-Barre syndrome to the Health Protection Agency so the circumstances of each patient can be investigated.
Sources told the Daily Telegraph that experts are not expecting to spot any cases linked to the vaccinations.
They added that because Guillain-Barre can be caused by infections like flu, the new programme may in fact establish that vaccinations actually protect against the syndrome.
The syndrome affects around 1,500 people a year in the Britain.
A Health Protection Agency spokesman said enhanced surveillance was “routine” when introducing a new vaccine and all manner of potential side effects are monitored.
More than 13 million people in Britain, including people with severe asthma, diabetes, heart disease, kidney disease or with a compromised immune system will get the jab from October. Pregnant women and frontline health and social care workers will also be offered the jab.
The seasonal flu vaccination programme will continue as normal.
The spokesman said: “Guillain-Barre syndrome has long been identified as a potential adverse event that would require enhanced surveillance following the introduction of a pandemic vaccine but there is no evidence to suggest there is an increased risk of Guillain-Barre syndrome from this vaccine.”
He said there was also no increased risk of the syndrome associated with the seasonal flu vaccine.
“Establishing enhanced surveillance on Guillain-Barre syndrome has always been part of our pandemic plan because there is an increased risk of this disease after a flu-like illness.
“HPA is working in collaboration with the Association of British Neurologists Surveillance Unit (BNSU) and the British Paediatric Surveillance Unit (BPSU) who will ask clinicians to report each month whether they have seen any cases of Guillain-Barre syndrome.”
However critics have said the fact doctors are being told to report cases of Guillain-Barre syndrome is evidence that the authorities are concerned.
Jackie Fletcher of the campaign group, Jabs, added: “What we’ve got is a massive guinea-pig trial.”
A Department of Health spokesman said: “The European Medicines Agency has strict processes in place for licensing pandemic vaccines.
“In preparing for a pandemic, appropriate trials to assess safety and the immune responses have been carried out on vaccines very similar to the swine flu vaccine. The vaccines have been shown to have a good safety profile.
“It is extremely irresponsible to suggest that the UK would use a vaccine without careful consideration of safety issues. The UK has one of the most successful immunisation programmes in the world.”
Swine flu jab link to killer nerve disease: Leaked letter reveals concern of neurologists over 25 deaths in America
By Jo Macfarlane
August 15 2009
Prevention: Is the swine flu jab safe?
A warning that the new swine flu jab is linked to a deadly nerve disease has been sent by the Government to senior neurologists in a confidential letter.
The letter from the Health Protection Agency, the official body that oversees public health, has been leaked to The Mail on Sunday, leading to demands to know why the information has not been given to the public before the vaccination of millions of people, including children, begins.
It tells the neurologists that they must be alert for an increase in a brain disorder called Guillain-Barre Syndrome (GBS), which could be triggered by the vaccine.
GBS attacks the lining of the nerves, causing paralysis and inability to breathe, and can be fatal.
The letter, sent to about 600 neurologists on July 29, is the first sign that there is concern at the highest levels that the vaccine itself could cause serious complications.
It refers to the use of a similar swine flu vaccine in the United States in 1976 when:
* More people died from the vaccination than from swine flu.
* 500 cases of GBS were detected.
* The vaccine may have increased the risk of contracting GBS by eight times.
* The vaccine was withdrawn after just ten weeks when the link with GBS became clear.
* The US Government was forced to pay out millions of dollars to those affected.
Concerns have already been raised that the new vaccine has not been sufficiently tested and that the effects, especially on children, are unknown.
It is being developed by pharmaceutical companies and will be given to about 13million people during the first wave of immunisation, expected to start in October.
Top priority will be given to everyone aged six months to 65 with an underlying health problem, pregnant women and health professionals.
The British Neurological Surveillance Unit (BNSU), part of the British Association of Neurologists, has been asked to monitor closely any cases of GBS as the vaccine is rolled out.
One senior neurologist said last night: ‘I would not have the swine
flu jab because of the GBS risk.’
There are concerns that there could be a repeat of what became known as the ‘1976 debacle’ in the US, where a swine flu vaccine killed 25 people – more than the virus itself.
A mass vaccination was given the go-ahead by President Gerald Ford because scientists believed that the swine flu strain was similar to the one responsible for the 1918-19 pandemic, which killed half a million Americans and 20million people worldwide.
Swine flu vaccines being prepared
The swine flu vaccine being offered to children has not been tested on infants
Within days, symptoms of GBS were reported among those who had been immunised and 25 people died from respiratory failure after severe paralysis. One in 80,000 people came down with the condition. In contrast, just one person died of swine flu.
More than 40million Americans had received the vaccine by the time the programme was stopped after ten weeks. The US Government paid out millions of dollars in compensation to those affected.
The swine flu virus in the new vaccine is a slightly different strain from the 1976 virus, but the possibility of an increased incidence of GBS remains a concern.
Shadow health spokesman Mike Penning said last night: ‘The last thing we want is secret letters handed around experts within the NHS. We need a vaccine but we also need to know about potential risks.
‘Our job is to make sure that the public knows what’s going on. Why
is the Government not being open about this? It’s also very worrying if GPs, who will be administering the vaccine, aren’t being warned.’
Two letters were posted together to neurologists advising them of the concerns. The first, dated July 29, was written by Professor Elizabeth Miller, head of the HPA’s Immunisation Department.
It says: ‘The vaccines used to combat an expected swine influenza pandemic in 1976 were shown to be associated with GBS and were withdrawn from use.
‘GBS has been identified as a condition needing enhanced surveillance when the swine flu vaccines are rolled out.
‘Reporting every case of GBS irrespective of vaccination or disease history is essential for conducting robust epidemiological analyses capable of identifying whether there is an increased risk of GBS in defined time periods after vaccination, or after influenza itself, compared with the background risk.’
The second letter, dated July 27, is from the Association of British Neurologists and is written by Dr Rustam Al-Shahi Salman, chair of its surveillance unit, and Professor Patrick Chinnery, chair of its clinical research committee.
America swine flu 1976
Halted: The 1976 US swine flu campaign
It says: ‘Traditionally, the BNSU has monitored rare diseases for long periods of time. However, the swine influenza (H1N1) pandemic has overtaken us and we need every member’s involvement with a new BNSU survey of Guillain-Barre Syndrome that will start on August 1 and run for approximately nine months.
‘Following the 1976 programme of vaccination against swine influenza in the US, a retrospective study found a possible eight-fold increase in the incidence of GBS.
‘Active prospective ascertainment of every case of GBS in the UK is required. Please tell BNSU about every case.
‘You will have seen Press coverage describing the Government’s concern about releasing a vaccine of unknown safety.’
If there are signs of a rise in GBS after the vaccination programme begins, the Government could decide to halt it.
GBS attacks the lining of the nerves, leaving them unable to transmit signals to muscles effectively.
It can cause partial paralysis and mostly affects the hands and feet. In serious cases, patients need to be kept on a ventilator, but it can be fatal.
Death is caused by paralysis of the respiratory system, causing the victim to suffocate.
It is not known exactly what causes GBS and research on the subject has been inconclusive.
However, it is thought that one in a million people who have a seasonal flu vaccination could be at risk and it has also been linked to people recovering from a bout of flu of any sort.
The HPA said it was part of the Government’s pandemic plan to monitor GBS cases in the event of a mass vaccination campaign, regardless of the strain of flu involved.
But vaccine experts warned that the letters proved the programme was a ‘guinea-pig trial’.
Dr Tom Jefferson, co-ordinator of the vaccines section of the influential Cochrane Collaboration, an independent group that reviews research, said: ‘New vaccines never behave in the way you expect them to. It may be that there is a link to GBS, which is certainly not something I would wish on anybody.
‘But it could end up being anything because one of the additives in one of the vaccines is a substance called squalene, and none of the studies we’ve extracted have any research on it at all.’
He said squalene, a naturally occurring enzyme, could potentially cause so-far-undiscovered side effects.
Jackie Fletcher, founder of vaccine support group Jabs, said: ‘The Government would not be anticipating this if they didn’t think there was a connection. What we’ve got is a massive guinea-pig trial.’
Professor Chinnery said: ‘During the last swine flu pandemic, it was observed that there was an increased frequency of cases of GBS. No one knows whether it was the virus or the vaccine that caused this.
‘The purpose of the survey is for us to assess rapidly whether there is an increase in the frequency of GBS when the vaccine is released in the UK. It also increases consultants’ awareness of the condition.
Panic over? The number of swine flu cases has fallen sharply in the past few weeks.
‘This is a belt-and-braces approach to safety and is not something people should be substantially worried about as it’s a rare condition.’
If neurologists do identify a case of GBS, it will be logged on a central database.
Details about patients, including blood samples, will be collected and monitored by the HPA.
It is hoped this will help scientists establish why some people develop the condition and whether it is directly related to the vaccine.
But some question why there needs to be a vaccine, given the risks. Dr Richard Halvorsen, author of The Truth About Vaccines, said: ‘For people with serious underlying health problems, the risk of dying from swine flu is probably greater than the risk of side effects from the vaccine.
‘But it would be tragic if we repeated the US example and ended up with more casualties from the jabs.
‘I applaud the Government for recognising the risk but in most cases this is a mild virus which needs a few days in bed. I’d question why we need a vaccine at all.’
Professor Miller at the HPA said: ‘This monitoring system activates pandemic plans that have been in place for a number of years. We’ll be able to get information on whether a patient has had a prior influenza illness and will look at whether influenza itself is linked to GBS.
‘We are not expecting a link to the vaccine but a link to disease, which would make having the vaccine even more important.’
The UK’s medicines watchdog, the Medicines and Healthcare Products Regulatory Agency, is already monitoring reported side effects from Tamiflu and Relenza and it is set to extend that surveillance to the vaccine.
A Department of Health spokesperson said: ‘The European Medicines Agency has strict processes in place for licensing pandemic vaccines.
‘In preparing for a pandemic, appropriate trials to assess safety and the immune responses have been carried out on vaccines very similar to the swine flu vaccine. The vaccines have been shown to have a good safety profile.
‘It is extremely irresponsible to suggest that the UK would use a vaccine without careful consideration of safety issues. The UK has one of the most successful immunisation programmes in the world.’
I COULDN”T EAT OR SPEAK… IT WAS HORRENDOUS
Victim: Hilary Wilkinson spent three months in hospital after she was diagnosed with Guillain-Barre Syndrome
When Hilary Wilkinson woke up with muscle weakness in her left arm and difficulty breathing, doctors initially put it down to a stroke.
But within hours, she was on a ventilator in intensive care after being diagnosed with Guillain-Barre Syndrome.
She spent three months in hospital and had to learn how to talk and walk again. But at times, when she was being fed through a drip and needed a tracheotomy just to breathe, she doubted whether she would survive.
The mother of two, 57, from Maryport, Cumbria, had been in good health until she developed a chest infection in March 2006. She gradually became so weak she could not walk downstairs.
Doctors did not diagnose Guillain-Barre until her condition worsened in hospital and tests showed her reflexes slowing down. It is impossible for doctors to know how she contracted the disorder, although it is thought to be linked to some infections.
Mrs Wilkinson said: ‘It was very scary. I couldn’t eat and I couldn’t speak. My arms and feet had no strength and breathing was hard.
I was treated with immunoglobulin, which are proteins found in blood, to stop damage to my nerves. After ten days, I still couldn’t speak and had to mime to nurses or my family.
‘It was absolutely horrendous and I had no idea whether I would get through it. You reach very dark moments at such times and wonder how long it can last.
But I’m a very determined person and I had lots of support.’
After three weeks, she was transferred to a neurological ward, where she had an MRI scan and nerve tests to assess the extent of the damage.
Still unable to speak and in a wheelchair, Mrs Wilkinson eventually began gruelling physiotherapy to improve her muscle strength and movement but it was exhausting and painful.
Three years later, she is almost fully recovered. She can now walk for several miles at a time, has been abroad and carries out voluntary work for a GBS Support Group helpline.
She said: ‘It makes me feel wary that the Government is rolling out this vaccine without any clear idea of the GBS risk, if any. I wouldn’t wish it on anyone and it certainly changed my life.
‘I’m frightened to have the swine flu vaccine if this might happen again – it’s a frightening illness and I think more research needs to be done on the effect of the vaccine.’
Hotline staff given access to confidential records
Confidential NHS staff records and disciplinary complaints could be accessed by hundreds of workers manning the Government’s special swine flu hotline.
They were able to browse through a database of emails containing doctors’ and nurses’ National Insurance numbers, home addresses, dates of birth, mobile phone numbers and scanned passport pages – all details that could be used fraudulently.
And private and confidential complaints sent by hospitals about temporary medical staff – some of whom were named – were also made available to the call-centre workers, who were given a special password to log in to an internal NHS website.
It could be a breach of the Data Protection Act.
The hotline staff work for NHS Professionals, which was set up using taxpayers’ money to employ temporary medical and administrative staff for the health service.
The not-for-profit company runs two of the Government’s swine flu call centres – with 300 staff in Farnborough, Hampshire, and 900 in Watford, Hertfordshire.
Shadow Health Secretary Andrew Lansley described the revelations as ‘disturbing’.
Anne Mitchell, a spokeswoman for Unison, said: ‘There’s no excuse for such a fundamental breach of personal security. Action needs to be taken as soon as possible to make sure this does not happen again.’
A spokeswoman for NHS Professionals would not confirm whether access to the confidential files had been granted.
Swine Flu Vaccine Makers to Profit $50 Billion a Year!! Or more. Some drug companies to date have been selling it at 6 times what it costs to make. So if it cost $5 to make they sell it for $30.