Swine Flu Vaccine
Manufacturers Data For Two Brands of Swine Flu Jab, Prepandrix and Celvapan
CELVAPAN BY BAXTER
Ingredients:
Active ingredient (I assume this is bird/pig/human engineered flu virus, which is listed as whole cell virus),vero cell line (diseased monkey tissue that the virus was grown on which will be present in the vaccine in trace amounts), haemmaglutinin, tween 80 (this is polysorbate 80), sodium chloride, tris (trometamol), water.
HAEMMAGLUTININ - This causes red blood cells to clump together.
Tween 80 - a stabilizer that is a known infertility agent. Linked to infertility in male painters and decorators due to it being in some paints. Used by the population council of WHO in developing pregnancy vaccines since the 1960's. I will post more info on this site soon about this.
Sodium Chloride - this is refined table salt which is bad for your heart and clogs up your arteries. It is particularly bad for children as they can't take as much salt as adults. A healthier kind of salt is sea salt or rock salt, rather than the refined version.
Tris - a buffer which is also an anti-inflammatory drug that has numerous side-effects including asthma and heart attack. Contraindications to Tris are:
Active or previous peptic ulcer. History of upper gastrointestinal bleeding or perforation, related to previous NSAID therapy.
suspected or confirmed cerebrovascular bleeding
haemorrhagic diatheses, including coagulation disorders
hypersensitivity to ketorolac trometamol or other NSAIDs and those patients in whom aspirin or other prostaglandin synthesis inhibitors induce allergic reactions (severe anaphylactic-like reactions have been observed in such patients)
the complete or partial syndrome of nasal polyps, angioedema or bronchospasm
concurrent treatment with other NSAIDs including cyclooxygenase 2 specific inhibitors, oxpentifylline, probenecid or lithium salts
hypovolaemia from any cause or dehydration
moderate or severe renal impairment (serum creatinine > 160 micromol/l)
a history of asthma
severe heart failure
patients who have had operations with a high risk of haemorrhage or incomplete haemostasis
patients on anti-coagulants including low dose heparin (2500 - 5000 units twelve hourly)
during pregnancy, labour, delivery or lactation
children under 16 years of age
Ketorolac is contra-indicated as prophylactic analgesia before surgery due to inhibition of platelet aggregation and is contra-indicated intra-operatively because of the increased risk of bleeding
patients currently receiving aspirin
Despite the fact that Tris IS NOT SUITABLE FOR CHILDREN UNDER 16, IT IS IN THE SWINE FLU VACCINE WHICH WILL BE GIVEN TO CHILDREN UNDER THIS AGE.
SAFETY DATA AND SIDE-EFFECTS
A previous version of Celvapan which was a H5N1 vaccine (bird flu) had the following side effects:
Injection site reactions, headache, arthralgia, myalgia.
These were only THE MOST COMMON side-effects, the NHS did not include details of more serious side-effects for its staff.
THERE IS NO DATA YET FOR THE H1N1, swine/bird/human flu, I.E. THIS IS A BIG EXPERIMENT. THEY HAVE NO IDEA OF THE SAFETY BEFORE THEY INJECT YOUR CHILD!
CONTRAINDICATIONS
INFORMATION NOT YET AVAILABLE!!!!
PREPANDRIX BY GSK
Ingredients:
Haemagglutinin, split cell virus grown in egg, Adjuvant (AS03)squalene, Alpha-tocopherol, polysorbate 80, Octoxynol 10, Sodium chloride, Disodium phosphate, Potassium dihydrogen phosphate, potassium chloride, magnesium chloride, thimerosal, water.
For heamagglutinin, polysorbate 80 and sodium chloride see further up page for explanations.
Alpha-tocopherol - E number E307.
Octoxynol 10 - A SPERMICIDE!!! According to doctor Jane Harrison-Hohner from Web MD,
"The active ingredients in spermicides are surfactants that attack the sperm membrane and immobilize the sperm: nonoxynol-9, -10, or -11, and octoxynol-9,-10, 13, and-40. Aerosol foams and creams tend to disperse better in the vagina; spermicides are also available as inserts and vaginal film."
The mind boggles as to why they are putting a known spermacide into a vaccine.
Disodium phosphate - a sodium salt of phosphoric acid used as an anti-caking agent.
Potassium dihydrogen phosphate - a food additive and fungacide.
Potassium Chloride - this is potassium and chlorine. Used in processed foods, medicines and in the LETHAL INJECTION. Too much potassium chloride paralysis's you so you are unable to breathe, hence it's use as a method of execution.
Magnesium Chloride - this is magnesium and chlorine, a powerful infection fighter and helps regenerate cells. They probably put that in there to counter all the crap they put in the vaccine.
Thimerosal - a 50% mercury compound, BANNED as an added ingredient from childhood vaccines but then the US introduced flu vaccines into the childhood schedule at the same time, which had thimerosal in them. Proven to cause developmental disorders and implicated in autism (See mercury, vaccines and autism page).
Squalene - an oil found in shark livers. Triggered arthritis in rats and implicated in Gulf War Syndrome.
SAFETY DATA AND SIDE-EFFECTS
THERE IS NO DATA YET FOR THE H1N1, swine/bird/human flu, I.E. THIS IS A BIG EXPERIMENT. THEY HAVE NO IDEA OF THE SAFETY BEFORE THEY INJECT YOUR CHILD!
CONTRAINDICATIONS
INFORMATION NOT YET AVAILABLE!!!!
Who do they want to vaccinate and how many doses?
They want to give people 2 doses of vaccine, 3 weeks apart.
They want to vaccinate the following groups:
Priority groups:
Children aged 3 to 16 who are NOT high risk
Household contacts of the immuno-compromised
Those aged 16-64 who are not in the above groups
Health and social care workers.
Other groups:
Those less than 65 in high risk groups including pregnant women
Children under 5 years as part of the childhood immunisation schedule
School aged children in a schools based programme
All other adults.
Since writing this the vaccine has been stopped for under 5 year old's which was in part driven by lack of demand. The vaccine also caused seizure disorders in children in Australia and resulted in the death of a 2 year old, so the programme was stopped and this may have had some bearing on the UK's decision - 18th January 2011.
SO BASICALLY THEY WANT TO VACCINATE EVERYBODY IN THE WHOLE COUNTRY/WORLD!!
Sources
http://209.85.229.132/search?q=cache:RbuvyWzwBe4J:www.nes.scot.nhs.uk/hai/pandemic_flu/documents/H1N1v1.003-08-09.pdf+Celvapan+data+sheet&cd=8&hl=en&ct=clnk&gl=uk&client=firefox-a
H1N1 Immunisation Programme - a resource pack to support the training of immunisers, nhs.
http://emc.medicines.org.uk/medicine/20922/SPC/Ketorolac%2030mg%20ml%20solution%20for%20injection%20(Beacon%20Pharmaceuticals)/#EXCIPIENTS
Data sheet for trometamol injection.
http://ajp.amjpathol.org/cgi/content/abstract/156/6/2057
http://boards.webmd.com/webx?THDX@@.89b5dc5b!thdchild=.89b5dc5b/0
Web MD page.
Test Subject Becomes ill, Researchers Deny It
A harmless prick and thereby possibly save thousands of people. This is what several hundreds of volunteers thought, who each collected a payment of 250 Euro for their participation in the study of the swine flu vaccine trial at the Ludwig-Maximilians-University.
One of them has now quit the trial: The Diploma-businessman Axel Sch. (40). He claims : "The vaccination has made me ill! the test is irresponsible. He says that within a few hours after the vaccination, on August 10, he had sweat on his forehead. "I felt totally beat. On the third day, my kidneys and head were aching and I got a fever. I then had a coughing fit - and the wash basin was suddenly red - it was blood!
LMU-medical researcher Frank von Sonnenburg, who is in charge of the country-wide study, doesnt consider these accounts credible. He says that such side-effects cannot be related to the vaccine. He does not deny that, as with other flu-vaccinations, flu-like symptoms may occur as a reaction to the vaccination. "Additionally, there may be light pain, redness or swelling at the injection site."
"Obviously many of the test subjects would have side-effects. We do such a study precisely because we want to find out any possible side-effects. If flu cases were to become more severe and we had not done any tests, there would be a big outcry by everyone."
Was the vaccine admitted too quickly to the study? The fact is that in this composition, the vaccine has not yet been applied to humans. The Federal Health Minister Ulla Schmidt explained on Wednesday that she had felt put under pressure by the pharmaceutical industry from the beginning. Criticism is being voiced with increasing frequency. The Paul-Ehrlich-Institute points out that side-effects to this vaccine are to be more expected than in connection with a normal flu-vaccine. The Paediatric Association points to a possibly increased number of unknown side-effects.
British researchers even warn about a neurological disorder known as the Guillain-Barré-Syndrome. They point to a vaccination campaign with a similar swine flu vaccine carried out in the USA in 1976, which resulted in the deaths of 25 people.
Probably because of this, the USA only test vaccines without so-called adjuvants. These lead to greater side-effects, explains study leader Frank von Sonnenburg. "The adjuvants produce more anti-bodies, which is why the bodys defensive reaction is also greater." Kidney pains and bloody cough of the kind Axel Sch. Experienced were however not to be expected, even with this adjuvant. "We conduct a clean study."
Axel Sch. however insists that his complaints were a result of the vaccination. "Surely it is no coincidence that they occurred directly after the vaccination." He criticizes the university, saying that he was not properly informed prior to the study. He said that for three days he was flat on his back during this heat. "When I phoned the LMU, they simply asked me the question needed to fill in their form and told me to see my doctor." He now wants the medical costs and loss of earnings compensated by the medical insurance covering the trial.
Axel Sch. has participated in medical trials even when he was a student. He had also had good experiences with an LMU flu-vaccine study. "This is the reason why I immediately consented when they asked me if I would test the new vaccine."
Now his trust in research is gone, he is quitting the vaccine trial. In October he will fly to Latin America for professional reasons. He had looked forward to traveling unconcerned by then he would have received the second of three vaccinations. "Im not fearful just the same I dont belong to an at risk group. Also, the swine flu cant possibly be as bad as the side-effects of the vaccine."
Translation into English by Erwin Alber.
Source: merkur-online.de, Münchner klagt über Horror-Nebenwirkungen Forscher weisen Vorwürfe zurück, 21 August 2009.
VAN UK'S Comment: What is the point of tests if the researchers won't accept any side-effect except redness and swelling at the injection site?
This points to how fraudulant these so called safety tests are.
Manufacturers Data Sheet For Pandemrix Vaccine, Based on Seasonal Flu Vaccines As They Don't Have The Data
All Ferrets Vaccinated in Animal Tests Died 3 to 4 Days Later!
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14). Doses of 15, 5, 1.7 or 0.6 micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 micrograms of HA were tested in the heterologous challenge experiment. Control groups included ferrets immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered saline solution. Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05. Of the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or heterologous challenge, respectively. Viral shedding into the upper respiratory tract was also reduced in vaccinated animals relative to controls, suggesting a reduced risk of viral transmission. In the unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be euthanized as they were moribund, three to four days after the start of challenge.
VAN UK'S Comment: Moribund means dying or near death.
INGREDIENTS:
Split influenza virus, inactivated, containing antigen* equivalent to:
A/California/7/2009 (H1N1)v-like strain (X-179A) 3.75 micrograms**
* propagated in eggs
** haemagglutinin
This vaccine complies with the WHO recommendation and EU decision for the pandemic.
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams)
The suspension and emulsion, once mixed, form a multidose vaccine in a vial. See section 6.5 for the number of doses per vial.
Excipients: the vaccine contains 5 micrograms thiomersal.
Suspension vial:
Polysorbate 80
Octoxynol 10
Thiomersal
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Magnesium chloride (MgCl2)
Water for injections
Emulsion vial:
Sodium chloride (NaCl)
Disodium hydrogen phosphate (Na2HPO4)
Potassium dihydrogen phosphate (KH2PO4)
Potassium chloride (KCl)
Water for injections
Adverse Reactions:
They have taken this information from trials of H5N1 (bird flu) vaccine, as NONE have been done on H1N1 vaccine!
Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing A/Vietnam/1194/2004 (H5N1) strain with at least 3.75 microgram HA/AS03.
Blood and lymphatic system disorders
Common: lymphadenopathy
Psychiatric disorders
Uncommon: insomnia
Nervous system disorders
Very common: headache
Uncommon: paraesthesia, somnolence, dizziness
Gastrointestinal disorders
Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)
Skin and subcutaneous tissue disorders
Common: ecchymosis at the injection site, sweating increased
Uncommon: pruritus, rash
Musculoskeletal and connective tissue disorders
Very common: arthralgia, myalgia
General disorders and administration site conditions
Very common: induration, swelling, pain and redness at the injection site, fever, fatigue
Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus)
Uncommon: malaise.
Post-marketing surveillance of H1N1 vaccine - i.e. they only studied the vaccine AFTER they introduced it, as all effects listed above are for H5N1 vaccine, making YOU the experiment!
Immune system disorders
Anaphylaxis, allergic reactions
Nervous system disorders
Febrile convulsions
Skin and subcutaneous tissue disorders
Angioedema, generalised skin reactions, urticaria
Interpandemic trivalent vaccines
From Post-marketing surveillance with interpandemic trivalent vaccines, the following adverse reactions have also been reported:
Rare:
Neuralgia, transient thrombocytopenia.
Very rare:
Vasculitis with transient renal involvement.
Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur (see section 4.4).
Pre-Clinical Safety Data
This was taken from H5N1 (bird flu) vaccination so they have NO PRE-CLINICAL SAFETY DATA ON H1N1 VACCINE!!
Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation period).
Use in Pregnancy
There are currently no data available on the use of Pandemrix in pregnancy.
Interactions with Other Drugs
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
So you should not have other vaccines with this vaccine.
Contraindications:
I think this information was taken from seasonal flu vaccine information, as nowhere in the ingredients or excipients can I find formaldehyde or gentamycin, so I think they have lifted it from that data sheet:
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine. If vaccination is considered to be necessary, facilities for resuscitation should be immediately available in case of need.
Efficacy (whether or not the vaccine works):
There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1) in children and adolescents aged from 3-17 years or in children aged less than 6 months. There are very limited data available from a clinical study with Pandemrix (H1N1) in healthy children aged from 6 to 35 months and limited data from a study with a version of Pandemrix containing H5N1 antigens in children aged from 3 to 9 years.
Very limited data in children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses indicate an increase in the rates of injection site reactions and general symptoms (see section 4.8). In particular rates of fever (axillary temperature GREATER-THAN OR EQUAL TO (8805)38°C) may increase considerably after the second dose. Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each vaccination.
There are no data on administration of AS03-adjuvanted vaccines before or following other types of influenza vaccines intended for pre-pandemic or pandemic use.
A protective immune response may not be elicited in all vaccinees.
Source: http://emc.medicines.org.uk/medicine/22352/SPC/Pandemrix+suspension+and+emulsion+for+emulsion+for+injection/#CLINICAL_PRECAUTIONS
Swine Flu Vaccine to Be Burned - Releasing Mercury into the Air, Massive Pollution
An estimated 40 million doses of H1N1 vaccine expired Wednesday and will be thrown away, the U.S. Department of Health and Human Services, says. Federal officials say the expired vaccine accounts for nearly 25 percent of the 162 million doses of swine flu vaccine that were available for public use. The vaccine will be crushed and then incinerated.
According to HHS, an estimated 90 million doses of the vaccine was dispensed in 2009-2010. Eighty million Americans were vaccinatedabout 25 percent of the populationchildren under 9 years old got two doses. Approximately 32 million doses remain in storage, set to expire at various times next year.
Source: CNN Health, 1st July 2010.
Narcolepsy after H1N1 Vaccine
Sweden's Medical Products Agency opened an inquiry Wednesday into vaccinations for swine flu made by British pharmaceutical company GlaxoSmithKline, suspected of provoking narcolepsy.
"The MPA has received six reports from health care professionals regarding narcolepsy as suspected adverse drug reaction following Pandemrix flu vaccination," it said in a statement.
"The agency will, in consultation with external experts, assess the possible relationship between the vaccination and the reported reactions."
The reports concern children aged between 12-16 years who developed symptoms compatible with narcolepsy, a chronic sleeping disorder, that occurred one to two months after vaccination against the H1N1 pandemic.
The Medical Products Agency said it was in contact with European Union member states for information on any similar reports in other countries.
Finland is also looking into the possible link between narcolepsy and the swine flu vaccination, in particular Pandemrix, following an increase in the sleeping disorder among children this spring, the Finish news agency STT said.
The preliminary results from the investigation are expected by the end of this year.
In the European Union around 30 million people were vaccinated using Pandemrix. Sweden bought 18 million doses, which was enough to provide two injections for each person in its 9.3 million population.
According to Finland's National Health Institute, 2.5 million Finns were vaccinated against swine flu. Some 750 showed side effects, namely fevers, headaches and coughing, and one case was linked to narcolepsy.
Source: Google News, 19th August 2010.
Risk of Death After H1N1 Vaccine
http://www.journals.uchicago.edu/doi/abs/10.1086/656295
Risk of death after H1N1 vaccine - abstract has been 'removed' from internet, oh I wonder why? It would be great to get a copy of this, my guess is there is a risk of death because there's a disclaimer on there saying the views are not the same as the CDC.
Severe Myopathy in Child After H1N1 Vaccine
Myopathy is a rare complication of influenza infections. Here, we report on an eight-year-old girl with severe myopathy due to new pandemic influenza A (H1N1). She presented with severe myopathy following generalized tonic-clonic seizure and recovered completely within a few days.
Source: Trop Doct 2010;40:242-243
doi:10.1258/td.2010.100024
Swine flu misdiagnosis girl died from natural causes
A Shropshire teenager suffering from tonsillitis who was wrongly diagnosed with swine flu died from natural causes, an inquest has heard.
Charlotte Hartey, from Oswestry, died from complications arising from tonsillitis after being diagnosed with swine flu over the phone last July.
The bacterial infection she had was "highly, highly, highly unusual", pathologist Dr Kenneth Scott said.
The coroner said a correct diagnosis could have meant a different outcome.
Coroner John Ellery recorded a narrative verdict at the inquest in Shrewsbury.
He said he would write to the chief executive of the NHS in Shropshire to ask for a report into the death to be circulated among staff.
'Serious infection'
Shropshire County Primary Care Trust (PCT) has been reviewing the case.
Steve Evans, clinical director at Shrewsbury and Telford Hospitals Trust, said it was a tragic case of a young girl being overwhelmed by a an "extremely rare" bacterial infection.
But accepted there were some aspects of her care that "could have been improved" however and said lessons had been learned from the review into her death.
Dr Scott, who carried out the post-mortem examination, told the inquest on Wednesday that he found no signs of swine flu but confirmed Charlotte died after complications arising from tonsillitis.
The bacteria caused abscesses in her lungs, impairing their function and causing a severe chest infection.
He said the bacterial infection was one he had never come across before.
But he added that "with a correct diagnosis, the correct antibiotics and the correct dosage, given early enough, the outcome could have been different".
Dr Michael Arthur, the GP who prescribed Tamiflu, told the inquest on Wednesday he conducted a phone consultation in accordance with NHS guidelines when swine flu was sweeping the country.
He said Charlotte's symptoms, which included a sore throat, runny nose and persistent cough, were "strongly suggestive" of a virus, rather than an infection.
Two days after Tamiflu was prescribed another doctor visited her at home and agreed with the swine flu diagnosis but also prescribed antibiotics.
He visited her again on 28 July and took a blood test which revealed a high white blood cell count, indicating a serious infection.
By the time she arrived at hospital, Dr Scott said Charlotte was "extremely ill" and it was unlikely she could have been saved.
Source: BBC News Shropshire, 4 November 2010.
Man Dies From Swine Flu Despite Being Vaccinated
A Croatian doctor says a 46-year-old man has died of swine flu even though he had been vaccinated against it.
Dr. Ante Beus, head of the Infective Disease Clinic in Zagreb, says the man the countrys third flu fatality this season did not respond to the vaccine he received a month ago.
People should develop immunity after two weeks.
Beus said Wednesday that the man, who died this week, was obese and had diabetes and several other illnesses, which might have prevented vaccine from working. Doctors are studying the case.
Croatian health authorities urge people to get the shots, but many are reluctant.
More than 20 people died last year in Croatia during the global swine flu outbreak. About 1,000 are believed to be infected now.
Source: The Star.com, 12th January 2011.
VAN UK's Comment: They didn't even consider the possibility that the vaccine may have caused his swine flu.
Grandmother dies from swine flu AFTER she has the jab
A grandmother-of-three thought she was safe from swine flu after she had the vaccine months ago.
But Eleanor Carruthers, 68, from Merseyside became the latest victim of the outbreak on Saturday.
Mrs Carruthers was seriously ill with emphysema and lung cancer, but had had the flu vaccination in October to protect her from the illness.
Despite the step, she was rushed to the Royal Liverpool Hospital last week and later died. H1N1 (swine flu) was recorded as one of the main causes of her death.
She leaves behind three children and her husband Alf, 69. Today her daughter, Carole, 46, said they were all shocked by how quickly her condition deteriorated.
She said: 'What we don't understand is that mum had the vaccine in October, because she was in an at risk group.
Read more: http://www.dailymail.co.uk/health/article-1347171/Swine-flu-Merseyside-Grandmother-Eleanor-Carruthers-dies-AFTER-jab.html#ixzz1BQwhOSQO
There is No Evidence That Flu Vaccines Reduce Complications like Pneumonia or Affect Transmission of the Disease
Vaccines to prevent influenza in healthy adults
Over 200 viruses cause influenza and influenza-like illness which produce the same symptoms (fever, headache, aches and pains, cough and runny noses). Without laboratory tests, doctors cannot tell the two illnesses apart. Both last for days and rarely lead to death or serious illness. At best, vaccines might be effective against only influenza A and B, which represent about 10% of all circulating viruses. Each year, the World Health Organization recommends which viral strains should be included in vaccinations for the forthcoming season.
Authors of this review assessed all trials that compared vaccinated people with unvaccinated people. The combined results of these trials showed that under ideal conditions (vaccine completely matching circulating viral configuration) 33 healthy adults need to be vaccinated to avoid one set of influenza symptoms. In average conditions (partially matching vaccine) 100 people need to be vaccinated to avoid one set of influenza symptoms. Vaccine use did not affect the number of people hospitalised or working days lost but caused one case of Guillian-Barré syndrome (a major neurological condition leading to paralysis) for every one million vaccinations. Fifteen of the 36 trials were funded by vaccine companies and four had no funding declaration. Our results may be an optimistic estimate because company-sponsored influenza vaccines trials tend to produce results favorable to their products and some of the evidence comes from trials carried out in ideal viral circulation and matching conditions and because the harms evidence base is limited..
Source: Jefferson T, Di Pietrantonj C, Rivetti A, Bawazeer GA, Al-Ansary LA, Ferroni E. Vaccines for preventing influenza in healthy adults. Cochrane Database of Systematic Reviews 2010, Issue 7. Art. No.: CD001269. DOI: 10.1002/14651858.CD001269.pub4.
http://onlinelibrary.wiley.com/o/cochrane/clsysrev/articles/CD001269/frame.html
Increased Risk of Narcolepsy After H1N1 Vaccine
Among those 4-19 years of age who received Pandemrix®-vaccine had a manifold increased risk of falling ill with narcolepsy during the 8 months following vaccination in comparison to those unvaccinated in the same age group. Based on the evaluation done so far, the National Narcolepsy Task Force finds it probable that Pandemrix®-vaccination contributed to the observed increase in incidence of narcolepsy among those 4 -19 years of age. Currently, the most likely explanation is that the increase in narcolepsy is by joint effect of the vaccine and some other factor(s). At the moment, there is no evidence that the increase in narcolepsy observed in Finland could be attributed to the vaccine lots used. The results can be read in the Interim Report of the Task Force which is published on February 1st, 2011.
The association of Pandemrix-vaccination and narcolepsy was studied using extensive registry based data. Data gathered from hospital discharge registries on patients fallen ill with narcolepsy during years 2009-10 was linked with data from primary care records on pandemic vaccination. The observed association is so evident that it is unlikely that other so-called confounding factors could fully explain the phenomenon.
Source: National Institute for Health and Welfare - http://www.thl.fi/en_US/web/en/pressrelease?id=24103
Swine Flu Vaccinations for Children Possibly a Mistake
The Chief Medical Officer of Finland's National Public Health Institute has conceded that it may have been unnecessary to vaccinate children and young people against swine flu. Dr Terhi Kilpi told the Väli-Suomi newspaper group's Sunday newspaper supplement that perhaps the vaccine should not have been given to 5-20 year-olds.
Kilpi said that she would no longer recommends the vaccination for this age group. She added that if she had known of the potential consequences, she would have not inoculated 5-20 year-olds.
"A year ago, the current understanding was that the swine flu was a danger specifically for the young. At that time there was not yet any reason to suspect serious side effects to the vaccine," said Kilpi.
The vaccine is now suspected to be linked to an increase in the number of cases of narcolepsy affecting children and young people in Finland, Sweden and Iceland. In Finland, 52 children have been diagnosed with narcolepsy.
Source:http://www.yle.fi/uutiset/news/2011/01/health_official_swine_flu_vaccinations_for_children_possibly_a_mistake_2326931.html
Increased Risk of Narcolepsy after H1N1 Jab
Among those 4-19 years of age who received Pandemrix®-vaccine had a manifold increased risk of falling ill with narcolepsy during the 8 months following vaccination in comparison to those unvaccinated in the same age group. Based on the evaluation done so far, the National Narcolepsy Task Force finds it probable that Pandemrix®-vaccination contributed to the observed increase in incidence of narcolepsy among those 4 -19 years of age. Currently, the most likely explanation is that the increase in narcolepsy is by joint effect of the vaccine and some other factor(s). At the moment, there is no evidence that the increase in narcolepsy observed in Finland could be attributed to the vaccine lots used. The results can be read in the Interim Report of the Task Force which is published on February 1st, 2011.
The association of Pandemrix-vaccination and narcolepsy was studied using extensive registry based data. Data gathered from hospital discharge registries on patients fallen ill with narcolepsy during years 2009-10 was linked with data from primary care records on pandemic vaccination. The observed association is so evident that it is unlikely that other so-called confounding factors could fully explain the phenomenon.
In Finland during years 200910, 60 children and adolescents aged 4-19 years fell ill with narcolepsy. These figures base on data from hospitals and primary care, and the review of individual patient records by a panel of neurologists and sleep researchers. Of those fallen ill, 52 (almost 90 percent) had received Pandemrix® vaccine, while the vaccine coverage in the entire age group was 70 percent. Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 515 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.
In addition to Finland, increase in cases of narcolepsy observed only in Sweden and Iceland
In 2009, among countries using similar pandemic vaccine as was used in Finland, an increase in cases of narcolepsy has been observed only in Finland, Sweden and Iceland. Contrary to the observations in Finland, narcolepsy has occurred in greater numbers than expected also among unvaccinated children and teenagers in Iceland.
The association between narcolepsy and PandemrixR vaccine requires more investigations
During the coming months, these preliminary register based results will be confirmed in Finland. In further investigations, special attention will be given to infections and other stimuli in close time association with the pandemic vaccination. The significance of the possible joint effects will be explored.
In addition, other significant co-factors contributing to the onset of narcolepsy will be evaluated in epidemiologic, immunologic and genetic studies planned. The main aim of the immunologic studies is to clarify, whether the immunological responses to the different components of the Pandemrix® vaccine and to the A(H1N1) virus among those children and teenagers with genetic disposition to narcolepsy and those fallen ill with narcolepsy differ from the immunological responses of other children and teenagers not belonging to these risk groups.
It is also of utmost importance to find out whether the association is observed also elsewhere than in Finland. At present, Finland is participating in the ECDC contracted, VAESO led narcolepsy background incidence and case control studies which are being conducted in 9 European Union countries by pharmacovigilance researchers from Public Health Institutes, Regulatory Agencies and Universities. These studies will evaluate the contribution of the pandemic vaccines and other risk factors in the onset of narcolepsy, and confirm whether increase in incidence in narcolepsy is seen in other countries. The outcomes of these studies will be reported during early summer 2011.
By January 24, 2011, 56 notifications of narcolepsy in association with Pandemrix® vaccination have been received by the National Vaccine Adverse Events Register maintained at the National Institute of Health and Welfare in Finland. Of these, 54 cases belonged to the age group of 419 years. Among most of the notified cases, the onset of symptoms of narcolepsy had started approximately two months following Pandemrix® vaccination.
The final report from the National Narcolepsy Task Force will be released by 31st August 2011.
Source: National Institute for Health and Welfare, 1st February 2011.
Northern Ireland Death Linked to Swine Flu Vaccine
A person has died in Northern Ireland after being given their swine flu vaccination, The Detail can reveal.
The death was reported as a suspected adverse reaction to the H1N1 vaccine sometime between January 1st, 2010 and February 8th, 2011. The report was among hundreds submitted from Northern Ireland to the central government agency responsible for ensuring that medicines and medical devices work and are acceptably safe.
A wide range of side effects suspected to be linked to the swine flu and cervical cancer vaccinations given to teenage girls were reported by healthcare professionals, patients, parents and carers in Northern Ireland to the Medicines and Healthcare products Regulatory Agency (MHRA) during 2009, 2010 and the early weeks of 2011.
The MHRAs Yellow Card Adverse Reaction (ADR) scheme allows health professionals and patients to report suspected adverse drug/vaccine reactions on a voluntary basis and was introduced in 1964 after the Thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. It receives more than 20,000 reports of possible side effects across the UK each year.
The Department for Work and Pensions (DWP) has confirmed that almost £2m has been paid out in compensation to 25 people in Northern Ireland severely disabled by vaccines since 1979.
The MHRA said that it could give no further details on the recent Northern Ireland death including the age of the person or when the death occurred.
Surprisingly, the Department of Health in Northern Ireland claims to hold no information on the fatality and it also confirmed in response to a Freedom of Information request from The Detail that it is not routinely provided with information on adverse reaction reports originating from the province.
The Coroners Service is not investigating the latest vaccine-related death.
Source: The Detail, 21st March 2011, by Kathryn Torney.
Flu Shot Destroys Baby Saba's Life
THIS time last year, Saba Button was a beautiful, thriving 11-month-old. She'd just taken her first three steps, and spoken her first three words. She was perfect in almost every way.
Her mum and dad, Kirsten and Mick, chose to follow the Health Department recommendation and give Saba the flu vaccination.
What they thought was a simple and responsible decision has - in the blink of an eye - destroyed the health and happiness of this very decent family.
Saba had her vaccination at lunchtime, by dinner time she was softly moaning in her cot, with a raging temperature of 40.2 degrees. Life was limping out of her.
Saba then began a desperate fight. After two days in ICU at PMH her family was called in to say goodbye. Kirsten and Mick refused to give up. So did Saba.
She survived but she's now a very different child. Saba has an acquired brain injury from prolonged seizures, it's a global injury, she is no longer able to walk or talk, or eat by mouth.
What makes this story so desperately sad is her parents believe the injury to their daughter could have been prevented.
In the days leading up to Saba's flu jab, 111 other Perth children had suffered adverse reactions.
The Health Department must have known about these terrible outcomes, but didn't issue a warning to parents.
Indeed, while Saba was in ICU clinging to life, nobody in the medical bureaucracy stepped in to stop the program.
So, this wasn't like a car accident that couldn't be avoided. This was a crash where the alarm bells had been ringing for days, if not weeks.
I'd like to know if medical practitioners armed with the knowledge of the adverse reactions were vaccinating their children? Or was it just the innocent deluded public, who trust in their health authorities?
This family's beautiful life has been destroyed. Mick and Kirsten pass in hospital corridors, tag teaming so Saba is never left alone. Their son - Cooper - has lost the tight family unit of a year ago. His sister will never be the same.
I've cried myself to sleep this week, thinking it could have been my family, it could have been yours.
Surely the health department needs to answer a few questions like, when did they know Saba could be at serious risk? Why didn't it pull the program when it was so clear it was going so horribly wrong? And, how can they assure us it will be any different this year?
Source: http://www.optuszoo.com.au/news/top/perth-now/flu-shot-destroys-baby-sabas-life/321294
GPs must return flu vaccine over narcolepsy fears
The Heath Service Executive (HSE) will remove all stocks of the swine flu vaccine Pandemrix from GPs' surgeries, the Sunday Independent has learned.
The vaccine has been linked to the disabling sleep disorder, narcolepsy.
Last week, this newspaper revealed that eight people who received the swine flu vaccine in Ireland have developed the devastating disorder, with most of the cases involving teenagers and young adults.
Now, the HSE has taken the decision to visit GP surgeries around the country and collect the vaccine made by pharmaceutical giant GlaxoSmithKline.
All GPs who received consignments of Pandemrix have been contacted in a letter from Dr Kevin Kelleher, the agency's assistant national director of Population Health and Health Protection.
In the directive, Dr Kelleher states: "I am sure you are aware of reports from Finland and more recently from Sweden regarding a possible association between the use of Pandemrix and the onset of narcolepsy in young people.
"In early January, I advised you that Pandemrix was only recommended if you had a shortage of seasonal flu vaccine.
"As additional stocks of seasonal flu vaccine were delivered to all sites that requested them from the end of January, there has been no requirement to use Pandemrix in any age group.
"Arrangements will be made over the coming weeks to collect stocks of Pandemrix from all general practice sites."
Last week, a new Swedish study found an increased risk of developing narcolepsy among children vaccinated with Pandemrix.
Sweden's Medical Products Agency concluded that those under 20 vaccinated with Pandemrix may be four times as likely to develop narcolepsy than those who did not get the shot.
The Swedish findings by the Lakemedelsverket agency broadly reflect a recent study in Finland, though that investigation found that the risk of children suffering from narcolepsy was nine times higher among those vaccinated with Pandemrix.
Since August 2010, at least 12 countries have reported cases of narcolepsy, particularly among young people.
Last week, the Irish Medicines Board (IMB) said: "The IMB has received a large number of suspected adverse-reaction reports and queries in association with the pandemic influenza vaccines since October 2009, the vast majority of which were consistent with the expected pattern of adverse events for the vaccines.
"Eight reports of narcolepsy-type sleep disorders have been notified in relation to Pandemrix, most of which have been very recently received and are currently being followed up for additional information."
The vaccination of children and adolescents in Finland with Pandemrix was suspended last year until a link to narcolepsy had either been ruled out or detected.
A spokeswoman for the IMB told the Sunday Independent that it was supportive of the latest move by the HSE to remove stocks of Pandemrix from GPs.
In additional information supplied to family doctors, the HSE describes narcolepsy as "a disabling chronic neurological disorder characterised by recurrent episodes of excessive daytime sleepiness."
However, it also noted that narcolepsy is often accompanied by a range of other frightening symptoms including cataplexy -- a sudden loss of muscle tone that is often confused with epilepsy and sometimes leads to a total collapse of the patient.
Other symptoms that can develop gradually include sleep paralysis, and hypnagogic hallucinations -- extremely vivid hallucinations that occur at the boundary between sleeping and waking.
GPs are told in the HSE directive that while there has been an increase in narcolepsy in Finland and Sweden, it has not been noted in all countries using Pandemrix.
"No increase has been seen in the United Kingdom, which also used Pandemrix," the briefing document noted.
The European Centre for Disease Control is undertaking a study in nine European countries, with the results expected by July this year.
"The European Medicines Agency has stated that no definitive conclusions can be drawn until further studies are completed and has therefore not recommended any changes to the marketing authorisation for Pandemrix," it said.
Here, the Health Protection Surveillance Centre will now work with the IMB to examine data available on narcolepsy in Ireland.
"In summary, there has been conflicting data emerging in relation to narcolepsy and the situation is as yet unclear," the HSE told Irish doctors.
Source: Jerome Reilly, Sunday Independent, 3rd April 2011.
H1N1 Vaccine Given To Millions of Britons is Being Withdrawn as it Causes Narcolepsy in Children
A flu vaccine given to millions of Britons as recently as a few months ago will no longer be used after watchdogs found it increased the risk of children developing a serious sleeping disorder.
Pandemrix has been deemed unsuitable for anyone under the age of 20 after studies showed it could trigger narcolepsy a rare disorder which causes a person to fall asleep suddenly and unexpectedly, with potentially dangerous consequences.
The European Medicines Agency advised that the jab should be given to children and teenagers only if other vaccines are unavailable and they still need protecting against the H1N1 swine flu strain.
Read more: http://www.dailymail.co.uk/health/article-2017347/Flu-vaccine-given-millions-Britons-increases-childs-risk-narcolepsy.html#ixzz1Sx3uz9bc
Pandemrix Findings Concern Researchers
The Norwegian Institute of Public Health confirms 23 Norwegians are currently affected by the chronic sleep disorder, 19 of whom are children.
The 2010-11 flu season was marked by 25 cases of H1N1, though most were not diagnosed. Medical personnel were put on alert about a potential new wave of Swine Flu earlier this year, following reports of two suspected cases
According to the authority, Pandemrix has prevented illness and deaths in Norway since it was introduced in 2009 amongst serious concerns for pregnant women.
Nevertheless, six out of ten Norwegians said they did not want to be vaccinated at the time, despite calls by the Institute for people to exercise social responsibility. Many parents in Norway did not participate in the mass vaccination of children.
The Institute issued information about possible side effects, and says today it looks upon reports from Finland, Sweden, and Norway about a possible link between Pandemrix and narcolepsy in children as very serious. Pandemrix was approved across Europe but the vaccine is no longer in use.
Health authorities are cooperating with the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP) to investigate the alleged Pandemrix-narcolepsy connection. Several studies are also being conducted in Norway to chart the situation, according to the Insitute.
Serious adverse effects following vaccination are extremely rare. Rare side effects can only be detected when very many have been vaccinated. This is included in the overall assessment when new vaccines are used, and is also included in patient information, says the Institutes Geir Stene-Larsen.
Source: The Foreigner, 18th July 2011.
Young People Should Not Have Flu Vaccine, Say Watchdog
The European Medicine Agency said that Pandemrix should only be given to the under-20s if they are at risk of contracting swine flu and alternative jabs are not available.
Its announcement comes after studies showed that young people who were given the vaccine were at increased risk of developing narcolepsy, which causes sufferers to fall asleep unexpectedly.
Source: The Telegraph, 21st July 2011 - http://www.telegraph.co.uk/health/swine-flu/8653387/Young-people-should-not-take-flu-vaccine-watchdog-says.html
Finland vows care for narcolepsy kids who had swine flu shot
The Finnish government and major insurance companies announced Wednesday they will pay for lifetime medical care for children diagnosed with narcolepsy after receiving the swine flu vaccine.
"The compensation will provide much-needed financial assistance for the families, although it cannot take away the emotional distress caused by this condition," Social Services and Health Minister Paula Risikko said in a statement.
Finnish and international researchers recently found a conclusive link between the Pandemrix swine flu vaccine and new cases of narcolepsy, a chronic nervous system disorder which causes people to often uncontrollably fall asleep.
The Finnish Pharmaceutical Insurance Pool (LVP), which represents insurance companies, said Wednesday it would honour all insurance claims in this category.
LVP said it would review each claim individually to calculate the scope of the payout.
The Finnish government meanwhile agreed to cover any medical costs exceeding the insurance claims.
In Finland, 79 children between the ages of four and 19 developed narcolepsy after receiving the Pandemrix vaccine in 2009 and 2010.
Of these cases, an unusually high number, 76, also suffered from bouts of cataplexy, suffering hallucinations or paralysing physical collapses, according to Finnish research.
Source: Google News, 5th October 2011.
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