Before you vaccinate ask:
- Does my child really need this vaccination?
- Is my child well enough to have this vaccine?
- Has my child had a bad reaction to a vaccination before?
- Does my child or family have a history of:
Vaccine reactions? Convulsions? Neurological disorders?
Allergies (asthma, antibiotics)? Immune system problems? - Do I have full information on the vaccine's side effects?
- Do I know how to identify a vaccine reaction?
- Do I know how and why my doctor should report a vaccine reaction?
- Do I know the vaccine's name and batch number?
- Do I know what chemicals and biological agents are in the vaccine?
- Make informed vaccine decisions and help prevent vaccine reactions!
Cervarix HPV Summary of Product Characteristics
http://www.medicines.org.uk/emc/medicine/20204/SPC/Cervarix
GSK Cervarix HPV Product Information Leaflet
Merck's Gardasil HPV Product Information Leaflet
https://www.merckvaccines.com/Products/Gardasil9
UK's Medicines and Healthcare products Regulatory Agency (MHRA)
The “Suspected Adverse Reaction Analysis” on the CERVARIX Human papillomavirus (HPV) vaccine, updated by the UK MHRA on 1st July 2010, outlines 4,445 reports and 9,673 suspected reactions. The details are summarised here in the link below:
News Articles
US National Vaccine Information Center: Human Papillomavirus (HPV) Vaccines and disease
http://www.nvic.org/Vaccines-and-Diseases/HPV.aspx
The New England Journal of Medicine
http://www.nejm.org/doi/full/10.1056/NEJMe0804638
Human Papillomavirus Vaccination — Reasons for Caution
N Engl J Med 2008; 359:861-862August 21, 2008DOI: 10.1056/NEJMe0804638
Parliamentary debate raised by Crispin Blunt MP, Reigate 13th May 2009
http://www.publications.parliament.uk/pa/cm200809/cmhansrd/cm090513/debtext/90513-0024.htm
Daily Mail, 5th April 2009: How safe is the cervical cancer jab? Five teenagers reveal their alarming stories
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Letter from a parent to all secondary schools in Scotland & England [HPV vaccine]
Message from JABS: the mother who wrote this letter has now sent it to all schools in Scotland and England. If you have concerns about HPV vaccine it could be useful to contact your school to reinforce the points raised: Headteacher, PTA, Governors.
September 2017
Dear Sir/Madam
With regards to the Human Papillomavirus Vaccination administered in your school, I would like to raise your awareness to the real possible side effects of this vaccine, as well as the lack of studies and safety tests actually carried out on this Vaccine.
To make it clear, I am writing this letter from the stance of a mother whose perfectly healthy (apart from slight hayfever) daughter’s life was completely altered after receiving Gardasil.
Very soon after receiving her first vaccination, her health started to decline, both mentally and physically, for what appeared to be no reason. To cut a very lengthy story short, she has suffered over the past five years with the following conditions: Fainting Spells/Dizziness Irregular Heartbeat and Increased Heart Rate Shortness of Breath Complete Loss of Appetite Light Sensitivity Extreme Fatigue/Irregular Sleeping Patterns Depression Inability to Stand/Walk for any period of time Severe Social Anxiety Numbness of Lower Legs/Feet Constant Headaches Brain fog/cognitive impairment Inability to regulate body temperature General Feelings of Malaise Please note that she never experienced any of these symptoms until October 2012, which is when she received the first vaccine.
You might look at this and think she must have had something underlying or she’s a rare case, but please be assured that I have been and still am researching this extensively. There are at least 472 once healthy girls in the UK alone that have reported severe side effects similar and sometimes worse to those outlined above after being administered the HPV Vaccine. There have been fatalities – even a Spanish court ruled it the cause of a young girl’s death earlier this year.
You may also look at it and think plenty of girls are fine after receiving the vaccine; this may be true, but then again plenty of people can take Penicillin whereas to others it can be deadly. Put it this way, if you had a student with a severe nut allergy, you would do everything in your power to ensure that child was not put at risk, wouldn’t you? Imagine you were in a position where you have been trapped with 15 students for days, you are all starving, suddenly someone finds a large chocolate bar containing nuts. You have been told one of the students, though you are unsure which one (and no-one is admitting it is them), might have a nut allergy, would you give them all a piece of the chocolate on the off chance none of them had the allergy? Yet you are allowing nurses to come into your school, give out minimal information regarding side effects, which is leaving families to make uninformed decisions and unwittingly put their girl in harm’s way, without any sort of background health checks.
You may think it’s worth the risk if it’s going to save girls from cervical cancer, but please consider the following points:
1) The HPV Vaccine has not been proven to cure or prevent cancer, it is thought it may prevent 9 strains of the virus, however there are over 100 strains.
2) It is not the only option, earlier PAP Smears (from the time the individual is sexually active) would lead to early detection, monitoring and treatment in the event of any irregular cells.
If you look back over the 8 years since the HPV Vaccine began being administered, can you think of any situation where a perfectly healthy young girl suddenly started experiencing ill health or not being able to attend school for no apparent reason? Maybe you can’t directly remember yourself, but another staff member might.
That is what happened with my daughter, as well as a number of the girls I have come into contact with through the UK Association of HPV Vaccine Injured Daughters. I was not given the full insert leaflet for Gardasil; instead I was given the advice that it may cause minor side effects that would last a couple of days at the most.
I am aware that this is a programme that is rolled out all over the UK, but please, I urge you to investigate this for yourself and read some case studies which can be found here. (Please google Sanevax.org if you are apprehensive about following this link.) If you come to the conclusion that there is the potential that this vaccine could be causing harm to some girls, please speak to your Education Boards, your students’ parents and anyone else who will listen. This is so, so important and could save lives. The supposed benefit does not outweigh the risk, one child harmed by this is one child too many.
I appreciate your taking the time to read my letter and I hope that you have done so with an open mind. I was never anti-vaccine, otherwise my daughter would not be in the situation she is now (wheelchair bound and practically housebound). I will forever regret not researching this product thoroughly before allowing it to be injected into her; please don’t allow others to feel the same regret. Kindest Regards
Mrs D
Mother of a Vaccine Injured Daughter
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JABS UK HPV Vaccination Briefing Note - October 2017
1. INTRODUCTION
The Joint Committee on Vaccination and Immunisation (JCVI) was notified of new HPV vaccines that were in development in June 2005 and then considered HPV vaccines on seven separate occasions.
The JCVI considered the evidence on vaccine efficacy and safety for both vaccines based on clinical trial data and post-marketing surveillance reports (see more in 5,6 below); this data is summarised in the specific product information for both vaccines. In addition, JCVI considered a document outlining the safety of Cervarix® and Gardasil® from the manufacturers’ clinical trials; the document detailed a presentation to the EMEA from the Global Advisory Committee on Vaccine Safety which reviewed the same material.
The evidence presented led the committee to confirm that a universal HPV vaccination programme for girls aged 12 to 13 years would be cost effective. In addition, the committee also recommended a catch up vaccination of girls aged 13 to 17 years to be delivered through schools.
2. HPV VACCINATION IS INTRODUCED INTO UK VACCINATION SCHEDULE IN 2008
St. Monica's RC High School in Prestwich, Greater Manchester was involved in the pilot study of the HPV vaccine. When the Department of Health (DH) decided to roll out the vaccination programme across all schools the governors of St Monica's wrote to parents outlining their concerns about the vaccine. They had no moral objection to the vaccine but stated that a number of the school's pupils who took part in the pilot study were subsequently off school suffering from nausea, joint pain, headaches and high fevers. The letter stated that they did not believe that school was the right place for the injections to be administered, therefore governors had taken the decision not to allow the school premises to be used for this programme.
3. THE JABS GROUP STARTS TO RECEIVE CALLS FROM WORRIED PARENTS ABOUT HPV VACCINES
Shortly after the campaign began in September 2008 JABS started to receive phone calls from concerned parents. They told us that their previously fit and healthy daughters had suffered immediate health problems following the vaccinations, some resulting in hospitalisation, and had then developed long-term serious ill-health.
We asked each family if their daughter’s doctor or consultant had reported the symptoms and change in the girl to the UK's Medicines Healthcare product Regulatory Agency (MHRA) using the adverse events surveillance mechanism known as the ‘yellow card’ scheme. The vast majority responded that the health professional had declined to use the reporting system as he/she had dismissed any link with the vaccination as ‘just a coincidence’. Therefore, the suspected reactions had not been put forward to the monitoring body for investigation.
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4. DRUG MANUFACTURERS' PRODUCT INFORMATION
The two drug manufacturers of HPV vaccines, GSK (Cervarix) and Merck (Gardasil), have provided the Government’s vaccine policy makers with product sheets which list the adverse reactions known to be associated with their vaccines. Gardasil HPV vaccines replaced Cervarix HPV vaccines in the UK from September 2012.
The MHRA had received reports of suspected adverse reactions. In answer to a parliamentary question the Countess of Mar was informed that up to July 2015 8 million doses of HPV vaccines had been given across the UK, Cervarix reported adverse reactions equalled 6,266, Gardasil reported adverse reactions equalled 1,471 and another 507 reports did not specify which HPV brand had been used. Given that it is accepted that there is a 95% underreporting of adverse reactions these figures are probably not accurate.
5. PRE-LICENSURE SAFETY OF VACCINES
All drugs licensed by the UK’s MHRA undergo long-term double-blind pre-licensure clinical trials during which the rate of adverse reactions in the group receiving the drug under review is compared to the rate of adverse reactions in a group receiving an inert placebo, such as a sugar pill or saline injection.
In contrast, vaccines in general are not required to undergo long-term double-blind inert-placebo controlled trials to assess safety. Further, most paediatric vaccines currently in use in the UK have been approved based on studies with inadequate follow-up periods of only a few days or weeks. The real vaccine trials begin when the vaccines are rolled out over the population.
6. POST- LICENSURE ADVERSE EVENT SURVEILLANCE SYSTEM: YELLOW CARD
The lack of pre-licensure safety data leaves the assessment of vaccine safety to the post-licensing period when they are being administered to children on a routine basis. In theory the system should work to flag up any serious problems with drug products - the guidelines advise that all suspected reactions should be reported. In practice the system was and still is largely ineffective because health professionals make their own arbitrary decisions on whether to report the serious suspected side effects of vaccinations. The DH does not enforce the collection of any reliable data on adverse events. Currently the reporting system only collects about 5% to 10% of serious adverse reactions which does not make reliable data on which to determine the safety of any vaccine.
It would be far better if treating physicians reported all suspected adverse reactions instead of making their own on-the-spot judgement this would help to avoid the problems of under-reporting. All reported suspected adverse reactions should be routinely followed-up by the MHRA making contact with the doctor and reviewing each report with the doctor several months later to ensure the individual has fully recovered or to assess further. This could provide invaluable information and help to clarify which vaccines might cause harm and to whom, potentially avoiding future injuries and deaths.
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The Health Protection Agency in its former role as Public Health Laboratory's Service is on record in the Lancet (Vol. 345. March 4, 1995) stating ''....there is an urgent need to find more reliable methods of adverse event surveillance.'' The point being that unless all reactions are put forward to a central body instead of being dismissed as 'unrelated' or ‘just a coincidence' the central database will never hold accurate information on adverse events.
7. RESPONSIBILITY FOR VACCINE SAFETY
The first step in assuring safer vaccines is to identify what harms they cause. This would normally be accomplished pre-licensure by long-term, inert-placebo controlled trials – but these are never performed for vaccines.
The JCVI is the body charged by the DH to make recommendations to the Health Minister for new vaccines and changes to the vaccination programme. The JCVI appears to rely on the pharmaceutical vaccine trials which are too short, involving too few recipients that have been selected for their good health and fitness. When the JCVI recommends a new vaccine or schedule it is rolled out across the target population which will not take into account an individual’s personal health.
As for post-licensure monitoring, the MHRA has failed to improve the Yellow Card scheme to ensure accurate adverse event reporting. The limited number of reports they do receive are not investigated thoroughly and followed up with the reporting doctor. Hence, assessing which vaccines cause which injuries is based on inaccurate and insufficient data which has been clearly neglected by the DH and MHRA.
Richard Ley, of the Association of British Pharmaceutical Industries said in the Daily Express (May 18, 2000): ‘The Government implemented the vaccination programme knowing in full detail what the possible side-effects were. They knew what they were taking on, the damage is therefore their responsibility and they should compensate people accordingly.’
8. IDENTIFYING THOSE SUSCEPTIBLE TO VACCINE DAMAGE
It is commonly stated by medical authorities that there is individual susceptibility to serious vaccine adverse reactions. The research must be done on an individual basis: considering personal medical history, current state of health, personal genome and other environmental factors. Currently there is no pre-vaccination assessment to ensure the vaccine is safe for the individual. There should be urgent action taken by the DH to determine the factors which put individuals at risk. The one-size-fits-all policy is unsafe and unacceptable and contravenes the European Parliament’s 2001/20/EC Directive:
DIRECTIVE 2001/20/EC OF THE EUROPEAN PARLIAMENT
AND OF THE COUNCIL of 4 April 2001
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…on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use…
…However, there is a need for clinical trials involving children to improve the treatment available to them. Children represent a vulnerable population with developmental, physiological and psychological differences from adults, which make age and development related research important for their benefit. Medicinal products, including vaccines, for children need to be tested scientifically before wide-spread use. This can only be achieved by ensuring that medicinal products which are likely to be of significant clinical value for children are fully studied. The clinical trials required for this purpose should be carried out under conditions affording the best possible protection for the subjects. Criteria for the protection of children in clinical trials therefore need to be laid down…
9. VACCINE DAMAGE PAYMENT ACT 1979
The Government is well aware that vaccines can cause severe damage or death; there is a branch of the Department of Works and Pensions known as the Vaccine Damage Payment Unit (VDPU). It was set up following the Vaccine Damage Payment Act 1979.
The VDPU is effectively the only way for a UK parent to obtain an "award" for a child's vaccine injury. The parent has to make a claim to a vaccine damage tribunal in a quasi-judicial process chaired by a barrister and two medical experts who sit in judgement of any claim. The parent has to show that the degree of disability exceeds 60% and the disability was caused, on the balance of probabilities, by the vaccine. The parent must provide medical reports to explain the biological mechanism by which the vaccine injured the child.
Requiring parents to prove causation adds insult to injury because had the DH conducted the vaccine safety science it demands as proof in the VDPU tribunal before licensing a vaccine, the young person’s injury may have been avoided altogether. It is no surprise that most claims face a high likelihood of failure at VDPU tribunals.
If the parent is successful the 'award' is limited to a one-off payment of £120,000.
10. UK EXPERIENCE
In July 2015 information provided by the MHRA revealed there had been 8,228 reports of HPV vaccine suspected adverse events of which 2,587 were classified as ‘serious’. Parents who had contacted JABS reported chronic fatigue/ME syndromes, blackouts, paralysis, vision problems, joint pain, arthralgia, seizures. (1)
11. JAPANESE EXPERIENCE
On 13th February 2017 in Tokyo, Japan, a law suit opened in court over cervical cancer vaccine side effects involving 28 girls and women. The side effects reported covered a wide range of health problems which included pain all over their bodies and impaired mobility. (2)
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12. IRISH EXPERIENCE
On 12th September 2017 the Irish Health Products Regulatory Authority stated it had received 1,099 reports of adverse reactions and events associated with HPV vaccines. Of those considered serious, 648 cases required medical intervention and treatment. Some of the reports included persisting chronic fatigue generally with multiple other symptoms e.g. joint swelling, gastrointestinal upset, menstrual disorders, syncope. (3)
13. DANISH EXPERIENCE
A report from the Danish health authorities shows that from 2009 to the middle of 2015, 1,589 girls have reported side-effects from the HPV vaccine. The report estimates that 543 have had serious side-effects. (4)
14. COLOMBIAN EXPERIENCE
On 4th August 2017 in Colombia a class action law suit was filed against the Colombian government and Merck Sharp & Dohme by a group representing 700 individuals who alleged that they had been damaged by Gardasil HPV vaccines. Symptoms reported mainly affect the immune and neurologic systems. The group is also calling for a declaration that the vaccine is unsafe. (5)
15. US EXPERIENCE
The US Vaccine Adverse Event Reporting System as of 31st December 2016 listed a total of 43,532 vaccine reaction reports associated with Gardasil vaccinations, including 250 deaths. (6)
16. CANADIAN EXPERIENCE
Adverse events following HPV vaccination in Alberta between 2006 and 2014 were reported. The number of reports stated 19,351 females had an emergency department visit within 42 days of immunisation, 958 were hospitalised. (7)
17. CONFLICTS OF INTEREST
The DH in the UK, unfortunately, is in charge of two competing duties. On one hand, the DH is responsible for vaccine safety. On the other hand, the DH is responsible for promoting vaccine uptake and also defending against any claim of vaccine damage.
Regrettably, it appears that the DH has chosen to focus almost entirely on its vaccine promotion and defence function to such a degree that it has essentially abandoned its vaccine safety responsibility. To restore balance, the DH must take serious steps to create an “ethics firewall” between these competing functions. The DH must also take action with regard to the JCVI and those in the MHRA committee members/employees that have direct and indirect conflicts of interest with vaccine manufacturers.
18. WORLD HEALTH ORGANISATION (WHO) - CAUSALITY OF ADVERSE EVENTS
“Since the inception of vaccination, it has been recognised that adverse events following immunisation will occur.”
The WHO gives criteria to be considered when an adverse event is reported:
i. CONSISTENCY
The association of a purported adverse event with the administration of a vaccine should be consistent, i.e. the findings should be replicable in different localities, by different investigators not unduly influencing one another, and by different methods of investigation, all leading to the same conclusion(s).
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ii. STRENGTH OF THE ASSOCIATION
The association should be strong in the magnitude of the association (in an epidemiological sense), and in the dose-response relationship of the vaccine with the adverse effect.
iii. SPECIFICITY
The association should be distinctive and the adverse event should be linked uniquely or specifically with the vaccine concerned, rather than its occurring frequently, spontaneously or commonly in association with other external stimuli or conditions.
iv. TEMPORAL RELATION
There should be a clear temporal relationship between the vaccine and the adverse event, in that receipt of the vaccine should precede the earliest manifestation of the event or a clear exacerbation of an ongoing condition. For example, an anaphylactic reaction seconds or minutes following immunisation would be strongly suggestive of causality; such a reaction several weeks after vaccination would be less plausible evidence of a causal relation.
v. BIOLOGICAL PLAUSIBILITY
The association should be coherent; that is, plausible and explicable biologically according to known facts in the natural history and biology of the disease.
The WHO continues with:
a. The requirement for biological plausibility should not unduly influence negatively a consideration of causality. Biological plausibility is a less robust criterion than the others described. If an adverse event does not fit into known facts and the preconceived understanding of the adverse event or the vaccine under consideration, it clearly does not necessarily follow that new or hitherto unexpected events are improbable. Biological plausibility is most helpful when it is positive; it is less so when negative.
This is an important statement as it makes it quite clear that just because something has not been recognised as linked with the vaccine in the past doesn’t mean it isn’t linked. This supports our concern that with the failure of the post-vaccination adverse event surveillance system to collect data on unexpected reactions and therefore a failure to investigate them could be allowing a serious problem to go undetected.
This could lead to a catch 22 system; because the problem hasn’t been linked with HPV vaccine before, further reports of the same problem are not put forward because they are not known to be linked with the HPV vaccine.
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b. Consideration of whether the vaccine is serving as a trigger (trigger in this context is an agent that causes an event to happen which would have happened some time later anyway). When acting as a trigger, the vaccine may expose an underlying or pre-existing condition or illness. An example of the latter would be an auto-immune condition triggered non-specifically by the immune stimulus of the vaccine.
This is an interesting point. Many of the parents report that their daughter’s health problems are not known in the family’s medical history but they have been told by their medical practitioner that the vaccine acted as a trigger to reveal the underlying condition.
19. EUROPEAN COURT OF JUSTICE - RULING
In June 2017 it was reported that the European Court of Justice has ruled that a vaccine can be considered defective - and thus the cause of a disease - if there is "specific and consistent evidence" related to when the vaccine was administered, the patient's previous state of health, the lack of family history of the disease, and a significant number of reported cases of the disease occurring following vaccination.
The court went on to state that such factors could lead a court to determine that "the administering of the vaccine is the most plausible explanation" for the disease, and that "the vaccine therefore does not offer the safety that one is entitled to expect,”. (8)
20. SUMMARY
The UK government, through the DH, MHRA and JCVI licenses and promotes vaccines to a childhood population with very limited safety data and actively defends against any claim that vaccines cause harm. There is no other drug product where the very government department responsible for the safety and regulation of that product so enthusiastically promotes its uptake whilst simultaneously defends the damage and death that product causes.
A Parliamentary Health Select Committee would be well placed to address parents’ concerns.
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ACKNOWLEDGEMENTS
With grateful thanks to Del Bigtree and colleagues at ICAN
REFERENCES
(1) http://www.independent.co.uk/life-style/health-and-families/thousands-of-teenage-girls-report-feeling-seriously-ill-after-routine-school-cancer-vaccination-10286876.html Thousands of teenage girls report feeling seriously ill after routine school cancer vaccination.
(2) https://www.japantimes.co.jp/news/2017/02/13/national/crime-legal/suit-opens-tokyo-court-cervical-cancer-vaccine-side-effects/#.We0ldEyZNBw Suit opens in Tokyo court over cervical cancer vaccine side effects.
(3) https://www.irishtimes.com/news/health/almost-650-girls-needed-medical-intervention-after-hpv-vaccine-1.3217346 Almost 650 girls needed medical intervention after HPV vaccine
(4) http://cphpost.dk/news/side-effects-stories-affecting-hpv-vaccination-numbers.html Side effect stories affecting HPV vaccination numbers
(5) https://www.medscape.com/viewarticle/883873 Class Action Lawsuit Against HPV Filed in Colombia
(6) http://www.medalerts.org/vaersdb/findfield.php
(7) https://www.ncbi.nlm.nih.gov/pubmed/26921782 Adverse events following HPV vaccination, Alberta 2006-2014.
(8) https://www.rt.com/news/393492-eu-court-vaccinations-ruling/ Vaccines can be blamed for diseases without any proof, EU top court rules
CONTACT DETAILS:
01942 713565
jackie@jabs.org.uk
Facebook: JABS: Justice, Awareness & Basic Support
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