Open Letter from International Organisations to the WHO on the Issue of Vaccine Safety

by European Forum for Vaccine Vigilance

To the World Health Organisation and those attending the meeting of the Global Vaccine Quality Control Laboratories Network (Rome 25th-27^th September 2018).

To the European Parliament, the European Medicines Agency and the European Directorate for the Quality of Medicines

Dear members of the World Health Organisation,

By sharing science and joining efforts towards better health, your organisation has improved the lives of millions of people, and we are grateful for this. Providing better nutrition, clean water, improved hygiene, and access to medical care, mortality and infectious disease have been drastically reduced. Your extraordinary communication campaign to detect cases of disease and their contacts, and isolate them, finally led to the eradication of the once devastating smallpox.¹ These are great achievements and these noble goals should be further pursued.  Today however, we are facing a new epidemic: chronic disease.  In the USA, one in two adults has a chronic disease and one in four has two or more. ²

Obesity, asthma, cancer, immune and autoimmune diseases, neurological and developmental disorders, are ‘lifestyle diseases’ mainly caused or aggravated by bad nutrition and toxic load. Vaccines are administered to healthy individuals to prevent targeted infections, but their long-term impact on the immune system and their potential role in chronic disease is not being evaluated. Individual risk of poor outcomes to both infection and vaccination varies widely and mass vaccination without proper discrimination at the individual level has led to injuries, death and unintended consequences. Recently, independent researchers and laboratories have discovered that many vaccines are contaminated with retroviruses³ and polluted by nanoparticles ⁴. High levels of aluminium associated with vaccine adjuvants have been found in the brains of autistic children or in people suffering from neurological disorders such as Alzheimer’s disease.^{5, 6}

In your previous meeting you advocated for less independent testing, considered ‘redundant’, in order to speed up the supply of products.⁷ The recent administration of 250,000 defective vaccines in China⁸, the tragedy of the oral polio campaign in India with over 450,000 cases of paralysis and death⁹, the damage caused by the Dengue vaccine in the Philippines¹⁰, reports from all over the world of chronic pain and paralysis after administration of the HPV vaccine^{11, 12,}  show that vaccine safety and efficacy are being tragically disregarded in this drive for fast-tracking approval and easy certification.

If developing standards and sharing best practice amongst controlling bodies is needed, testing by national and independent laboratories must be maintained, since fraud and technical hazard from storage or transportation can still occur and biases or new findings would not be detected.  According to your report, «It was noted that the aims of the network are a good fit with industry’s proposal for risk-based testing and networking».¹³ But this ‘risk-based’ approach geared to reducing test requirements for vaccines considered of ‘low risk’, seems a dangerous pursuit.

Many health authorities complain about vaccine hesitancy, but fail to reassure the public by providing the safety data they request.  All over the world, millions of people have signed petitions demanding more safety, transparency and independent research, but decision makers chose fast-tracking instead.

To restore confidence lost, we insist that before any kind of recommendation or authorisation is issued, ALL vaccines pre-qualified or recommended by the WHO will be submitted to:

• Extensive clinical trials conducted by bodies independent from the manufacturers
• Medium- and long-term studies on efficiency and safety, not ‘days’.
• Tests for carcinogenic properties
• Tests around fertility issues
• Tests on pregnancy, spontaneous abortion and the developing foetus
• Tests for mutagenic effects (changes induced in the DNA)
• Tests for effects on the neurological system and development of the brain
• Real inert placebo testing, which is almost never conducted on vaccines

We also insist that the WHO should provide studies on:

• Adjuvants and preservatives such as aluminium and mercury and their bioaccumulation
• Other toxic material used, such as polysorbate, Tween 80, formaldehyde etc
• Vaccine safety and the age of vaccine administration
• The impact of full vaccine schedules on the global health of a population
• The comparison of vaccinated versus unvaccinated populations in global health terms
• Viral transmission of people recently vaccinated with live virus vaccine such as measles, mumps, rubella, varicella, influenza or oral polio vaccine for example.

In particular, we ask that the use of combined vaccines and the same-day administration of multiple vaccines be thoroughly investigated.  Figures from India show that the number of deaths within three days following vaccination doubled when using a Pentavalent (5-in-one) vaccine rather than a triple DTP vaccine. It is projected that this change will cause between 7,020 and 8,190 deaths each year in infants in India¹⁴. It further appears that in confidential periodic safety reports of the hexavalent Infanrix polio vaccine submitted to the EMA, the manufacturer GSK had deleted a number of death cases between reports. ¹⁵

Concerning the measles-mumps-rubella vaccine and its link with autism, the only reference mentioned on the autism section of your website is an out-dated French article translating press claims that have been disproven in a decision from the English High Court in 2012. ^{16, 17} At the same time, William Thompson, an expert from the CDC, confessed in 2014 to having manipulated the data of a key reference study but as of present date, no further investigations have been made.¹⁸With one in 36 children diagnosed with an Autistic Spectrum Disorder in the USA¹⁹, this study is an absolute priority and independent laboratory testing and new clinical trials must now replace the flow of ‘inconclusive’ statistics.

Confirming this priority, an Italian Parliamentary Commission recently reported numerous deaths, autoimmune diseases and cancers in military personnel after multiple vaccines had been administered and called for more research and precautionary measures²⁰. The long-term effects of vaccines are not studied and the recent revision of the classification of “Adverse Events Following Immunisation” does not allow for accurate reporting of death cases or of side effects not previously declared by the manufacturer.²¹ With the alarming rise in chronic diseases, immune, autoimmune and developmental disorders worldwide, immediate responsible action is imperative.

In its recent resolution on vaccine hesitancy, the European Parliament calls for “transparency and declaration of conflicts of interest, including researchers working for the World Health Organisation and the European Medicines Agency”. It proposes that “researchers subject to a conflict of interest be excluded from evaluation panels”; further calls for “the confidentiality of the deliberations of the EMA evaluation panel to be lifted” and proposes that “the scientific and clinical data which inform the conclusions of the panel, and whose anonymity is guaranteed in advance, be made public”. ²²

It fails however to question biased reports. ²³

When it comes to approving or recommending a new vaccine, we know that:

• Pre-licensure studies are exclusively carried out by the manufacturers who stand to profit.This is a clear conflict of interest.
• Pre-licensure studies do not and cannot capture all adverse events that will occur in real world situations.
• Peer reviewed scientific journals have huge conflicts of interest and most studies are biased or false ^{24, 25, 26}
• Post-marketing surveillance in all countries is woefully inadequate. Only 1 to 10% of adverse events are being reported. In the USA, the mandatory biennial safety reports from US Health & Human Services to Congress on vaccine safety have simply never been written. ²⁷

The funding of your organisation relies on important private donations, such as the GAVI alliance, a partnership with banks and industries. The fact alone that this very meeting is funded by a private investor, the Bill and Melinda Gates Foundation²⁸, is highly questionable.  Given this inherent conflict of interest, it is therefore absolutely imperative that independent studies and experts be involved in the approval and recommendation of vaccines and vaccine policies.  And if the WHO guarantees the safety of the vaccine it is pre-qualifying, it should also assume liability for adverse events following vaccination.

Promoting mandatory vaccination for entire populations with products that essentially rely on manufacturers’ data for their general safety and efficacy is an evident breach of the precautionary principle and as such becomes a forced medical experiment.

Since the health risk of vaccination is entirely borne by individuals, the WHO must ensure that it is minimal, and that fully informed consent is observed.

In order to restore public trust in health authorities and improve public health policies worldwide, we therefore demand actions and answers that meet our requests.

We thank the honorable members of this assembly for their attention and pray they will open their hearts and minds to our message.

Read the full letter at EFVV.eu.

Comment on this article at VaccineImpact.com.

References:

1. «The Global Eradication of Polio» Final Report of the Global Commission for the Certification of Smallpox Eradication, Geneva, December 1979, the World Health Organization, 1980.

2.  «About Chronic Disease», Centres for Disease Control and Prevention, 5 September 2018

3.  J. Mikovits & K. Heckenlively «Plague», Skyhorse Publishing, 2014

4.  S. Montanari, A. Gatti «New Control Investigations on Vaccines : Micro- and Nanocontamination», International Journal of Vaccines and Vaccination, Vol. 4 Issue 1, 23 Jan. 2017

5.  C. Exley et al., «Aluminium in Brain Tissue in Autism», Journal of Trace elements in Medical Biology, March 2018, 46 :76-82

6.  C. Exley, «Aluminium and Alzheimer’s Disease: The Science that Describes the Link. Elsevier Science», Amsterdam, The Netherlands. 2001. 441p

7.  Report of the First General Meeting of the WHO-NCL Network for Biologicals, Noida, India, 31 Oct.-2 Nov.2017.

8.  F. Murphy «China Vaccine Scandal : Investigations Begin into Faulty Rabies and DTaP shots» British Medical Journal, 25 Jul. 2018, 2018 ; 362 ;k3244

9.  Rachana Dhiman , Sandeep C. Prakash, V. Sreenivas , Jacob Puliyel. Correlation between Non-Polio Acute Flaccid Paralysis Rates with Pulse Polio Frequency in India Int J Environ res Public Health 2018;15:1755

10.  P. Rana«Initial Philippines Probes Finds Causal Association Between Deaths and Sanofi Dengue Vaccine», Wall Street Journal, 2 Feb. 2018

11.  P. Goetzsche et al. «Complaint filed to EMA over Maladministration Related to the Safety of the HPV Vaccine», Nordic Cochrane

12.  R. Gherardi «Toxic Story», Actes Sud, Oct. 2016

13.  Report of the First General Meeting of the WHO-NCL Network for Biologicals, Noida, India, 31 Oct.-2 Nov.2017, p. 6, section 3.4

14. J. Puliyel, Jaspreet Kaur, Ashish Puliyel, Visnubhatla Sreenivas «Deaths Reported after Pentavalent Vaccine Compared with Death Reported after Diphtheria‑Tetanus‑Pertussis Vaccine: An Exploratory Analysis.» Med J DY Patil Vidyapeeth 2018;11:99-105.

15.  J. Puliyel, SathyamalaC. «Infanrix hexa and sudden death: a review of the periodic safety update reports submitted to the European Medicines Agency», Indian Journal of Medical Ethics 2018 Jan-Mar;3(1):43-47

16. High Court Decision of 7 March 2012, between Prof. John Walker-Smith and the General Medical Council, EWHC 503, Case n° CO/7039/2010

17. V. Sharav «L’Affaire Wakefield : Shades of Dreyfus and BMJ’s Descent Into Tabloid Science», Alliance for Human Research Protection, 2017

18. Documentary «Vaxxed : from Cover-Up to Catastrophy» April 2016.

19. B. ZAblotsky et al. «Estimated Prevalence of Children Diagnosed with Developmental Disabilities in the United States, 2014-2106» NCHS Data Brief n°291, November 2017

20. “Parliamentary Commission of Inquiry into Cases of Death and Severe Illnesses Affecting Italian Personnel Assigned to Military Missions Abroad”, Acts of Parliament, XXII-bisn. 23-bis,Vol. I, II and III , Rapporteur G. P. Scanu, Approved 7 Feb. 2018

21. Puliyel J, Naik P  Revised World Health Organization (WHO)’s causality assessment of adverse events following immunization—a critique https://f1000research.com/articles/7-243/v2

22. «Vaccine Hesitancy and the drop of Vaccination Rates in Europe», resolution of the European Parliament, 19 April 2018. (2017/2951)

23. L. Jorgensen, P. Goetzsche, T. Jefferson «The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias» BMJ evidence Based Medicine, July 27th 2018.

24. P. Goetzsche, «A moral governance crisis : the growing lack of democratic collaboration and scientific pluralism in Cochrane», open letter 14 Sep. 2018, Nordic Cochrane Centre

25. J. Ioannidis, «Why Most Published Research Findings are False», PLOS medicine, 30 Aug. 2005

26. M. Angell «The Truth about Pharmaceutical Companies.  How They Deceive Us and what to do About It», Random House, 2004

27. «Mandate for Safer Childhood Vaccines», Decision of the US District Court, Southern District New York, Between Informed Consent Action Network and the US Department of Health and Human Services

28. The Bill & Melinda Gates foundation is one the 5 biggest investors in the world. In August 2018, it had 22,114 million $ in stocks according to gurufocus.com

FRANCE

Françoise Joët, co-founder of both Association Liberté Information Santé
(ALIS) and the European Forum for Vaccine Vigilance (EFVV) *
Sophie Guillot for Agir pour le Libre Consentement Thérapeutique, France
Sophie Guillot, Ensemble pour une Vaccination Libre, France
Marie Werbrègue, Info Vaccin France
Lucie Michel, Les Mamans Courage, France
Marie-Rose Cuisigniez, Association Liberté Information Santé, France
Patrick Ledrappier, Libre Consentement Eclairé, France
Association Liberté Information Santé, France
Jean-Pierre Eudier, Ligue Nationale pour la Liberté de Vaccination, France
Cathy Gaches, Reseau des Victimes de la Vaccination
Michel de Lorgeril et Philippe Harvaux, Association Internationale pour une
Médecine Scientifique Indépendante et Bienveillante, France
Carine Curtet, Association Ametist, France
Dr. Dominique Eraud, Coordination Nationale Médicale Santé Environnement
Bernard Clavière Croisade pour la santé, France*
Alexandra Oakley, Optim’autisme, France*

GERMANY

Libertas & Sanitas, Germany
Impfkritik, Germany
Artzen fur Individuelle Impfentscheidung, Germany
Impf-Info, Germany
Eltern fur Impfaufklarung, Germany
Hans U. P. Tolzin, NEFUNI, impf-report, Germany*

AUSTRIA

Aegis Osterreich, Austria
Impffrei, Austria

ITALY

Ader, Italy
Claudio Simion for Comilva, Italy
Ferdinando Donolato for Corvelva, Veneto, Italy
Colibri, Puglia, Italy
Comitatio Faenza, Italy
Genitori di Cervia per la Libera Scelta, Italy
Genitori del No Obbligo, Lombardia, Italy
Genitori del No Obbligo, Piemonte, Italy
Genitori per la Libera Scelta, Monza e Brianza, Italy
CliVa, Toscana, Italy
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Gruppi Uniti, Italy
Il Sentiero di Nicola, Italy
Libero per Tutti, Forli, Italy
Dario Miedico e Emiliano Gioia, SiAmo, Italy
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LUXEMBURG

Colette Welter, Aegis, Luxembourg

THE NETHERLANDS

Nederlandse Vereniging Kritisch Prikken, The Netherlands
Stichting Vaccinvrij, The Netherlands

BELGIUM

Dr. Kris Gaublomme, Preventie Vaccinatieschade, Belgium
Inititative Citoyenne, Belgique
Daniel Saelens, Ecole Royale Belge d’homeopathie, Belgium*

SPAIN

Asociacion de Afectadas por la Vacuna del Papiloma, Spain
Liga por la Libertád de Vaccunación, Spain

HUNGARY

Nebancs Viragegyesulet, Hungary
Kotelezo Helyett Valaszthato, Hungary

BULGARIA

Andrei Edrev for Alternative Energy, Bulgaria

LITHUANIA

Nepriklausomas Skiepu Informacijo Centras, Lithuania

POLAND

Justyna Socha, Piotr Jawornik Ogólnopolskie Stowarzyszenie Wiedzy o
Szczepieniach STOP NOP, Poland
Dragana Timotic, Inicijativa Nova, Citizen’s Initiative for Optional Vaccination,

SERBIA

Civil Initiative for Non Mandatory Vaccination

SLOVENIA

Civilna iniciativa za prostovoljno cepljenje, Slovenia
Simona Rupar and Boris Potocar, Natural Child Development
Association, Slovenia*

SLOVAKIA

Sloboda v Ockovani, Slovakia

CROATIA

Cijepljenje Pravo Izbora, Croatia
Dr. Ivana Delas for the Croatian Association of Parent Activists, Croatia

CZECH REPUBLIC

Rozalio, Czech Republic
Liga Lidskych Prav, Czech Republic

NORWAY

Foreningen for Fritt Vaksinevalg, Norway

DENMARK

Vaccinations Forum, Denmark

FINLAND

Suomen Homeopatian Akatemia, Finland

SWEDEN

Sara Boo, NHF, Sweden

SWITZERLAND

Netzwerk Impfentscheid, Switzerland
Infovaccins.ch, Switzerland

UK

John Stone, Age of Autism, UK
Anna Watson, Arnica, UK
Freda Birrell, Association of HPV Vaccine Injured Daughters, UK
The Informed Parent, UK
Jabs, Justice, Awareness and Basic Support, UK
Joan Shenton, Immunity Resource Foundation, UK

IRELAND

Irish Vaccination Awareness Group

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