A reply to "Open letter ...to the WHO on the issue of vaccine safety"

A reply to "Open letter ...to the WHO on the issue of vaccine safety"

Infographic source: Leon Farrant
In a Dutch Facebook group titled "To Vaccinate: Yes or No?" (literal translation), someone posted this "Open letter to the WHO on the issue of vaccine safety", asking us what questions we think should have priority. A number of members were quick to comment that it's unclear what questions she means, calling it a bit of a word salad.

I'd like to take you through the open letter, posted by the European Forum for Vaccine Vigilance (EFVV) here. I'll try to provide both scientific papers and human-readable articles as sources and mark them as such.

My response to the letter

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, today 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

The first sentence sounds like it was written by genuinely grateful people. Yet the second sentence immediately implies that improved nutrition, clean water and improved hygiene (and access to medical care) are the primary causes of the reduce of mortality and infectious disease. Actually preventing the disease isn't in their list, which is illuminating. Similarly, they speak of the extraordinary campaign regarding Smallpox, without reference to the (central) role of vaccination in this effort. 

Then, they get to their point: Chronic disease. By now, we already have a fair guess of what they think is causing this, based on the first paragraph of the letter (and the name of the group publishing it).

The trailing number "2" refers to a CDC page, which also states most of these diseases are caused by a short list of risk behaviour: Tobacco use, secondhand smoke, poor nutrition, lack of physical activity and excessive alcohol usage. 

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.
Bad nutrition is, sort of per definition, bad for you. Yet this "toxic load" they speak of is not really a term I've seen used before, and it is not used on the CDC page. We also encounter their first real claim, which is that vaccines are not evaluated for long-term impact on the immune system and that vaccines are not evaluated for their potential role in chronic disease. Both of these claims are, not surprisingly, false. 

I'd like to (re)introduce you to a concept called Hitchen's RazorWhat can be asserted without evidence can be dismissed without evidence. The claims made in the Open Letter are stated as if they are true, but are they? They do not provide any evidence to support their claims. As such, the following is unnecessary, but I would like to show the evidence does not support their claims. The second claim is actually smaller than the first claim; chronic disease would indeed be a long-term effect and is studied (among other things) when studying the first claim. As such, we will treat this as a singular claim.

To evaluate their claim, whether or not vaccines are evaluated for long-term impact on the immune system. First, let me point out there is no reason to assume they would. Vaccines cause an immediate immune response to a weakened pathogen after which a person is immunised. Vaccinated children aren't sick more often on a short-term basis (paperarticle), nor on a long term basis ( paper, paper, article, article) . We can conclude that the claim is false; vaccines are evaluated for long-term impact on the immune system.

Recently, independent researchers and laboratories have discovered that many vaccines are contaminated with retroviruses 3 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
 It's extremely important to evaluate not only a claim, but also the sources that support it. This sometimes leads to a very lengthy exercise, but it's worth it.

Reference #3 refers to a book, Plague, whose author is former researcher Judy Anne Mikovits. The story, which they apparently wrote about in their book (which I'm not buying), is about how her paper in the journal Science was retracted. First, negative results were published soon, disputing her findings. A co-author stated that he was concerned about lab contamination. She was terminated by the Whittemore Peterson Institute, where she was a research director, after refusing to turn over her work to another scientist and came under investigation for data manipulation.

This book's title foreshadows a self-indulging story of heroism against the establishment, despite all the evidence to the contrary. Although such a piece sounds like intriguing fiction, it is not a very credible source.

The claim that vaccines are contaminated with retroviruses is rather high-impact. If this is actually found, it would break international news immediately. And even though such things are investigated, that hasn't happened.

Reference #4 supposedly supports the claim that vaccines are contaminated with nanoparticles. Nanoparticles sounds like something complex and kind of scary, something that the anti-vaccination crowd has been trying to put a spin on for a while. It just means "small particle", in this case something along the lines of small flakes of crystallised material. The reference itself mostly mentions that they measured the presence, proposes that these are a form of pollution and that removing them might increase the quality of vaccines.

In a very typical fashion, Reference #4 is published in what sounds like a pretty serious journal. Sadly, that's one of the tricks of predatory publishing,  and it indeed features on the most well-known list of predatory publishers (Beall's list). This article does a thorough job of discussing the fake paper, but the summary is that they made a pretty significant (and basic) error in sample preparation. The apparatus used puts the samples under vacuum, which means that a liquid sample immediately evaporates. As a result, precipitates remain - the nano-particles they saw. 

If anything, as that same article explains, the result of their investigation is that they found about 2000 nano-particles among roughly a billion billion billion particles (apparently, in an exa of particles). 

Reference #5 and #6 supports their claim that aluminium was found in the brains of autistic children or people suffering from neurological disorder. While interesting, we should start with the simple question of whether or not autism and vaccines are related. The answer is a rather resounding "No, it's not" (paper, article).

More specifically there are numerous errors in the methodology in the works of Exley, the author of References #5 and #6. Among the most evident errors in the methodology is a lack of controls. The clinical information is minimal and does not include dietary history, medical history or whatever. All of these swept under the rug in favour of the conclusion Exley wants to draw (article).

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 China 8, the tragedy of the oral polio campaign in India with over 450,000 cases of paralysis and death 9, the damage caused by the Dengue vaccine in the Philippines 10, 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.
Their Reference. #7 is about the WHO-NCL Network, not the full WHO, which they claim advocated for less independent testing. They're not talking about less independent testing, but about sharing information between manufacturers so they do not have to repeat tests already done elsewhere. 

Reference #8 is about the "China Vaccine scandal", which has nothing to do with the type of safety testing we were talking about. What apparently happened is that a particular manufacturer forged both production and inspection data, circumventing the inspection process and distributing a lot of faulty goods (drugs). While pretty bad, it is a complete side story that isn't really relevant when were talking about safety.

Reference #9 is hugely in favour of vaccins, but found a correlation between  non-Polio Accute Flacid Paralysis Rates (EFPR)  and Pulse Polio Frequency. To quote: "The polio eradication programme succeeded in drastically reducing the global spread of this disease, which was achieved through the use of immunization with OPV. While commending this enormous effort at eradication, our observation supports the hypothesis that the frequency of pulse polio administration is directly or indirectly related to the incidence of NPAFP." It is true that they find a correlation. But, as they mention themselves: "a simple association being found with regression analysis does not prove a causal relationship." However, this is not a closed issue; for instance, suggestions that the cause might lie with (other) enteroviruses are very credible as well (paper, article).

Reference #10 is the Wall Street Journal, a rather weird place for a reference about medical stuff. Their very short claim is that the damage caused by the Dengue vaccine in the Philippines shows that vaccine safety and efficacy are being tragically disregarded. There's no evidence of that, however. If anything, A rather odd effect seems to be happening, which wasn't clear in the initial screening: "WHO updated its recommendations regarding the use of Dengvaxia in September 2018 based on the evidence that seronegative vaccine recipients have an excess risk of severe dengue compared to unvaccinated seronegative individuals . It is not clear why the vaccinated sereonegative population have more serious adverse outcomes. A plausible hypothesis is the phenomenon of antibody-dependent enhancement".

References #11 and #12 are supposed to back up their claim of chronic pain and paralysis after administration of the HPV vaccine. However, the first is a complaint that was dismissed and the second is a book that repeats claims of the authors of retracted papers, essentially a way to try and circumvent peer-review (article).

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.
Reference #13 is again the WHO Network (duplicate of #7), which wants to share information amongst countries and manufacturers. Look back at the previous discussion of this point, but overall the complaints are just nonsensical. Amongst the participants are the national laboratories, which certainly will have an opinion regarding the safety implications for their individual countries.

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:
No, I do not agree that they fail in reassuring the public. Rather, a dangerous campaign of misinformation has been rampant by the signatures of this open letter.

Fast-tracking is not something officials have chosen instead, but rather something they set up to have rapid response to certain outbreaks.

• Extensive clinical trials conducted by bodies independent from the manufacturers
• Middle- 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• 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 done on vaccines
They want to make it sound like all of this isn't in place, but that's simply not true. For instance, regard "inert placebo testing": "Randomised, placebo-controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine. In these trials, participants are randomized to receive either the vaccine under investigation or a placebo (i.e. an inert substance, such as a saline injection)." (paper,  article) 

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.
All of these studies are in place: adjuvantsformaldehydesafetyglobal healthare unvaccinated children more healthyviral transmission.

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 numbers 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 7020 and 8190 deaths each year in infants in India14. It furthers appears that in confidential periodic safety reports of the hexavalent Infanrix polio vaccine submitted to the EMA, the manufacturer GSK has deleted a number of death cases between reports. 15
Both references #14 and #15 are by Puliyel, and involve the pentavalent vaccine and claim that Sudden Infant Death Syndrome (SIDS) cases increased after vaccination with the Pentavalent vaccine. The WHO response to this can be found here: "The findings of investigations and expert review of deaths following pentavalent vaccine in the 4 countries are reassuring although not all cases could be fully assessed due to incomplete case information." and "Pentavalent vaccines provide great public health benefits that accrue from the ability to protect against 5 major threats to health in a single injection. Currently, pentavalent vaccines from 5 different manufacturers re prequalified by WHO and considered to be safe, effective and of assured quality."

As far as I can determine, Puliyel is a anti-vaccine proponent. His published works do not seem to have the support of the medical community, even in his own country.

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. While an expert from the CDC has confessed in 2014 to having manipulated the data of a key reference study, no further investigations have been made yet.18 With one in 36 children diagnosed with an Autism 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.
What link with autism? That's not a proven thing, but a disproven thing. It's simply false (paperarticle). References #16 and #17 are cited to show that the WHO source is false, but are about a course case. It seems that they found a simple section on the website where they could do this, even though the WHO has far more  resources on the subject.

Reference #18 is their own "movie", a documentary called Vaxxed. Given the numerous, in-depth take-downs of this piece of unscientific propaganda I think we can consider the point moot.

Reference #19 isn't really important in that light. Considering the utter lack of a link between vaccination and autism, the prevalence of the latter doesn't matter.

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”; 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
The fragments quoted by the writers of the letter are from a motion that was raised within the Parliament. It was not a case of "the European Parliament calls for". When we look at the summary of that motion, we read: "Parliament noted that vaccination prevents an estimated 2.5 million deaths each year worldwide and reduces disease-specific treatment costs, including antimicrobial treatments. Accordingly, it noted with concern that epidemiological data on the current vaccination situation in Member States show important gaps in the acceptance of vaccines and that the vaccination coverage rates necessary to ensure adequate protection are insufficient. Members were concerned that growing and widespread vaccine hesitancy has assumed worrying proportions. In this connection, it pointed out that Europe is currently facing avoidable measles outbreaks in a number of countries owing to vaccine hesitancy.(summary) The motion is about transparency, with a goal of reducing vaccine hesitancy. The issue of bias is an issue of quality, not addressed in this motion. It is therefore rather weird to act as if it should be.

The "biased reporting" in Reference #23 is about something else entirely. One of its authors will come back soon. Reference #23 is a remark about a single such organisation (Cochrane, a NGO), and they responded to it. "In summary, we believe that the Cochrane Review represents a robust and accurate summary of the evidence." Part of their response is that some things were outside of the scope and that some parts are probably going to be part of the scope in the future of such reviews, due to a change in the community: "The article in BMJ Evidence-Based Medicine highlights issues that go beyond the HPV review and which have been the subject of many discussions. In recent years, evidence synthesis researchers in Cochrane and elsewhere have recognized that..."

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
Are pre-market authorisation studies exclusively carried out by manufacturers? And did the conflict of interest manifest in wrongdoing? Are there not procedures in place to prevent just that? "Much of the impetus behind the adoption of the legal framework stemmed from the determination to prevent a recurrence of the thalidomide disaster of the late 1950s, when thousands of babies were born with limb deformities as a result of their mothers taking a medicinal product during pregnancy." (Legal Framework)

That makes more sense. I'm going to point out that the European Medicines Agency (EMA) appoints people to scientifically evaluate the documentation provided by the manufacturers (EMA). These will also be able to check the consistency of the documentation to see any tampering, if any.  After marketing authorisation is granted, there is still a lot of oversight and after-market evaluation to make sure no harm is done.

Of course clinical trials cannot - and will not - capture all adverse events. This is one of the reasons why after-market evaluation is in place - so that it can take action when adverse events happen that were not captured in the trials.

Their next "fact" (note quotation marks) is that peer reviewed scientific journals have huge conflicts of interest and most studies are biased or false. That's a gigantic complaint, that would shock the world to its core if true. What are their sources?

Reference #24 is a letter by P. Goetzsche, whom claims a particular NGO - which stands for Non-Governmental Organisation -  is doing it wrong. Note that he was a member of that particular NGO which terminated him for his behaviour over the years, presented his personal views as that of the NGO even when acting as an expert witness for a criminal trial (which is outrageous)  (Cochrane statement). Reference #24 is Goetzsche's response to being expelled. It's rather silly - in his first line, he states that 6/13 members voted him out. Cochrane itself states it's 11 members. The board statement is extremely clear in its justification, which he claims wasn't given.

Either way, reference #23 and #24 are both utterly besides the point, as the open letter is to the governmental institutions. The internal conflicts of a non-governmental organisation are simply not relevant.

Reference #25 is a rather alarmingly titled "Why most published research findings are false" by a professor of (among things) medicine, health, policy and statistics (paper). However, it is not saying that the papers are biased, or that the studies are false. No, it is saying that the conclusions found are often later found inaccurate. That's exactly how it should be. Science is a process of incremental improvement. As the author states: "Is it unavoidable that most research findings are false, or can we improve the situation? A major problem is that it is impossible to know with 100% certainty what the truth is in any research question. In this regard, the pure “gold” standard is unattainable. However, there are several approaches to improve the post-study probability."

Finally, Reference #26 is a random book called "The Truth about the Drug Companies: How They Deceive Us and What to Do about It". Based on the summary of the book on Amazon, it wants the pharmaceutical companies to become public health institutions. I'm sorry, but that's not what companies are. I know, it's horrid - that is why we have governmental oversight. If you want public health institutions, I suggest you vote for parties that share that opinion.

The claim that "Only 1 to 10% of adverse events are being reported"  is hardly the fault of any agencies. I don't think those numbers are valid, but adverse events are reported by those experiencing it. If you don't tell a medical expert or report it yourself, how can you complain? I must also point out that only an extremely small number of reported, and thus alleged, adverse events are actually found to be caused by the relevant vaccine.

Reference #27 is the "Mandate for safer childhood vaccines". It states the secretary shall promote the development of childhood vaccines that result in fewer and less serious adverse events and improve the entire regulatory process and reporting (source). The pertinent line seems to be: "Within 2 years after December 22, 1987, and periodically thereafter, the Secretary shall prepare and transmit to the Committee on Energy and Commerce of the House of Representatives and the Committee on Labor and Human Resources of the Senate a report describing the actions taken pursuant to subsection (a) during the preceding 2-year period."

So, periodically a report of the preceding 2 years. That's not the same as a report every two years, which is what the letter claims.

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 Foundation, 28 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 recommendations 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.
The Open Letter's shocking information
is available on the WHO website.
Being funded by a private investor, a Foundation, isn't exactly a conflict of interest, especially when your financial sources are public

Independent studies and experts are involved, and always have been. And the assumption of liability was put aside by the Mandate the referenced themselves. The mandate was the result of vaccine hesitancy in the USA (source).

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.
Except that most mandatory vaccinations have been around for a longer amount of time, with independent research aplenty. Each separate country also has its own health system,  from the EU's EMA to more national level ones.
 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 honourable members of this assembly for their attention and pray they will open their hearts and minds to our message.
I suggest that we do something about echo chambers on social media, combined with fighting the self-inflated non-experts of the internet. Put more emphasis on schooling, so that people leave high school with a decent understanding of the world and everything.

Vaccines might not be safe, but the current data - both pre-market manufacturer data and actual medical scientists measurements - does show that global warming is real and vaccines work. 

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