Vaccine Safety and Efficacy Studies That are the Bases for Marketing Authorizations are a Complete Methodological Mess
“Vaccines are held to the highest standard of safety. The United States currently has the safest, most effective vaccine supply in history. Vaccines undergo a rigorous and extensive evaluation program to determine safety and effectiveness.” (U.S. Department of Health & Human Services. https://www.vaccines.gov/basics/safety/informed/. accessed on 28 January 2017)
Claims that vaccines “undergo rigorous and extensive testing”, that they are “held to the highest standard of safety”, etc., are lies. The sad truth is exactly the opposite. The studies that are the bases for marketing authorizations are a complete and utter methodological mess. They are designed so very badly that they do not allow the detection and evaluation of short-term, let alone long-term vaccination effects. Such methodologically so inadequate studies should never be part of the process of granting marketing authorizations. I have to emphasize here that the mass utilization of untested vaccines, i.e. vaccines that haven’t been reliably tested, isn’t rare. On the contrary, granting a marketing authorization to vaccines without methodologically sound studies of safety and efficacy is a rule, not an exception.
“The design of a study, the procedures used and the very execution of a project are the elements which determine to a great extent the quality of scientific work and the (in)validity of its results. Poor research design and methodology lead to lack of credibility of findings and, in case of medicinal products, to a potentially erroneous evaluation of efficiency, safety and profitability of the pharmaceutical preparation. The entire scientific research process, from planning to publication, is subject to a string of identified and well described mistakes, distortions and partiality. The latter can be an unintended consequence of poor mastering of the research process or lack of experience. Proneness to error, which is intrinsic to scientific work, also opens the door to deliberate and well thought exploitation of this possibility with the intention to manipulate” (Gajski 2009, p. 66).
If we summarize all that is wrong with the majority of safety and immunogenicity studies, including the ones submitted in the process of gaining a marketing approval, we get a truly chilling picture: instead of rigorous scientific studies in the true sense of the word, we have studies that are methodological mess. Studies that are, obviously intentionally, designed so poorly that they would be barely fit for a college assignment, if that. They are designed in such a way that they cannot reveal the actual safety and efficacy profile of individual vaccine, they do not allow for any reliable and correct evaluation of vaccines. Consequently, despite claims about “rigorous scientific studies”, millions of children are routinely injected with untested vaccines whose true safety and efficacy profiles remain largely unknown.
Below I briefly summarized the most common and typical methodological “flaws”.
1. Preclinical safety studies are often not done. And if they are done, they are so poorly designed and limited in their scope, that they are almost useless. However, preclinical (animal) studies are of immense importance; they are the only way to truly research vaccines’ side effects and should form an integral and unavoidable part of any registration process.
It is true that animal studies have their own set of problems (for example, it is often difficult to find an adequate animal model, results cannot be 100% applied to humans, etc.) but they do allow:
- invasive and frequent examinations and tests,
- longitudinal studies (over 3 generations or more).
Those are the three most important aspects. Researchers should sincerely and actively search for all kinds of side effects, including theoretical/hypothetical ones. Instead, they are actively shutting their eyes and looking the other way. Many injuries, abnormalities, pathologies, etc. can only be revealed by a proper autopsy, so this should form an integral part of every study. And in many instances, with each passing generation, effects (both good and bad) of certain substance become more pronounced, wider in scope and higher in intensity. To discover the true range of possible side effects, one has to look not only for long term effects as such (for example, effects that become apparent in few months or years), but also research how it would affect the third, fourth, fifth generation.
2. Pharmacokinetic studies are not required for vaccines. They aren’t required for any vaccine component, not even for adjuvants (EMA, 17 May 2005, p. 4; WHO, 17–21 November 2003, p. 14). Consequently, such studies – i.e. studies of the time course of drug absorption, distribution, metabolism, and excretion – aren’t done. In other words, vaccines are granted a marketing authorization without a single study about how their components act in the body, how are they absorbed, how and where are they transported, how they affect various organs, where are they deposited, how are they excreted, etc.
Of course, the lack of preclinical safety studies and pharmacokinetic studies is not the only problem. Tomljenovic and Shaw (2011a, 2630) stated that “to the best of our knowledge, no adequate studies have been conducted to assess the safety of simultaneous administration of different vaccines to young children. Another issue of concern is the lack of any toxicological evaluation about concomitant administration of aluminum with other known toxic compounds which are routine constituents of commercial vaccine preparations, e.g., formaldehyde, formalin, mercury, phenoxyethanol, phenol, sodium borate, polysorbate 80, glutaraldehyde. In spite of all this, aluminum adjuvants are generally regarded as safe and some researchers have even recommended that no further research efforts should be spent on this topic despite a lack of good-quality evidence […] to the best of our knowledge, no adequate clinical studies have been conducted to establish the safety of concomitant administration of two experimentally-established neurotoxins, aluminum and mercury, the latter in the form of ethyl mercury (thimerosal) in infants and children”.
3. Observation period is extremely short, often only 5–15 days after each vaccine dose and rarely more than 30 days. Such study cannot detect any medium- and long-term side effects. On the basis of a few weeks’ observation, vaccines are declared “safe” and pumped into millions of children worldwide.
4. Placebo (saline solution) is practically never used. Instead either an older version of a vaccine, a vaccine from different manufacturer or a vaccine’s solution without antigens (but with all the other substances, including aluminum) plays a role of “placebo.” Such studies are then shamelessly and manipulatively called “placebo-controlled.” All this despite the fact that adjuvants cause a large percentage of serious side effects (aluminum adjuvants, for example, cross the blood-brain barrier and more or less permanently lodge in brains, where they can cause inflammation, swelling, demyelination, etc.).
This strategy enables researchers (and producers, and institutions, and all the other players in this sordid story) to literally state that “the new vaccine is as safe as placebo” or that “the rate of side effects was comparable to those from placebo”. In this way they can relatively successfully camouflage the true (high) rate of side effects. This is again a nice example of “how to lie without actually telling a lie.”
This problem was also pointed out by Tomljenovic and Shaw (2011a, 2630–2632): “…for the purpose of evaluating safety and efficacy, vaccine clinical trials often use an aluminum-containing placebo, either containing the same or greater amount of aluminum as the test vaccine. Without exception, these trials report a comparable rate of adverse reactions between the placebo and the vaccine group (for example, 63.7% vs. 65.3% of systemic events and 1.7% vs. 1.8% of serious adverse events respectively). According to the U.S. Food and Drug Administration (FDA), a placebo is ‘an inactive pill, liquid, or powder that has no treatment value’. The well-established neurotoxic properties of aluminium therefore suggest that aluminum cannot constitute as a valid placebo. […] While direct application of aluminum adjuvants to the central nervous system (CNS) is unquestionably neurotoxic, little is known about aluminum transport into and out of the CNS, its toxicokinetics, and the impact on different neuronal subpopulations following subcutaneous or intramuscular injections. The reason for this is that under current regulatory policies, evaluation of pharmacokinetic properties is not required for vaccines. This issue is of special concern in context to worldwide mass immunization practices involving children whose nervous systems are undergoing rapid development. Furthermore, an immature developing blood brain barrier (BBB) is more permeable to toxic substances than that of an adult. In addition, there are critical periods in neurodevelopment that occur within first few years of postnatal life during which exposure to neurotoxic insults may induce central nervous system (CNS) damage. In that respect, it is worth noting that any potential CNS damage caused by aluminum in children may not be evident until a later stage of development”.
5. Since there is no true placebo, there is also no true control group. Vaccinated children are never compared to unvaccinated ones. Especially not to truly unvaccinated ones (i.e. to children that have never received any vaccine). Supposedly, it would be terribly unethical if a group of study children would receive a true placebo and remain unvaccinated for at least a few months. However, it is perfectly “ethical and rational” to inject millions of children with multiple doses of vaccines whose safety has never been tested. It is “ethical and rational” to vaccinate children with these untested vaccine, loaded with neurotoxins, while they are still developing, while their immune and nervous system are still very vulnerable.
6. Side effects are literally observed. There are no blood tests, no neurological examinations or any other adequate examinations. Only fever and swelling at the injection site are measured. Everything else is simply “observed”. By parents, who report their observations on diary cards. It is truly ironical that parental observations are accepted in the course of the study, yet are ridiculed, disregarded and negated in all other situations (like, for example, when concerned parents return to their doctor and report about child’s changed behavior, screaming, regression). Even when study children exhibit clear symptoms of potential neurological injuries (like high-pitched crying, irritability, somnolence, etc.), they are not properly examined. And as a rule, almost all reactions, especially the more serious ones, are “believed to be unrelated to the vaccine”.
7. Majority of clinical trials is financed by producers. And in the process of granting a marketing approval, all studies are financed and conducted by the producer. It would be very naive to think that this does not affects trial results. Independent research is scarce these days, but still, it “has repeatedly warned that drug companies may manipulate clinical trial designs and subsequent data analysis and reporting to make their drugs look better and safer […] Keeping in mind that ‘the primary interest of a pharmaceutical company is developing and selling pharmaceutical product’, one must ask whether rational vaccine policy decisions should be based on conclusions derived from an uncritical acceptance of flawed vaccine safety and efficacy estimates provided by the vaccine manufacturer” (Tomljenovic and Shaw 2012d, p. e13).
8. Study reports are often too incomplete. But, as pointed out by Gajski (2009, pp. 66–67), “the methodology and design of clinical trials can only be judged on the basis of trial reports. Even though there are rules of reporting, methodology is often described poorly and incompletely, with important data and, in particular, side effects’ reports missing. Manipulation with procedures and data in scientific research is a well-known phenomenon. Excluding a few persons from the sample or adding a singular event can already ensure statistical reliability and produce the desired results. In fact, even complete forgeries can find their way through the filter of the most prestigious journals, as shown by a study published in The Lancet journal in 2005. The study demonstrated beneficial effects of anti-inflammatory drugs on the incidence of the oral cavity cancer. However, later it was proven that the author simply made up the study, the patients and the course of their disease”.
In order to obtain at least an approximately reliable and realistic evaluation of a vaccine’s properties and actions, every study or summary thereof (including summaries of medicinal products’ characteristics) should contain at least the following information:
- time and place of the performance of the study;
- individual stages of the study with a detailed description of the design and course (including the timeline) of every stage;
- the number of persons included in each stage and their characteristics (age, health condition, etc.), the size and characteristics of each category of the persons involved;
- inclusion and exclusion criteria;
- reasons for withdrawal from the study and the number of persons who withdrew from every individual stage;
- detailed description of the executed procedures, e.g. in case of side effects, an accurate description of how long after each dose of vaccine the side effects were observed and recorded and how (whether they were only recorded and reported on cards by parents or whether any tests were performed – blood or neurological tests, magnetic resonance, etc.; if so, what were the results);
- the vaccination regime, what was used as placebo, the constituents of all applied substances, including the placebo;
- detailed description of the implemented protocols according to individual stages, including definitions of terms and criteria and explanations of deviations;
- a detailed numerical representation of all results, including all partial results according to individual stages and categories of participants.
9. Only healthy children are included in trials. While this is a rational choice (also from the methodological point of view) the problem is that in reality, practically all children are vaccinated or are supposed to be vaccinated, including the ones with existing neurological or immunological disorders, autoimmune diseases, etc. All these conditions can be caused by vaccination; if a child already suffers from one of them (either due to previous vaccinations or due to other causes) it is highly probable that vaccination would seriously aggravate his condition.
10. Vaccine is declared effective on the basis of its ability to induce the production of antibodies. However, the presence of antibodies does not equal protection, immunity, efficacy. Vaccine might even be completely ineffective, despite its ability to induce the production of antibodies. Thus, adequate animal studies in which both vaccinated and unvaccinated (control) animals would be exposed to infectious agents should be mandatory part of registration process. Instead, such studies are practically never conducted, much less submitted in the registration process.
You can find a detailed and in-depth analysis of studies that were submitted in the process of granting the marketing authorization for some of the vaccines (e.g. Infanrix, M-M-R II, M-M-RVaxPro, HBVaxPro, Procomvax, Recombivax-HB) in my book Ideological Constructs of Vaccination.
The book Ideological Constructs of Vaccination addresses, in evidence-based detail, the shakiness, dubiousness, often even falseness of the most common, self-evident and deeply rooted claims about vaccines – about their safety, efficacy, rigorous testing and regulation, etc. – thus depicting a disturbing image of states’ and scientific institutions’ operation. It is based on the author’s doctoral thesis with the same title.
In the first part, the author, Dr. Mateja Cernic, points out the socio-political aspects of vaccination, from the legal regulation of vaccination to discourses, ideologies and representations of vaccination critics by the media. This part is important, as it enables readers to learn about vaccination policies and practices and helps them understand why there are such fierce battles between the supporters and opponents of vaccination.
The second part, which focuses on ideological constructs of vaccination, represents the main body of the book, where the most common claims about vaccination are systematically analyzed. It presents, among other things, certain mechanisms through which vaccines influence an organism (e.g. damage the nervous system and the immune system). All claims are systematically supported by references to scientific articles, government documents and official statistics.
The decision whether to vaccinate their children or not is one of the most important decisions parents make in connection to their children’s health and life. Therefore, it should never be taken in haste, without consideration, but rather after a thorough examination of the issue. The book Ideological Constructs of Vaccination can help you with that decision. Read it BEFORE your next vaccination appointment.
What others said about the book:
Dr. Stephanie Seneff, a Senior Research Scientist at the MIT
“This book is proof that the anti-vax movement is science-based! This new book is a masterpiece that presents detailed scientific arguments for why vaccines are not the panacea that they are claimed to be. It is a much welcomed addition to the growing body of literature revealing the damage the vaccination program is doing to our children. It is particularly effective in its portrayal of the ideological constructs that are used without basis to defend vaccines and keep the general population uninformed of the reality in terms of risk/benefit tradeoffs. The arguments are well supported by an extensive bibliography. You should buy extra copies of this book ready to hand out to any of your friends who claim that there’s no science behind the anti-vaccine movement!”
Dr. Jayne LM Donegan, MBBS DRCOG DCH DFFP MRCGP MFHom
“It is a minutely researched, scholarly and very readable piece of work that will not disappoint the most thorough researcher or parent who is wanting to have the multiple topics and references to do with vaccination and health policy in one logically ordered resource. For anyone wanting to have a comprehensive, one volume, reference work to read about every aspect of vaccination science and policy, this is the one to get. I cannot recommend it too highly. Buy it and read it. You will be pleased that you did.”
 Since practically all vaccine studies (those used in the process of granting a marketing authorization and those published in scientific publications) have more or less the same methodological design and since we are talking about fundamental methodological flaws (especially when it comes to safety studies) this is the only rational explanation. And let me be perfectly clear about this: I do not think and I am not implying that researchers conducting these studies don’t have enough expert knowledge, that they don’t know how to conduct a proper study. On the contrary, they are masters of their trade, possessing vast knowledge about the subject. And it is precisely this knowledge that allows them to design studies portraying entirely false and misleading vaccine profiles without actually falsifying anything. People usually fail to understand or at least fail to appreciate that the same knowledge that allows one to conduct an impeccable, high-quality and rigorous study, also allows one to conduct a study that produces false results without any actual falsification involved. This holds true for all scientific disciplines, from sociology to medicine. And is one of the biggest and most overlooked problems of modern science.
 Generally, I am strongly against animal studies. Often they are nothing more than torture of helpless animals without any real value. But, unfortunately, in some instances, animal studies are necessary – researching pharmaceuticals, truly researching them, is often such a case.
 Three generations are minimum, and five generations should be sufficient. For more information about this, dive into the field of epigenetics.
 It is true that usable examinations, like for example magnetic resonance imaging (MRI), are far too invasive and damaging in their own right to be done on study population, especially frequently. There is no good solution to this problem (methodologically adequate animal studies are probably the best compromise). However, at least blood samples could be taken regularly (one of the things to look for are signs of inflammation) and some minimally invasive testing could/should be used at least on those children who exhibit symptoms of neurological injuries (unusual, high-pitched cry is one such symptom).
 In 1980, 32% of biomedical research in the United States was financed by the industry, and in 2000, it was 62%. Currently, most trials are industry sponsored, both in the EU and in the United States (Gøtzsche 2013, p. 57).
 Advisory Committee on Immunization Practices (ACIP) has published a list of “conditions incorrectly perceived as contraindications to vaccination (i.e., vaccines may be given under these conditions)”, which includes conditions such as stable neurologic conditions (e.g., cerebral palsy, well-controlled seizures, or developmental delay), autoimmune disease (e.g., systemic lupus erythematosus or rheumatoid arthritis), immunosuppression, etc. (ACIP, https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/contraindications.html#modalIdString_CDCTable_1; page last updated 12 July 2017).
 One of the (obvious) conditions that would have to be met is choosing the appropriate animal species, whose susceptibility to certain disease is similar to that of humans. Another condition that should be strictly met is using only those species that do not produce their own vitamin C. High enough doses of vitamin C can cure and clear almost every infection and significantly contribute to the chance of not developing it in the first place (for more about vitamin C, see Levy, 2011).
Dr. Mateja Cernic got her PhD in sociology in 2014 at the School of Advanced Social Studies – SASS (Slovenia, EU). Since 2011, she has worked at the same faculty as an Assistant Lecturer covering various subjects. Her main research interests lie in the areas of power, control, ideologies and discourses in everyday life and medicine. She first became interested in the topic of vaccination around 10 years ago – many years before the birth of her first child and without any previous personal negative experience.
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