How are Vaccine Safety Studies Designed?

Updated: Apr 9

Chapter 5: Article 1


Through media, we're often told that vaccines go through a testing process that is incredibly stringent and rigorous. But reading the FDA testing regulations, we learn the opposite is true. (Ch4: Article 5)

We've been repeatedly told that vaccines are the safest medications. But did you know the USA Supreme Court concluded in 2011 that vaccines are unavoidably unsafe.

Let's look at that ruling, BRUESEWITZ vs. WYETH. It states (emphasis mine):

Unavoidably unsafe products. There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safety, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk...

So vaccines are unavoidably unsafe. They are biological products and they are deemed to be a protective public health measure.

With those unique types of classifications, which differ significantly from the classifications given to standard pharmaceutical drugs, vaccines DO NOT have to go through the rigorous, long term, randomized, double blinded, placebo controlled safety tests that most pharmaceutical drugs go through before receiving licensing approval. 

The CDC acknowledges that long term studies, looking at long term health outcomes in the vaccinated population, which would more accurately determine safety, have never been conducted. On their website they state:

Observing vaccinated children for many years to look for long-term health conditions would not be practical, and withholding an effective vaccine from children while long-term studies are being done wouldn’t be ethical...We also know there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects.


Though they’ve never tested long term affects, they believe that there wouldn’t be any serious long-term effects. Their statements are based upon theories and predictions, not scientific testing, measurement, and evidence. The believe the only long term affect a vaccine produces is anti-body production, everything else that happens must be minimal, minor and short lasting, and there is no value in studying for longer periods of time to learn .


The focus of testing is to determine whether or not the vaccine generates an antibody response and whether or not an immediate safety signal, like seizures or death, is observed. If the vaccine generates the antibody response, and few or none of the recipients sieze or drop dead, the health authority approves the vaccine for use and distribution. They don’t want to withhold an effective vaccine, they say withholding the vaccine to complete long term safety testing would be unethical. Consequently, randemized and well-controlled long term studies that could carefully evaluate safety, such studies are never done.

In Ch2: Article 2, I pointed to David Graham, the FDA whistleblower. In his interview and Congressional testimony (about heart attacks caused by the drug Vioxx), Graham explained that FDA regulation is set-up backwards - he explained that the FDA starts from a position of assuming the drug is safe. From there, the drug maker has to prove that the drug isn't safe. Obviously it's not in the company's best interest to find problems with the drug, so the company devises their testing in such a way to minimize any potential that a problem(s) will be discovered. He explained that if the drug maker DOES find a problem, the FDA insists the manufacturer show with 95% certainty that the drug is NOT safe. 

Graham explains that establishing this level of certainty in the pre-licensing testing is simply impossible. As a result, any health problems observed during clinical trials are dismissed as "coincidental." Because "95% certainty" cannot be established in the safety testing completed, that means that the FDA's assumption of safety is declared proven. The current opioid crisis is a perfect example of how unsafe drugs end up on the market. Keep in mind all 1st world nations models this backwards FDA regulatory setup. 

To provide you more quote examples, which emphasize how minimal safety testing is, I’ll direct your focus back to the IOM. Remember, the IOM has repeatedly been commissioned by HHS to complete reviews on vaccine safety. In the 1994 review, titled Adverse Events Associated with Childhood Vaccines Evidence Bearing on Causality, on page 317 it says (emphasis mine):

In the course of its review, the committee encoutered many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines. These include inadequate understanding of the biologic mechanisms underlying adverse events following natural infection or immuniztion series, inadequate size or length of follow-up of many population-based epidemiolgic studies, and limited capacity of existing surveillance systems of vaccine injury to provide persuasive evidence of causation. The committee found few experimental studies published in relation to the number of epidemiologic studies published. Clearly, if research capacity and accomplishment in these areas are not improved, future reviews of vaccine safety will be similarly handicapped.


This review was completed in 1994, and unfortunately “research capacity and accomplishment” have not improved since then. Back then, 54 adverse event/vaccine pairs were identified for evaluation, of them, 38 (70%) of those pairs suffered from inadequate study/data to draw any conclusion as to whether or not the vaccine caused the adverse event. In 2012 another review was completed, and 158 adverse event/vaccine pairs were identified, of them, 135 (85%) of those pairs suffered from inadequate study/data to draw any conclusion.


In 1994 the IOM explained that we are faced with limited understanding of the biologic mechanisms that lead to adverse events following vaccination or infection with illness. To the IOM, this lack of knowledge does not provide justifcation to conclude “there is not a plausible biologic reason to believe vaccines would cause any serious long-term effects.” as stated by the CDC.


That statement made by the CDC, we have no reason to believe a biologic mechanism is plausible, is shocking and almost laughable (if it weren’t so prideful and arrogant). I had an adorable and loveable dog once, who was as goofy as he was massive (90lbs). When I scolded him for doing something he knew not to do, he would hide his big head behind the toilet, or under the piano bench. His massive body would jutt out into the room, but I couldn’t see his eyes with his head hidden. I always laughed at the sight of him, with his massive back end on full display. I think he actually believed that because he couldn’t see me, he had become invisible and I couldn’t see him either. Of course his belief vs reality were at complete odds with each other.


Just because humanity is completely ignorant and lacking in wisdom and understanding, unable to see and recognize what biological mechanism (how and why) produce poor health outcome, that does not mean the mechanism (maybe trigged by vaccination) doesn’t exist. Remember, the IOM has informed us, “absence of evidence is not evidence of absence.” It seems the CDC needs to reflect on such reality.


Remember from 1986 to today, the childhood vaccination schedule has nearly trippled. In the 1994 IOM review, there were 54 adverse event/vaccine pairs being questioned, with few answers established. In 2012 the adverse event/vaccine pairing grew substantially, to 158, again, a near tripling (which is an interesting correlation).


Today, 70 doses of vaccine are now being adminstered from birth to 18 years of age (this does not include covid vaccination). Many of the vaccines are delivered via combination shots, resulting in 37 needles given in total over 27 wellness/flu shot appointments throughout childhood.


In 2013, the IOM discussed the increased vaccination schedule, in their review titled The Childhood Immunization Schedule and Safety. On page 129 they explain (emphasis mine):

Most vaccine research focuses on the health outcomes associated with single immunizations or combinations of vaccines administered at a single visit. Even though each new vaccine is evaluated in the context of the overall immunization schedule that existed at the time of review, individual elements of the schedule are not evaluated once it is adjusted to accommodate a new vaccine. Key elements of the immunization schedule—for example, the number, frequency, timing, order, and age at the time of administration of vaccines—have not been systematically examined in research studies.


The second major issue that the committee encountered during the review of the scientific literature was uncertainty over whether the scientific literature has addressed all health outcomes and safety concerns. The committee could not determine whether its list of health outcomes was complete or whether a more comprehensive system of surveillance might identify other outcomes of potential safety significance. In addition, the conditions of concern to some stakeholders, such as immunological, neurological, and developmental problems, are illnesses and conditions for which the etiology, in general, is not well understood. Further research on these conditions may clarify their etiologies.


So, what if a vaccine affects the immune system and body as a whole, on a broader scale? What if a vaccine's affect is not isolated to just antibody production? And what if that affect can change how your immune system responds to a multitude of things, not just specific bacterial or viral invaders. Immunologists admit that the immune system is a vast mystery, and that the majority of immune system actions have remained undiscovered and unknown.

An article prepared by Stanford Medicine quotes Garry Fathman, MD, a professor of immunology and rheumatology and associate director of the Institute for Immunology. Dr. Fathman says:

“If a patient were to ask me, ‘How’s my immune system doing today?’ I would have no idea how to answer that, and I’m an immunologist. None of us can answer that. Right now we’re still doing the same tests I did when I was a medical student in the late 1960s.”  

The article goes on to say (emphasis mine):

[The immune system is] staggeringly complex, comprising at least 15 different interacting cell types that spew dozens of different molecules into the blood to communicate with one another and to do battle. Within each of those cells sit tens of thousands of genes whose activity can be altered by age, exercise, infection, vaccination status, diet, stress, you name it.

“That’s an awful lot of moving parts. And we don’t really know what the vast majority of them do, or should be doing,” says [Mark] Davis [PhD, director of the Institute, and] the Bert and Marion Avery Family Professor in the Department of Microbiology and Immunology. “We can’t even be sure how to tell when the immune system’s not working right, let alone why not, because we don’t have good metrics of what a healthy human immune system looks like.”

In a sea of unknowns, anti-body levels are a measurable known. As a result, during vaccine testing, both past and present, a vaccine is injected into a person's body and then the person's antibody levels are measured to conclude whether or not the vaccine "worked." Unfortunately, researchers have not measured other immune system "markers"  to see if they too were affected. The Standford Medicine article explains that vaccination can alter the tens of thousands of genes within the immune system cells. So again I ask, what if a vaccine alters and affects much more than just anti-body production?

The poorly understood and vastly complex immune system determines an individual's ongoing health status, over the short and long term. The intent of vaccination is to permanently alter that immune system, creating antibodies where before there were none. So, in one breath, the CDC is saying it's absolutely necessary to intervene with vaccines to permanently alter the immune system, and then in the next breath they say it would be unethical to learn all the ways that vaccination did alter the immune system and did affect long term health. THAT makes zero sense. 

At any point in time over the past 70 years (since vaccines became widely used), each country's health authority could have insisted on monitoring and comparing the vaccinated and never vaccinated populations - remember there are many populations who have refused all vaccines despite the vaccines being offered and available to them. The authorities could have compared overall health, tracking rates of "unwell visits," visits to either an ER or doctor's office. They could have insisted on monitoring and comparing rates of infections and illnesses, rates and severity of allergies, rates of antibiotic and prescription drug need, rates of autoimmune, chronic and terminal illnesses, rates of addictions and quality of mental health, and rates of death (including suicides and accidents). All those events can be the end result of how well a person's immune system is functioning, or rather, not functioning. Remember the immune system does affect  the body as a whole. Medicine is now discovering that depression can be caused by immune system problems. Similarly, accidents can be caused by unexpected health or immune system triggered events. If you never had experienced a seizure before, but you had one for the first time while driving down the highway, and you died in the accident, was your "accidental death" the result of your car accident or your seizure? Who would make that connection? 

The health authorities should be monitoring the occurrence of those various conditions and events, comparing that data between a fully vaccinated population, a partially vaccinated population, and a never vaccinated population (who have chosen to refuse all vaccines despite those same vaccines being offered and available to them). Such a study could be done retrospectively, looking at existing health records. If such a study showed that the general overall health and long term health of the vaccinated population was significantly better, (i.e.: a lesser rate of chronic or terminal health conditions, fewer deaths earlier in life or longer life expectancy, etc) compared to that of a never vaccinated population, then vaccine hesitant groups and vaccine refusers would likely change their tune completely - which is what everyone wants right? Recognizing that such a study could abolish vaccine refusal from this planet, WHY then do the Governments continue to refuse to conduct this research? This makes zero sense. 

So if they don't study long term health in the vaccinated groups, what do they study? The next few articles will start breaking that down.

CONTINUE to the next article Ch5: Article 2

Article Sources Here

  • The FDA Website: What is a biological product? Here

  • Court Documents: BRUESEWITZ vs. WYETH LLC - Vaccines are unavoidably unsafe Here

  • The CDC: lack of long term health outcome studies in vaccinated populations Here

  • AMA Journal of Ethics - How FDA Failures Contributed to the Opioid Crisis Here

  • IOM 1994 review - Adverse Events Associated with Childhood Vaccines Evidence Bearing on Causality Here

  • IOM 2012 review - Adverse Effect of Vaccines Here

  • IOM 2013 review - The Childhood Immunization Schedule and Safety Here

  • Stanford Medicine - The immune system is poorly understood Here

  • Interview with David Graham, the FDA whistleblower Here

  • Transcript of David Graham's Testimony before US Senate Here

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