How are Vaccine Safety Studies Designed?

Updated: Jan 30

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.

The focus in vaccine testing is to determine whether or not it generates an antibody response. If the vaccine does, the health authority doesn't want to withhold its use - they say doing so would be unethical. Consequently long term studies that could carefully evaluate safety, such studies are not 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. 

Because the CDC (and all health authorities) believe it is unethical to study long term health outcomes in the vaccinated population, that means the health authorities are relying upon assumption - that vaccines cause only minimal, minor and short lasting side effects. 

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

  • Standford 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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