In essence, society’s attention has become focused on vaccination, focused solely on this health treatment. But TREATMENT is not what creates health, treatment is what changes or manages a persons’ symptoms of poor health. Instead of focusing solely on the treatment, there needs to be a shift. We need to evaluate the treatment in the context of the whole - what is working about the treatment? What needs improving? What is failing completely? How does the treatment affect evolution of the species? And how can health be supported moving forward so that the treatment is no longer needed?
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May 18, 2018

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Vaccine Approval Is Fast Tracked - Part 1

This lengthy four part series about vaccine safety connects each individual issue presented in previous articles into the broader whole, and introduces issues not yet discussed. This series shows how all the individual issues contribute in creating a much bigger and more complex problem.


Part 1: provides general information on how safety studies are conducted for vaccines, and how that testing differs from the testing done for pharmaceutical drugs. 
 
Part 2: provides a detailed description of both HPV infection and the issues uncovered in the HPV vaccine testing. 

 

Part 3: provides a summary of the vaccine safety trials, described by the vaccine manufacturers themselves, in the package inserts for each of the childhood vaccines (except HPV vaccines)

Part 4: provides a description of safety trials and problems discovered after licensing, for the drug Vioxx and for the vaccines Pandemrix and Arepanrix. This series concludes with a discussion about post marketing surveillance and study. 

Part 1

Unlike pharmaceutical drugs, vaccines meet the statutory definitions for both a drug and a biological product. Also unique to vaccines, they are deemed to be a protective public health measure. The 2011 US Supreme Court ruling, in BRUESEWITZ vs. WYETH, explains that vaccines are classified as an unavoidably unsafe product. To quote from those court documents (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...

 

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 (what is referred to as the gold standard of research) that most pharmaceutical drugs go through before receiving licensing approval. (Specifics of this are explained in Part 3 of this series). We always hear that vaccines are rigorously tested to ensure they are absolute safe, this articles breaks down how that simply is not the case.

 

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.

 

The focus in vaccine testing is to determine whether or not it is effective, meaning whether or not the vaccine 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 Safety & Efficacy - Part 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, so they devise their testing to minimize any potential that a problem(s) will be discovered. He explained that if the drug maker DOES find a problem, the FDA's insists the manufacturer has to 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." Without establishing "95% certainty" that the drug is harmful, that means then that the FDA's assumption of safety is declared proven. The current opioid crisis is a perfect example of this reality. Keep in mind that the health authority of every 1st world nation models this backwards FDA's regulatory setup. 

 

When the CDC asserts that vaccines are perfectly safe, this claim is based upon the FDA's backwards regulation setup, and it's also based on their own refusal to conduct long term studies looking at the overall health of different populations of people.

 

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

 

But 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 the immune system is a vast mystery, that the majority of the immune system actions remain 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 looked at and 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, by 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, comparing 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 actions. Similarly, if you never had experienced a seizure before, but you had one for the first time while driving down the highway, was your "accidental death" the result of your car accident or seizure? 

 

The governments 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 conducted without withholding a vaccine from anyone who wants to receive it. 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. 

 

The Research They Do Conduct

Considering that the CDC admits that long term health outcomes have never been studied, it becomes important to ask, "What types of health outcomes are the focus of vaccine safety clinical trials?"

 

Before answering that question in detail, we need to first revisit some key pieces of information presented in the earlier articles, and we need to dissect a few unique nuances that are specific to vaccines. To do so, let's again revisit what David Graham had to say. In his 2005 interview, he stated the following (emphasis mine):

The FDA assumes the drug is safe and now it's up to the company to prove that the drug isn't safe. Well, that's a no-brainer. What company on earth is going to try to prove that the drug isn't safe? There's no incentive for the companies to do things right. The clinical trials that are done are too small, and as a result it's very unusual to find a serious safety problem in these clinical trials. Safety flaws are discovered after the drug gets on the market.

 

Vaccine Clinical Trials are too Small

Pre-licensing vaccine clinical trials, which involve at least three different phases of testing, aren't larger than pharmaceutical drug trials, which Graham describes as being too small. To quote from a medical research paper titled "Food and Drug Administration Regulation and Evaluation of Vaccines" (Here), it says:

There are typically 3 successive phases in the clinical evaluation of vaccine products under the [investigational new drug] regulations...Phase I studies are designed to evaluate vaccine safety and tolerability and to generate preliminary immunogenicity [anti-body production] data. Typically, phase I studies enroll between 20 and 80 subjects who are closely monitored throughout the duration of the trial. Phase II studies, which typically enroll several hundred subjects, evaluate the immunogenicity of the vaccine and provide preliminary estimates on rates of common adverse events. Phase II studies are often designed to generate data to inform the design of phase III studies. Sponsors are encouraged to meet with the [Center for Biologics Evaluation and Research] CBER for an end-of-phase-II meeting to discuss their proposed phase III study. The phase III trial provides the critical documentation of the vaccine's safety and effectiveness needed to evaluate the risk/benefit relationship of the drug and to support licensure. Phase III trials are large and typically enroll from several hundred to several thousand subjects. 

 

Words are relative, and such is the case with that quote. It's true, Phase III trials are in fact larger than Phase I or II studies, but Graham's quote emphasizes the reality that these Phase III trials are simply not large enough to discover problems. In a previous article I wrote, (Safety & Efficacy Part 1), I discussed the information presented by Dr. Marcia Angell, a former Editor-In-Chief of one of the world's most prestigious medical journals, The New England Journal of Medicine. She is also a senior lecturer at Harvard Medical school. Angell corroborates Grahams statement, that drug trials are too small to detect serious adverse events. In a lecture she gave, she stressed the fact that a drug's true safety profile cannot be adequately understood until the drug has been tested on 100,000s of people. She said that that kind of monitoring cannot happen until after the drug is licensed and is being used widely by the public. In Part 3 of this article series, I break down how many infants, children and adolescents each childhood vaccine was tested on in pre-licensing studies, so you can see for yourself. The majority of vaccines were tested on a few hundred, to a few thousand healthy people.

 

Vaccines are the Only Medication Given to an Entire Population

No other medication is given to an entire population, the healthy and the sick, at a uniform dose, indiscriminately across the entire population. All other medications are given only to select sick or injured populations, to treat temporary or chronic conditions, and those medications are adjusted according to the individual's unique health status, age, body weight, other medication exposures, etc. But with vaccines, it's a one size fits all approach. When it comes to other "one size fits all" products, we know that "the fit" will be likely be poor. Yet, with vaccines, this reality is denied. Infants born at different gestational ages, infants and children of different ages, body weights, nutritional status, health status, genetic pre-dispositions, medication exposures, toxin exposures, etc, all of those children receive the exact same medication as if they were the exact same individual. Some of the vaccines and doses given to infants and children are the exact same as those given to adults. 

 

Despite the fact that the Government now requires an entire population, healthy and sick, to be medicated with numerous vaccines, it's incredible that this same Government then refuses to scientifically test and measure whether the entire population's health, as a whole, is improving, remaining unchanged, or deteriorating. 

 

The Placebo Control Was Eliminated

An important difference between vaccine safety trials and pharmaceutical drug trials is that vaccine trials are very very rarely saline placebo controlled. The elimination of the placebo control significantly contributed to our current situation today. If placebo controlled testing had been required in all vaccine testing, that testing could have identified different health outcomes between the vaccinated and not vaccinated groups. 

 

Remember, the Standford article states that within each immune system cell sits "tens of thousands of genes whose activity can be altered by vaccination status." The bulk of vaccines are administered to the entire population during infancy and early childhood, which is the critical time period when the immune system is in fact programming itself into what it will become. Because long term studies have never been done, the long term affect that those vaccine-induced gene alterations had, on influencing the individual's immune system programming and performance, and influencing the healthy population's herd health, those affects are completely unknown. Also, the vaccine-induced changes imposed on an individuals' genetic code, the affect those changes have on the genetics of future generations, those changes are also completely unknown.

 

And even if placebo controlled testing were re-instated today, unfortunately it would still be impossible to determine what that original healthy baseline, in a "vaccine-free" state, might have looked like, recognizing that almost every first-world resident has since been vaccinated to some degree. If early immune system programming is altered by vaccine-induced gene changes, even with receipt of only a single vaccine, and if those vaccine-induced gene alterations negatively affect the immune system performance in some way, in either the individual or the individual's future offspring, or both, then today, even if we re-instate placebo controlled testing, at best, we will be comparing receipt of vaccine vs placebo, in bodies that were previously affected by vaccination.

 

Measuring safety, by only testing different amounts of the medication, yields limited data. For data comparisons to mean anything, there needs to be a baseline, and that baseline needed to first establish the difference between medication and no medication. Unfortunately, this wasn't done, it can't ever be corrected, and that deficiency will likely have an affect on all future testing and data.   

 

Recognizing that I state here that vaccines are never compared to a placebo, or to a group which has not received a vaccine, I need to explain that statement further, because you will often hear the media talk about studies that compared vaccinated populations to unvaccinated populations. When the Health Authority says “unvaccinated," rarely does that mean a person who has NEVER been vaccinated. Instead, “unvaccinated” almost always means one of three things:

  1. a person who has inadequate health records to prove their vaccination status

  2. a person who is not fully up-to-date and vaccinated according to the standard schedule of the time (even if they are missing only one vaccine). Nearly 100% of adults today, age 20 years and older, would be considered unvaccinated by this standard.

    And in reference to an “unvaccinated” person who is participating in a vaccine clinical trial:​

  3.  a person who receives a different vaccine. This  "placebo" could be a competitor's vaccine (that protects against the same illness), or it could be a vaccine that protects against a completely different illness.

The term "unvaccinated" is used often by media, by doctors and the health authorities, implying a never vaccinated person. However, the vast majority of those "unvaccinated" people received several vaccines in their past.

 

Vaccines are not Tested in Isolation

Another aspect that is unique to vaccine safety testing, is that unlike pharmaceutical drug testing, vaccines are rarely tested in isolation. The childhood vaccination schedule requires infants to receive multiple vaccinations against five to nine illnesses at each vaccination appointment. These appointments usually occur at ages two, four, six, 12 and 18 months of age. When testing a new vaccine in those age brackets, the researchers won't forgo the regularly scheduled vaccines so that they can determine the specific side effects caused by that new vaccine. Rather, the test vaccine and the scheduled vaccines are given all together in the same visit, sometimes they are even given into the same limb. When researchers observe side effects, they then conclude that it's impossible to determine which vaccine caused those effects. The Menjugate package insert alludes to this, saying:

"In infants and children aged 12 through 23 months, symptoms including crying, irritability, drowsiness, impaired sleeping, anorexia, diarrhea and vomiting were common after vaccination but there was no evidence that these were related to Menjugate rather than concomitant vaccines, particularly DTP."​ 

 

Researchers Don't Look for Serious Side Effects

Dr. Lucija Tomlijenovic has her PhD and is a vaccine researcher. Her primary area of focus is the impact of vaccines on neuronal development. In an interview she stated the following (emphasis mine):

...if one looks at the manufacturer's studies, they are often not designed to detect serious adverse events...There was a study done by a group of researchers, sponsored by GlaxoSmithKline, and they were looking at Cervarix [HPV vaccine]...and the authors acknowledged that none of the studies evaluated had been designed to detect auto-immune diseases. So obviously, you're not going to find what you're not looking for. And in spite of this obvious flaw, they conclude that there is no evidence that Cervarix is associated with increased risk for autoimmune diseases. And this is absurd, because you haven't looked for it. The study has not been designed to detect auto-immune diseases.

 

A Lack of Data is Represented and Emphasized as Proof of Safety

Remember in Safety & Efficacy - Part 11, I explained that whenever you hear statements like "there is no evidence of harm" it would actually be more accurate for them to state, "there is no evidence of safety or harm." But they never include the word "safety" in those types of statements. 

 

The Institute of Medicine (IOM), a highly respected American agency that provides advice to US government, addressed the lack of safety research and safety data for vaccines, in a report they prepared for the Government, titled: Adverse Effects of Vaccines, Evidence and Causality, they state:

...“the absence of evidence is not evidence of absence.”
 

Later, when discussing "absence of evidence," the IOM provides the following information (underline emphasis mine):

...The vast majority of causality conclusions in the report are that the evidence was inadequate to accept or reject a causal relationship [between a vaccine and subsequent medical condition]. Some might interpret that to mean either of the following statements:

 

  1. Because the committee did not find convincing evidence that the vaccine does cause the adverse event, the vaccine is safe.
     

  2. Because the committee did not find convincing evidence that the vaccine does not cause the adverse event, the vaccine is unsafe.

 

Neither of these interpretations is correct. “Inadequate to accept or reject” means just that—inadequate.

 

Even though the IOM very clearly states in this report that a lack of evidence (for harm or safety) does not prove anything, in vaccine messaging, you will regularly hear the statements, “no evidence of harm,” and “proven safe,” used interchangeably, as if those statements mean the same thing. They don't. Messaging like this is misrepresentation of the scientific data. Unfortunately, Government agencies, the media, and doctors all over the world, point at a lack of data, calling that "lack" convincing proof of safety. Nothing could be further from the truth. 

 

Researchers Only Look for Minor Short-Term Effects

Dr. Tomlijenovic stated that in pre-licensing vaccine safety studies researchers do not look for serious adverse effects. The CDC validates this - remember, they stated that studies "to look for long-term health conditions would not be practical" that means the studies have never been conducted. Because of that, I stated it becomes necessary to ask "What types of health outcomes are the focus of vaccine safety clinical trials?" To learn this, you need to review the vaccine package inserts provided by the manufacturers, which describe the various clinical trials that were conducted. I've reviewed each childhood vaccine package insert, and based on the data presented in each, the manufacturers show that the trials were designed, mostly, to monitor vaccine recipients for minor, short term health effects. That's it. For example, how many participants experienced a runny nose, vs how many didn't, etc. 

 

Below, I've provided a consolidated list of the various minor, short term reactions that clinical trial participants are specifically watched for during vaccine clinical trials. The reactions are as follows:

  • Fever / Chills

  • Sweating

  • Flushing

  • Malaise (feeling unwell)

  • Sore Throat

  • Rhinorrhea (excess mucous secretion from nose)

  • Ear Ache or Ear Infection

  • Upper Respiratory Infection

  • Cough

  • Irritability

  • Prolonged and Unusual Crying and/or High pitched Screaming

  • Fatigue / Drowsiness

  • Impaired Sleeping / Insomnia

  • Loss of Appetite

  • Abdominal Pain / Cramps

  • Nausea / Vomiting

  • Diarrhea

  • Hypersensitivity

  • Apnea (suspension of breathing)

  • Hypotonic-Hyporesponsive Episode (Collapse or shock-like state, which can involve cardiovascular or respiratory arrest)

  • Allergic Reaction / Anaphylaxis

  • Angioedema (swelling of the lower layer of skin and tissue just under the skin or mucous membranes. The swelling may occur in the face, eyes, lips, tongue, larynx, abdomen, or arms and legs.)

  • Urticaria (Hives)

  • Rash

  • Dermatitis (eczema, itchy, red rash)

  • Lymphadenopathy (disease in lymph nodes producing swollen or enlarged lymph nodes)

  • Nodule formation (elevated areas of tissue or fluid inside or under the skin that feels hard and has a diameter greater than 0.5 cm)

  • Swelling (of limb, joint(s) or localized at injection site) 

  • Erythema (redness of the skin)

  • Ecchymosis (bleeding under the skin, causing bruising larger than 1cm)

  • Pruritus (undesirable feeling on skin, which provokes desire to scratch)

  • Paresthesia (sensation on the skin, tingling, prickling, burning, numbness)

  • Pain (at injection site, muscle pain, body ache, joint aches or headache)

  • Muscle Weakness or Stiffness

  • Hypotension (low blood pressure)

  • Vertigo, Dizziness, Lightheadedness, Fainting

  • Dysuria (painful urination)

  • Death

 

Parents are left to Decide What Other Side Effects to Report

In the package inserts, the reactions listed above are referred to as "solicited events." Most package inserts do not provide a definition for "solicited" or "unsolicited events." However, the Flumist insert did define the former as follows, "Solicited events were those about which parents/guardians were specifically queried after vaccination." Based on that definition, one can then infer that "unsolicited events" are those event(s), reaction(s) or condition(s), that the parents are not asked about. The parents report those events without prompting. As a clinical trial participant, the onus then falls on the parent to:

  1. pay close attention to their child, for any and all other health, personality and behavioural changes,

  2. identify that as a clinical trial participant, all events which appear abnormal compared to the person's status quo condition, need to be reported to the researchers, regardless of whether or not the parents believe the two events are linked, and

  3. report all events to the researchers.
     

I will provide an example to clarify what I'm getting at here. Let's say a parent 
observed "weird behaviour" from their child that didn't match the child's usual personality, emotions, actions, or physical coordination, etc, and that these behavioural differences started three weeks after the child participated in the clinical trial and received a test vaccine. It is not the parents' job to determine whether or not those two events (vaccination and behaviour changes) are related. Rather, the parent is obligated to report any and all differences, period. It's not unusual for the symptoms or behaviours of new onset illnesses to be completely misunderstood or brushed off initially, by parents and doctors alike, as "nothing," or "just a phase that the child will grow out of," at least for a period of time after the symptoms initially present. Without specifically queried questions from the researchers, in this instance about behaviour, personality, physical coordination, etc, it's quite likely that parents would fail to recognize that what they witnessed in their child's behaviour needed to be reported. This lack of follow-up and queried questioning by researchers results in a significant void in the data that has been collected, because lay people are not usually capable of promptly recognizing those symptoms which are indicative of chronic illness.

 

The Safety Monitoring Window is Extremely Brief

Again, recognizing that the CDC has informed us that long term studies have never been conducted to look at long term health outcomes, it becomes important to not only pay attention to what the trial participants are specifically monitored for, but also to identify exactly how long trial participants are followed closely. I've reviewed all of the package inserts for the recommended childhood vaccines, and in Part 3 I've summarized those details, listing the length of time participants were followed, for the above listed solicited events. Of 62 safety studies that are specifically described by the manufacturers, which involved infants, children and adolescents, nearly 80% of those studies closely monitored the participants (for solicited events) for 15 days, or less. 

 

This is in stark contrast to how safety is monitored during drug trials. According to the FDA, phase III drug trials typically run for one to four years. During this time health outcomes in both the placebo and study groups are followed continually. This is because these trial drugs are usually taken regularly and repeatedly on an ongoing basis to treat a medical condition, and as such, the safety monitoring period is ongoing throughout the trial period for several months or several years. That is not how testing works in vaccine trials.

 

To explain how vaccine trials work, let's use an example where a vaccine trial runs for four years, and three doses of vaccine are tested on the trial participants. Vaccine doses are usually administered in the first three to six months of a trial. The participants anti-body levels will be measured at various intervals over the entire four year period, to determine effectiveness which they refer to as the vaccine's "efficacy." But for the safety evaluation, the monitoring period of participants health is typically reduced to 14 days, or less, following receipt of each dose of vaccine. That means, in this example with three doses of vaccine, the participants health will be closely monitored for 14 days x 3, for a combined total of 42 days over the entire four year trial. For many vaccines, the safety monitoring window is even less than 14 days, and participants are only monitored closely for one to seven days after each dose of vaccine.

 

The Occurrence of Serious Adverse Events are Minimized and Dismissed

When serious adverse events, including death, are observed during the safety monitoring period, most package inserts minimize the occurrence of those events by: 

  1. describing the statistics of serious adverse events and deaths as comparable across all trial groups. But remember a genuine saline placebo was omitted from the trial and all trial groups received vaccines or vaccine ingredients

  2. suggesting the side effect or death was only "temporally related," that "a causal relationship has not been established." In previous articles I've explained that in order to determine if the vaccine plays a causal role, they would need to conduct an appropriate study with a control group that either received a placebo or was never vaccinated. Unfortunately, they refuse to conduct such a study.

  3. describing the serious adverse event or death as "considered unrelated to vaccination." These determinations are based upon the researchers personal opinion and bias, not on scientific measurement and comparison to a placebo / unvaccinated group. 


Also, in the vaccine package inserts, each time the manufacturers mention a serious adverse event or death, that is their way of covering off their legal liability. By providing this information, it gives them some legal protection. Should a person experience that medical condition or death following vaccination, and should that person or their family try and sue the manufacturer for damages (in many countries like the US you CANNOT sue the vaccine makers) the manufacturer then points to the package insert, to that specific data or warning, saying, "We provided that information, in warning, and by accepting receipt of this vaccine, they agreed to accept any such risk that they might in fact experience that outcome."

 

If you read the FDA's drug labeling laws, those laws explain that the manufacturer must NOT list every side effect that was witnessed during the testing, but rather, the label must list only those side effects that likely could be caused by the drug or vaccine. And therefore, if an adverse effect is mentioned in the vaccine package insert, it's because the manufacturer recognizes the relationship is potentially causal. This FDA legislation states:

"Adverse Reactions...This definition does not include all adverse events observed during use of a drug, only those adverse events for which there is some basis to believe there is a causal relationship between the drug and the occurrence of the adverse event."

 

Below I've provided several quotes from the manufacturers package inserts, from the "Warning and Precautions" secondary and the "Adverse Events" section, showing how the manufacturers warn the consumer to provide themselves legal protection. Look for how they try to minimize and dismiss the various concerning outcomes, by saying such outcomes were comparable to other vaccinated groups, that the event was only temporally related to vaccination, or was assessed by investigators as unrelated to vaccination. They can make these vague and inconclusive statements because they don't have to do proper testing against a placebo control. Regardless how they try to dismiss or minimize the relationship, if the adverse event is listed, it's because there is a basis to believe the vaccine could have caused it.

 

The statements are as follows (emphasis mine) (Links to all the package inserts can be found here):

Pediacel

Sudden infant death syndrome (SIDS) has occurred in infants following administration of DTaP vaccines. By chance alone, some cases of SIDS can be expected to follow receipt of PEDIACEL.

 

...Rates of serious adverse events were less than or comparable to the rates in the other acellular pertussis and European [vaccinated] groups in this study. 

 

Infanrix-Hexa

Extremely rare cases of Sudden Unexpected Death (SUD) in close temporal association to vaccination with INFANRIX hexa have been reported in the first year of life. However, a causal relationship has not been established.

 

Adacel-Polio

In these two studies, the safety profile of ADACEL- POLIO, both in frequency and severity of adverse reactions, was shown to be very similar to that of ADACEL when given in children 3.0 to 5.0 years of age as a pre-school booster. 

 

Imovax-Polio

Although no causal relationship has been established, deaths have occurred in temporal association after vaccination of infants with IPV.

 

Menactra

In infants and toddlers who received 2 doses of Menactra alone (at 9 months and 12 months) or the second dose of Menactra with concomitant routine pediatric vaccines, the percentage of subjects with at least one [serious adverse event] SAE after each vaccination was 2.0% to 2.5%. [If these serious adverse events are vaccine caused, this rate is significantly higher than the 1 in a million that we are always told about] In participants who received one or more pediatric vaccines without the co-administration of Menactra at 12 months of age, SAEs occurred at a rate of 1.6% to 3.6 % depending on the number and type of vaccines received.

 

Prevnar 13

During the 13 controlled clinical trials, death occurred in 4 (out of 7,489) infants. All 4 cases were attributable to Sudden Infant Death Syndrome (SIDS). Three (out of 4,729 cases receiving 15,739 doses) cases were among Prevnar 13 recipients, and 1 (out of 2,760 cases receiving 9,030 doses) was in the Prevnar (7-valent) group. None of these cases were assessed by the investigator as causally related to vaccination. 

 

Synflorix

In booster studies 8 (out of 19,466 subjects) receiving a booster dose of SYNFLORIX and one (out of the 1011) 7- valent PCV vaccinees reported an SAE with a fatal outcome. None of the fatalities reported in the booster studies was considered by the investigator to be causally related to vaccination.

 

Fluzone

There were no deaths considered to be caused from vaccination for any of the subjects.

 

MMR-II

Death from various, and in some cases unknown, causes has been reported rarely following vaccination with measles, mumps, and rubella vaccines; however, a causal relationship has not been established in healthy individuals.

 

...Only 8 subjects (3 recipients of M-M-R II with rHA and 5 recipients of M-M-R II with HSA) experienced a serious adverse experience during the safety follow-up period. None of these 8 serious adverse experiences was determined by the investigator to be vaccine-related. 

 

Cervarix

Among females 10 through 25 years of age enrolled in these clinical studies, 6.4% of subjects who received CERVARIX and 7.2% of subjects who received the control reported at least one serious adverse event during the entire follow-up period (up to 7.4 years).

 

...The pooled safety database, which included controlled and uncontrolled trials which enrolled females 10 through 25 years of age, was searched for new medical conditions indicative of potential new onset autoimmune diseases. Overall, the incidence of potential NOADs, as well as NOADs in the group receiving CERVARIX was 0.8% (95/12,533) and comparable to the pooled control group (0.8%, 87/10,730) during the 4.3 years of follow-up (mean 3.0 years). In the largest randomized, controlled trial (Study HPV-008) which enrolled females 15 through 25 years of age and which included active surveillance for potential NOADs, the incidence of potential NOADs and NOADs was 0.8% among subjects who received CERVARIX (78/9319) and 0.8% among subjects who received Hepatitis A Vaccine [720 EL.U. of antigen and 500 g Al(OH)3] control (77/9235). 

 

A Risk-Benefit Assessment for a Drug is Never Conducted

Back to David Graham's interview, in it he made a few statements related to a drug's benefit and risk. On that topic, he had the following to say (emphasis mine):

Another aspect to the culture at the FDA is that it overvalues the benefits of drugs and undervalues the risks of drugs. And so the FDA will always say to you, "Well, we're leaving this drug on the market because the benefits exceed the risks." Well, the FDA has never assessed the benefit of any drug that it's ever approved. It works on what's called efficacy. Does the drug work or not? Does it lower your blood pressure or does it lower your blood sugar? Not: Does it prolong your life? Does it prevent you from having a heart attack? Those are benefits. All they focus on is efficacy.


To frame that statement into the context of vaccines, what his statement means is that vaccines are effective at generating an anti-body response. Each vaccine has been scientifically tested and measured, to demonstrate that it does in fact produce an antibody response within the human body (to various degrees). When he says that "the FDA has never assessed the benefit of any drug that it's ever approved," that statement, in the context of vaccines, means that vaccines have NOT been scientifically tested and measured to determine whether or not having a vaccine induced anti-body level then makes a vaccine recipient immune to the illness. Vaccines have never been carefully tested to measure whether or not they improve the individual's health (in the short or long term) and a person's longevity. We regularly hear that vaccines create herd immunity and protect vulnerable infants and the immunocompromised. Again, there has never been any testing completed to evaluate the truth of such a claim. And although we regularly hear that vaccines save lives, the manufacturers and health authorities have never tested vaccines in anyway that could prove whether or not that is in fact the case. Each of those proclaimed outcomes are benefits, and as Dr. Graham, a senior scientist working in the Office of Drug Safety at the FDA has explained, the FDA has never measured the benefit of any drug they have ever approved. To scientifically test and prove each of those benefits, vaccine studies would have to compare extremely large populations of vaccinated and never vaccinated people, and follow them over the long term. The CDC has clearly stated that such scientific research has never been conducted.

 

A recent Ted Talk given by a physician and Global Health Professor Christine Stabell Ben, explains this very fact. We'll dive deeper into the content of this Ted Talk at a later date, but in her introduction she explains that the overall health of vaccinated populations has never been studied, until she and her team choose to study this themselves. She says:

Allow me to tell you what we discovered. In Guinea Bissau. We have a field station where we follow 200,000 people with regular home visits, and we register all deliveries, all vaccinations, all hospitalizations, health centre visits, all child deaths. And with this information, we started doing what no one else had done before, we evaluated the effect of vaccines on overall health. This may come as a surprise, but normally, vaccines are not assessed for their effects on overall health. They're only assessed for their protective effects against the vaccine disease. Everybody has been so convinced that vaccines only had protective effects against the vaccine so it didn't seem necessary to assess their effects on overall health. But when we started looking at the effect of vaccines on overall health, it quickly became clear that there was something wrong, something was clearly missing in this equation.

 

She goes on to explain:

Our findings can be summarized in one sentence. We discovered vaccines train the immune system in ways that no one expected.

 

There's much to say about her Tedx Talk and the research she presented, but I'll save that for another day.

 

To expand your understanding of a vaccine's purported safety, I've provided a summary of how each vaccine was tested, as described by the manufacturer. You'll find this summary in