Chapter 5: Article 3
You've learned from the FDA regulations that vaccines are not required to be tested against a placebo. Once vaccines are licensed you see that they are then given to the entire population, even though they usually are not tested on select sick populations. You've learned from the CDC that once an entire population is vaccinated, they never look back to see if the health of the population is improving, remaining the same, or deteriorating.
They call this science. I call it nonsense. Unfortunately, that's not the end, this story gets worse.
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 Ch4: Part 2, 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:
Because the committee did not find convincing evidence that the vaccine does cause the adverse event, the vaccine is safe.
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 to support or refute safety, 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. These inserts describe the various clinical trials that were conducted to gain licensing approval. 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 any prompting. As a clinical trial participant, the onus then falls on the parent to:
pay close attention to their child, for any and all other health, personality and behavioural changes,
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
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 an experimental 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 ahead I provide you a summary of those details, listing the length of time participants were followed. 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 attentive and careful monitoring period of the 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.
And again, the deficiencies in vaccine testing do not end there, continue reading to learn more.
CONTINUE to the next article Ch5: Article 4
Article Sources Here
Phase I, II, and III vaccine trials are small - medical paper titled FDA Regulation and Evaluation of Vaccines Here
CDC states that vaccines are tested on 1000s Here (some were but many weren't)
Statement by Dr. Lucija Tomlijenovic that vaccine trials don't look for serious adverse events Here
IOM Report - Adverse Effects of Vaccines Evidence and Causality Here
Canadian Vaccine Package Inserts Here
American Vaccine Package Inserts Here
US Government Table of Vaccine Injuries - explaining the different vaccine injuries that the Government provides immediate financial compensation for Here
Tedx Talks with Christine Stabell Ben - Overall Health of the Vaccinated Here
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