Chapter 5: Article 2
The CDC admits that long term health outcomes in the vaccinated population have never been studied. Recognizing that, it becomes important to ask, "What types of health outcomes are the focus of vaccine safety clinical trials?"
The next three articles in this chapter will answer that important question.
To begin, we need to first remember a fundamental limitation within all drug and vaccine trials. Let's revisit what David Graham had to say in his 2005 interview, (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, (Ch2: Article 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 an article to come (Ch5: Article 6), 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
An important point to note about vaccines, is that they are 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. (More will be explained on this in a later article - Ch9: Article 2)
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 the early days through to today, that testing could have identified different health outcomes between the vaccinated and never vaccinated groups.
The FDA subtly acknowledges the elimination of placebo from vaccine trials, within their Code of Federal Regulations. The regulations state (emphasis mine):
Any statements comparing the safety or effectiveness of the drug with other agents for the same indication must, except for biological products [vaccines], be supported by substantial evidence derived from adequate and well-controlled studies as defined in 314.126(b) of this chapter unless this requirement is waived under 201.58 or 314.126(c) of this chapter. For biological products, such statements must be supported by substantial evidence.
The omission in that regulation is revealing. Though pharmaceutical drugs need "substantial evidence" demonstrated through "adequate and well-controlled studies," vaccines aren't held to that same standard. Vaccine studies need not meet the standard of "adequate and well controlled."
Coming up, in Ch5: Article 6, I summarize the vaccine package inserts, which are produced by the manufacturer, walking you through the clinical trials the manufacturer describes, showing what the experimental vaccine was compared against. Most package inserts clearly show the vaccine wasn't compared against a saline placebo control. At the end of that article you will find a link to all the Canadian and American vaccine package inserts, so that you can verify this for yourself.
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 most critical period of time 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 individual's genetic code, the affect those changes have on the genetics of future generations, that too is also completely unknown.
The term "mutagenic" means the production of genetic mutations, and again, you can read the vaccine package inserts to learn from the manufacturer if they tested the vaccine for any mutagenic potential. In the Canadian vaccine package inserts this information is more difficult to find, as the majority of Canadian package inserts are silent on this point. But if the Canadian insert does mention it, it's typically detailed in the section titled Toxicology and is easiest to find if you do a word search for "mutagenesis." To provide example, the Cervarix vaccine package insert says, "Carcinogenesis and Mutagenesis No studies were done on CERVARIX." Another example is seen in the Flulaval package insert, which says, "FLULAVAL TETRA has not been evaluated for carcinogenic or mutagenic potential."
But as I said, the majority of Canadian vaccine package inserts are silent on this. However you can see this more clearly by reviewing the American vaccine package inserts. Most provide a section 13.1 titled Carcinogenesis, Mutagenesis, Impairment of Fertility. In this section you'll see the inserts state, "[the vaccine] has not been evaluated for mutagenic potential."
Remember, mutagenic changes are all unknown because vaccines have never been tested against genuine saline placebos.
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 nearly all first-world residents has since been vaccinated to some degree. If early immune system programming is altered by vaccine-induced gene changes, even with receipt of 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 was never 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, 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:
a person who has inadequate health records to prove their vaccination status
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:
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" did people receive several vaccines in their past.
In part three of this series, I list the placebo or control used in the testing of each vaccine, as was described by the manufacturers.
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 to monitor carefully for any specific side effects caused by that new vaccine. Rather, the scheduled vaccines and the experimental test vaccine are given all together in the same visit, sometimes they are even given into the same limb. Later, 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."
Unfortunately, the deficiencies in vaccine testing do not end there, continue to the next article to learn more.
CONTINUE to the next article Ch5: Article 3
Article Sources Here
Phase I, II, and III vaccine trials are small - medical paper titled FDA Regulation and Evaluation of Vaccines Here
Interview with David Graham, the FDA whistleblower Here
Transcript of David Graham's Testimony before US Senate Here
FDA- Vaccine testing does not have to be adequate and well controlled Here
Stanford Medicine - The immune system is poorly understood and vaccination alters genetic activity of cell Here
Lecture by Dr. Marcia Angell - A drugs safety profile is discovered after licensing Here
Menjugate package insert Here