Vaccine Safety Testing - Placebo Controls

Updated: Nov 8

Chapter 4: Article 5


When I reflect on my childhood, on getting sick, I recall my mom speaking incredibly highly of vaccines. I remember her describing how smart the scientists were, that they learned you could give a weakened version of an illness through a vaccine, and that the vaccine would make your body stronger than before. She described that the scientists worked for so long, testing the vaccines in different ways on different groups of people with some receiving a placebo - placebo in her words was a fake medicine that looked real but it didn't do anything so no one knew if they received the test medication or not. She explained that those studies showed that people who received a vaccine instead of a placebo ended up healthier, and that's why vaccines are given today. 

Mom was my world. If she said something was so, I knew it was true.

And then a few short years ago I learned that vaccines are NOT tested against a placebo. I thought to myself, "If that was wrong, what else have I mistakenly believed to be fact."

High school science class taught me that when you establish a hypothesis, you must challenge that hypothesis in different ways to prove that your bias hasn't influenced your observations.

As a 16 year old high school student I understood the critical importance of a placebo control, yet today vaccine scientists think genuine saline placebos are unnecessary. This disconnect is baffling to me.

Let's take a moment to learn what the CDC and HHS have to say about the actions of placebos and the importance of placebos.The CDC defines placebo as:

“A substance or treatment that has no effect on human beings.”

HHS states (emphasis mine):

In undertaking a clinical trial, researchers don’t want to leave anything to chance. They want to be as certain as possible that the results of the testing show whether or not a treatment is safe and effective. The “gold standard” for testing interventions in people is the “randomized, placebo-controlled” clinical trial....A placebo is an inactive substance that looks like the drug or treatment being tested.

From the FDA, their Code of Federal Regulations 21 CFR 201.57, we learn how drugs and vaccines are tested. 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 ... 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."

And so, saline placebos are almost never used it vaccine trials.

But with that said, you will hear the media, the health authority, and your doctor make statements about the vaccine compared to placebo, or they will say a vaccinated group compared to an unvaccinated control group. Those statements need explanation. When you hear the term  “placebo” in a vaccine discussion, that "placebo" is one of three things:

  1. a different vaccine (for the same or a different illness)

  2. the vaccine solution without the antigen (antigen is the vaccine virus or vaccine bacteria)

  3. specific vaccine ingredient(s), like the aluminum adjuvant (the aluminum adjuvant in the vaccine boosts the immune response within the body)

And when the Health Authority says an “unvaccinated” person, that does not usually mean a person who has NEVER been vaccinated. Instead, “unvaccinated” also means one of three things:

  1. a person who has inadequate health records to prove which vaccines they've received or not received

  2. a person who is not fully up-to-date and vaccinated according to the most recent schedule (even if they are missing only one vaccine)

And in reference to a person participating in a clinical trial who is “unvaccinated” that participant is:

  3   a person who was given vaccine ingredients (less the antigen), or a control vaccine, either a

       competitor vaccine for the same illness, or a completely unrelated vaccine for a different

       illness.

In a later article Ch5: Article 6, I provide you a listing of all the vaccines used in Canada, showing a summary of the testing completed for each of those vaccines. That summary shows that none of the vaccines were compared to a genuine placebo, despite the term placebo being used often.

As a result of never using a genuine placebo control or a never vaccinated control group, the safety data that is available is very limited. The reality of current vaccine safety testing is that most clinical trials have never established a baseline, looking to see if the vaccinated populations experienced DIFFERENT reactions compared to a CONTROL group which wasn't vaccinated and received a genuine placebo.

To support why this is dangerous, I provide you with an article written by the American College of Pediatricians. In this article, they are discussing a potential adverse affect of Gardasil (an HPV vaccine). The safety issue discussed is just being recognized now, over ten years after Gardasil was originally approved for use in 2006. The condition in question is called premature ovarian failure (POF), and is also known as premature menopause. If Gardasil causes premature ovarian failure, the writer admits that the reaction was not identified in the pre-licensing safety trials, because the “placebo” used during the testing was a solution of vaccine ingredients.

The article states:

Few other vaccines besides Gardasil® that are administered in adolescence contain polysorbate 80. Pre-licensure safety trials for Gardasil® used placebo that contained polysorbate 80 as well as aluminum adjuvant. Therefore, if such ingredients could cause ovarian dysfunction, an increase in amenorrhea [loss of menstruation] probably would not have been detected in the placebo controlled trials.

It’s important to point out that Gardasil is now being recommended for girls as young as 9 years old. And it also needs to be noted that aluminum and polysorbate 80 are ingredients in many of the vaccines administered during infancy and childhood. If these ingredients cause premature ovarian failure, it would be nearly impossible to connect this resulting damage back to the vaccine, because the evidence of the damage would not reveal itself until years/decades after vaccination. Currently, vaccine clinical trials usually follow the health of the participants for a few days, weeks or months, and in some cases, for a couple years.

The varying degree and extent by which vaccination is affecting health is completely unknown. Until vaccine SAFETY trials use a genuine placebo, and until the health of trial participants is followed over the long term, we simply will remain ignorant to all the effects the practice of vaccination is having. 

CONTINUE to the next article: Ch4: Article 6

Article Sources

  • CDC Defines Placebo Here

  • HHS explains why using placebos are important Here

  • American College of Pediatricians Article Here

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