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Evaluating Vaccine Safety Trials

They call this 'science'

The medical community and the media hang their hats on the use of ‘double-blind, placebo-controlled, peer-reviewed studies published in legacy journals such as The New England Journal of Medicine (NEJM) and the Journal of the American Medical Association (JAMA). In a future substack, I will go into detail about the fallacies, and even the scam, of peer review and why it should not be held out as sacrosanct.

For today’s discussion, let’s take a look at why all vaccine research should be questioned. Yes, ALL of it. If you read enough studies, you’ll see the patterns described below. For this substack, I’ll use this study on the safety of hepatitis B vaccination in children in India as an example. The vaccine used, Revac-B, contained both 0.5mg of aluminum and 0.05 mg of thimerosal, considered to be safe.

1. Vaccine trials can be quite small and include only healthy children.

Every study begins with ‘selection criteria’ that describe including only healthy individuals. This is from the hepatitis B study example:

All 60 subjects included in the study were in good health and had a negative history of hematological, renal, hepatic, or allergic diseases. All were screened and found to have normal blood panels, including normal liver enzymes.

When a vaccine trial has been completed, the vaccine is recommended for ALL children, regardless of their health condition, family history, or genetics. In fact, the new shot is most ardently pushed on children with underlying health concerns, such as seizure disorders, cardiac anomalies, and conditions such as cystic fibrosis or Down’s syndrome. These children become the next round of experimentation because the vaccines were never tested for safety on these groups and others.

2. Vaccine studies follow for side effects for a short period of time.

Most clinical trials monitor for side effects for a paltry 21 days, often less. In some studies, such as in the example we are using, children were monitored for 5 days by study monitors and 5 days by cards given to parents. If no reactions occur, the shot is deemed to be ‘safe.’

However, it can take weeks to months for immune and neurological complications to appear. These arbitrary deadlines, allowed by the FDA, prohibit making the connection between vaccines with chronic health disorders. If an illness emerges later, of course, the doctors will say it has nothing to do with the vaccine.

3. Most vaccine safety studies do not use a true placebo.

The gold standard in medical research is the "placebo-controlled" trial. A placebo is an inactive or inert substance, such as a sugar pill or a shot of saline. In the trial, the placebo is given to one group, while the treatment group is given the experimental product. The placebo arm is used to ‘blind’ the study so the investigator doesn’t know if the subject received the Real Thing or the Inert Substance to minimize interpretation bias.

When reading a published vaccine trial, the substance used as the placebo is often not identified; it is simply called ‘placebo.’ For example, in this study for a new hepatitis B vaccine to treat chronic hepatitis B, the word ‘placebo’ is used 22 times but we don’t know what it is.

That’s a problem. The substance used as a ‘placebo’ is often not inert; it may be another vaccine. For example, I remember reading a study where the meningitis C vaccine was used as a placebo because it was considered to be non-immunogenic and non-reactive. Or, in the instance of the Gardasil (HPV) vaccine, the ‘placebo’ was an injection of aluminum.

All studies [for the Gardasil vaccine] were placebo-controlled and the total population that received a placebo included 9,701 subjects. The placebo was aluminum adjuvant in all studies except study 018 (pre-/adolescent safety study) which used a non-aluminum-containing placebo [and we don’t know what that placebo was].


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