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It is well established that the best and only true way to verify the safety of any medical trial is by performing a double-blind study against an inert placebo such as saline solution.  According to the National Institute of Health, it is the “gold standard” for intervention-based studies. The vast majority of vaccines administered today have not been through any form of rigorous safety testing.

When questioned about failing to do such testing, vaccine advocates systematically claim that there is a good reason that these double blind studies are not conducted; they claim that (1) it’s not needed, and (2) that it would be unethical to withhold a vaccine from an individual because it leaves the individual at risk. There are obvious flaws with these arguments.

Any medical intervention that will be administered to millions has no business going through less-rigorous safety studies.

The injuries reported in VAERS database prove that the safety testing is inadequate.

During safety testing, placebo studies are in fact done, where the individuals receiving the placebos are known to be at risk of contracting the disease.

Several vaccines on the schedule, perhaps varicella (chicken pox) being the most egregious, are for diseases that a not seriously dangerous and pose no risk or disability or death. Performing a double-blind study for the varicella vaccine was and remains obvious.

In addition, other serious problems with the so-called safety studies include:

A number of studies use all ingredients EXCEPT the antigen as the placebo. This means that any potential issues with the non-antigen ingredients in the vaccine (such as aluminum-based adjuvants included to elicit the immunoresponse, and other known neurotoxins and carcinogens) will be masked in the results.

A number of studies have been submitted for approval based on safety testing done on the antigen alone, with no placebo, and never based on the full cohort of what is administered (the antigen + adjuvant etc. solution).

Although it has been removed from most vaccines on the childhood schedule, mercury (thimerosal) remains in the vast majority of flu shots administered today. The flu shot is now recommended annually per the CDC schedule. Heavy metal such are mercury and aluminum are known severe neurotoxins. (Thimerosal is a preservative that makes the manufacturing process cheaper; it is not in the more expensive single-dose vials).

Even if a double-blind study was conducted, the manufacturers hand-pick which groups get included in their official results submissions to regulators (i.e., those with the lowest number of reported issues). They also include exclusion criteria that does not match the recommendation for the general public. For example, the Gardasil clinical trials had numerous exclusion criteria. Not allowed to participate with people severe allergies, prior abnormal Pap test results, over four lifetime sex partners, a history of immunological disorders and other chronic illnesses, reactions to vaccine ingredients (including aluminum, yeast, and benzonase), or a history of drug or alcohol abuse—yet Merck now recommends Gardasil for all of these groups.

There is a serious ethical question of whether certain subjects are aware they are part of a safety study. Many girls given the Gardasil in the UK as part of the initial study were told that the vaccine had already been tested and proven safe, when in fact they were subjects of the safety test.

Manufacturers can provide misleading information in their package inserts to hide safety concerns. For example, Merck’s Gardasil product circular combines the control and saline control groups into a single group, making it appear that the control group issues are half as serious as they are. Up to page 6 there are three groups listed, but on page 6, the Systemic Adverse Events are suddenly combined for the two groups.

What used to be called “side effects” and now referred to as “new medical issues” as though the vaccine has nothing to do with the injury.

There is an inherent problem with trusting pharmaceutical companies to evaluate and accurately report the risk of using their own products. (Consider the Vioxx tragedy.) A 2017 article in Slate titled “What the Gardasil Testing May Have Missed” exposes serious flaws in Merck’s clinical trials for its HPV vaccine, which made it considerably harder to adequately assess risk; it is a sobering picture of what happens when pharmaceutical giants are left unchecked.

Moreover, not only have the individual vaccines not been adequately tested for safety, the current practice of administering multiple vaccines simultaneously has never been tested in any way. Public video of the CDC’s 2018 Advisory Committee on Immunization Practices’ meeting, discussing and voting on whether to add the new Hepatitis B vaccine to the vaccine schedule, perfectly demonstrates how vaccines are rubber stamped for use in all American children:

Dr. Hunter: Is there any comment on using this vaccine at the same time with other adjuvanted vaccines?

CDC: We have no data to make a recommendation one way or the other.

CDC 2: So, just to sort of put this in the context of other vaccines, while pre-clinical studies were not done using these vaccines simultaneously, our general approach to immunizations is that they can be given at the same time in different limbs.

Dr. Hunter: Are adjuvanted, multiple adjuvanted vaccines used in Europe or other markets?

Dr. Ward: Not to my knowledge

CDC: Okay, I think unless there’s any further discussion, we will take a vote on this recommendation [… ] So the voting is completed and it is unanimous to support this recommendation.  And does anyone around the table have any comments they wish to make about their vote?

Note here that the reservations were voiced only AFTER the recommendation had already been approved. How is this help American children? Where is the debate?

Dr. Stephens: So, just a slight reservation. I think this is a huge advance and a step forward. I am concerned about that signal. That myocardial infarction signal. I am concerned about the user of this new adjuvant and certainly urge us to continue to look at the post-marketing data carefully.

Dr. Hunter: Just a question about that. How soon would we be getting that post-marketing data update here?

CDC: There’s two kinds of data. The vaccine safety datalink data will require people to be using the vaccine to develop substantive database, and Dr. Sun, do you want to comment on the post-marketing data that the FDA is requiring?

Dr. Sun: I think for the myocardial infarction study…the date is likely for May 31, 2020. There will also be studies looking at autoimmune diseases as well as herpes zoster. And there will be a pregnancy registry as well. That’s’ all included in the post-marketing surveillance.

CDC: Thank you.

What is post-marketing surveillance data? It’s the adverse events reported by Americans after getting the vaccine.