FDA’s Vaccine Safety Lie

Why Buildings Have Stricter Quality Controls than Pediatric Vaccine Trials

by James Grundvig

Imagine President Donald Trump, in his past life as a real estate developer, learning that his new building had its structure compromised — the concrete didn’t meet design strength. Wanting to get to the bottom of the issue, he would direct his team to investigate the problem and report back to him. The findings, however, would shock him.

The contractor followed the “guidance” of the design team, but not the minimal code set by the city or the concrete industry. Trump would learn such guidance gave the contractor leeway to follow his whims on the design criteria of the specifications. That would cost Trump’s project time and money in remediation, and lawsuits would fly out the door.

But since no construction project in North America gives the contractor only “guidance” on what codes to follow — they must follow all that apply — then it’s truly stunning to learn this is what the FDA has been directing vaccine manufacturers to do for decades: Follow agency guidance, not a strict code, minimal requirements, specifications or regulations when it comes to the design and execution of vaccine safety studies.

Vaccine manufacturers are free as a bird. They can virtually do what they want. But how can that be?

It’s all in the FDA’s Biologics Division, in the words that gives “Guidance” for the different vaccine clinical trials, such as, “Guidance for Industry: For the Evaluation of Combination Vaccines for Preventable Diseases: Production, Testing and Clinical Studies.” Or how about, “Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines.”

If an architect or engineer ever used the word “consideration” in their specification on what design criteria to build to, the contractor would take liberties and not worry about exact compliance with any specification or regulation. They would just build fast, cheap, and dirty. And that is what vaccine makers have been doing for years.

So why does the FDA not write real codes and specifications, with strict standards and protocols for the vaccine makers to follow, achieve, and adhere to when conducting vaccine clinical trials?

Vaccine Clinical Trial Propaganda 101

According to the FDA, the word “placebo” can get bandied about on vaccine safety studies. A placebo for vaccines is not the same placebo used in drug trials. Vaccine makers are not obligated to use a real placebo, like saline, since guidance gives them an option and not a firm standard to follow. This leeway allows Big Pharma to use an “active comparator” vaccine, such as another similar vaccine or the clinical trial vaccine with the deactivated disease removed, as a “control” instead of a true placebo (saline).

Worse, the FDA allows — perhaps encourages — vaccine makers to freely use the word “placebo,” when in fact they should be forced to use the word “control” when they use the comparative vaccine during safety trials. But time and again, when one reviews the literature, such as the 28-page Gardasil package insert that states only “320 people” were given the saline placebo, or less than 9% of the control group, with the only reactions monitored for the true placebo group being mild, local reactions, such as redness or swelling.

So the Gardasil clinical trial is a sham. Out of the 3,690 “controls,” only 320 received the saline placebo. That meant 3,370, or 91.33%, were jabbed with the comparative vaccine, which was laden with aluminum at “double the amount in every other vaccine.”

No wonder New York moms are suing the state on forced Gardasil injections and that Judicial Watch and other law firms have jumped into the fray.

If only the lawyers understood the nuances of quality control inspections and quality assurance programs they would see what the vaccine safety trials really are — a ruse under the FDA guidance platform.

With the FDA, which is supposed to be the backstop to food, drug, and biologics safety testing and inspection, allowing vaccine makers free reign, to use their own judgment and discretion when it comes to generating vaccine safety trials we all lose. That is because Big Pharma then falsely claims that the tested vaccine has about the same side effects as the placebo, and thus is safe, when it should in fact be made to use the word control and describe in granular detail what the “active comparator” vaccine includes. Until the vaccine makers are forced to conduct true “vaccinated vs. placebo” clinical studies, Americans lose out to big industry with the problem about specific vaccines safety and efficacy hidden from public view.

This FDA shell game masks the truth about vaccines safety, when in fact they are likely causing more damage than advertised. So what the Gardasil package inserts state and what the Gardasil lawsuits are beginning to discover the safety trials for the HPV vaccine is an abject lie, a charade that falsely promotes vaccines are safe when no quality control exists to identify real reactions or side effects to the vaccines being tested.

What Needs to Happen

When a comparative vaccine is used in a safety trial, the disease has been removed, but all the toxins that are loaded into the trial vaccines, like thimerosal and aluminum adjuvants, get injected into the control population. This is outrageous and perpetuates the lie.

So what Big Pharma has produced over the years and decades, with the FDA’s full approval, have been cosmetic vaccine safety studies that falsely show as many side effects as the so-called placebos.

The way vaccine clinical trials are conducted today needs to end. Full stop. The word “guidance” needs to be deleted from all literature, and the existing protocols need to be replaced with strict design criteria and specifications. Vaccine trials need to be run by third party, independent science teams with zero industry conflicts. Post haste, President Trump needs to remove vaccine safety trials and quality control inspections from the FDA and its Biologics Division.

The longer President Trump waits to launch a Vaccine Safety Commission the more the vaccine clinical trial lie will continue to be used to sell and cajole the American people that all is well with the latest vaccine that has been tested and found “safe” for consumer use, when in fact it has not.

The FDA guidance program for vaccine safety trials is a disgrace of the highest order. It’s not science. It circumvents quality assurance. And it endangers all Americans, especially fetuses and pregnant women, newborn babies, and children who sit helplessly in the crosshairs of the mounting toxic vaccines.

Part II —Coming Next Week: “Broken Onsite Inspections at Vaccine Plants”