The Surprising Truth: No Saline Placebo Controls for Licensure
According to Aaron Siri, the central, categorical truth uncovered from the FDA’s own files is this: not a single routine injected childhood vaccine on the current CDC schedule was licensed based on a clinical trial that compared it to a true, inert saline placebo. His firm’s years of research confirm this holds true not only for the vaccines currently in use but also for the earlier versions of those vaccines that were later used as “controls” for newer products. This means the entire daisy chain of licensure, stretching back decades, lacks a genuine, inert placebo-controlled trial at its foundation.
“there has never been a routine injected childhood vaccine that was licensed based on a placebo control trial. Nor were any control vaccines used for those trials anywhere down the chain licensed based on a placebo control trial. And the proof is right here.”
The Deposition That Shook the Vaccine World
In a remarkable legal encounter, Aaron Siri deposed Dr. Stanley Plotkin, a figure often described as the “world’s leading vaccinologist.” The expectation was that Dr. Plotkin would present a “mountain of science” to substantiate vaccine safety claims. The outcome was stunningly different. Siri recounts giving Dr. Plotkin a “second chance” after the deposition, formally subpoenaing him to produce the body of clinical trial data supporting vaccine safety. Instead of responding with the requested evidence, Dr. Plotkin reportedly hired a lawyer to quash the subpoena and never produced a single document.
Siri notes that following this encounter, Dr. Plotkin took several actions, including successfully campaigning to have the words “brain damage” removed from the MMR vaccine information statement. He also created an online library at the Children’s Hospital of Philadelphia to help other vaccinologists prepare for legal questioning—a library that, in Siri’s view, inadvertently reveals the profound weakness of the available safety data.
“he responded by getting a lawyer and moving in a separate court to to squash that subpoena has never produced a single document.”
If Not Saline, Then What? The Shocking “Controls”
If vaccine manufacturers didn’t use inert saline placebos in their pre-licensure trials, what did they use? The answer, found in FDA documents, is a range of other biologically active substances. This methodology, which Bigtree bluntly calls “rigging the trial,” can make a new product appear safe by masking its adverse events. If the “control” substance causes a similar number of reactions as the vaccine being tested, the new product’s harms are effectively erased by comparison.
Here are some of the most striking examples from the source material:
• Another Experimental Vaccine: For Prevnar 7, the very first vaccine licensed for routine use in babies at 2, 4, and 6 months of age, the control group received another investigational meningococcal vaccine that had not been approved for safety.
• Known Neurotoxins: In the trial for the Hepatitis A vaccine (Vaqta), the substance given to the “placebo” group contained a cocktail of known neurotoxins, including aluminum (AHS) and the mercury-based preservative thimerosal.
• The Full “Witch’s Brew”: For the original Gardasil vaccine, the “placebo” given to over 10,000 girls was not saline. It was the company’s proprietary aluminum adjuvant—a known neurotoxin used in animal studies to deliberately induce autoimmune disease—or the entire vaccine carrier solution minus the virus antigen.
Debunking the “It’s Unethical” Defense
A common defense for not using saline placebos today is that it would be unethical to withhold a proven, effective vaccine from a control group of children. However, Siri points out that this argument completely falls apart when applied to the very first vaccines of their kind ever licensed. For products like the first Hepatitis A vaccine or the first HPV vaccine, there was no previously licensed vaccine to withhold. Therefore, no ethical barrier prevented the use of a simple, inert saline placebo.
Despite this, the manufacturers still chose not to. In the trial for the Havrix (Hepatitis A) vaccine, the control group received the Hepatitis B vaccine. For the original Gardasil trial, the control group received the aluminum adjuvant. This reveals a conscious choice was made to avoid a true placebo comparison even when it was ethically permissible and scientifically necessary to establish a true safety baseline. The recent COVID-19 vaccine trials, which did use a saline placebo control, serve as definitive proof that such trials are entirely possible when manufacturers choose to conduct them.
A Shift from “Belief” to Critical Thinking
The overarching theme of the discussion is that vaccines have been treated less like a branch of evidence-based science and more like a “religion” or “ideology.” Siri makes a crucial distinction between “believing” in vaccines and critically “thinking” about them by demanding and examining the primary data. This is not an anti-vaccine argument but a pro-science mandate. Science is not a set of beliefs to be defended; it is a rigorous method of inquiry. The demand for placebo-controlled trials is a call to return to the fundamental principles of evidence-based medicine, which, the evidence suggests, have been uniquely abandoned for this one class of pharmaceutical product.
“If anybody says I believe in the vaccine, you got to stop and say, ‘Listen, stop believing, man. Start thinking.'”
A Question of True Informed Consent
The information uncovered from the FDA’s own files suggests that the scientific foundation for vaccine safety testing is not what most of the public, and perhaps even most doctors, have been led to believe. The bedrock “gold standard” of a true placebo control seems to be missing from the licensure of every routine injected childhood vaccine. This doesn’t provide a final answer on vaccine safety, but it raises a profound question that cuts to the heart of medical ethics: If the gold standard of safety science was never truly applied, can parents really give fully informed consent?
