Del Bigtree, the CEO of the Informed Consent Action Network (ICAN), triumphantly proclaimed, “We win,” following the admission from Dr. Stanley Plotkin that vaccines haven’t been adequately tested for safety. Bigtree addressed the published paper authored by Dr. Plotkin and others with stunning admissions regarding the lack of safety testing for vaccines that have been declared as “safe and effective” by the medical establishment for decades.

Bigtree reviewed a list of statements from the published paper that confirm the reporting from ICAN and The HighWire has been factual, despite reports against the non-profit for spreading “misinformation.”

Dr. Plotkin and his co-authors first admission from the paper was:

“[T]he widespread vaccine hesitancy observed during the COVID-19 pandemic suggests that the public is no longer satisfied with the traditional safety goal of simply detecting and quantifying the associated risks after a vaccine has been authorized for use.”

This statement claims that the public has been fine with being involved in the safety testing of vaccines after the product is brought to market. The CDC lays out the clinical safety testing steps before a vaccine is authorized for use on the market but fails to mention the short time frame of the studies. Bigree points out that individuals and family members of vaccine-injured people were never okay with the risk assessment protocol happening after the mass distribution of the medical product for public use.

“Postauthorization studies are needed to fully characterize the safety profile of a new vaccine since prelicensure clinical trials have limited sample sizes, follow-up durations, and population heterogeneity.”

In simple language, the paper’s authors admit that the clinical trials used to authorize the vaccine for public distribution are inadequate to determine safety. Furthermore, the statement admits that there are no post-authorization studies to analyze the risks of the vaccines after the public starts receiving the product.

Bigtree said the pre-licensure clinical trials are “useless,” because the sample sizes are too small to be meaningful, there is almost never a placebo control group, and safety is only reviewed for days or weeks after the vaccine is administered. 

“It is critical to examine adverse events following immunization (AEFIs) that have not been detected in clinical trials, to ascertain whether they are causally or coincidentally related to vaccination.”

“When they are caused by vaccines (vaccine adverse reactions), the risk attributable to vaccination and the biologic mechanism must be ascertained. That science becomes the basis for developing safer vaccines, if possible, and for determining contraindications to vaccination and the compensation that should be offered for AEFIs.”

Bigtree said this is what the medical establishment claimed was being done for decades. Certainly, causality should be investigated and determined if adverse reactions occur following an injection. The public trusts that this kind of causality has been researched, ruled out, or determined as a “rare” side effect. Aaron Siri, lead attorney for ICAN, also stated that this is obvious and researchers have falsely stated for decades that this research and analysis was being conducted.

“Currently in the United States, when the Advisory Committee on Immunization Practices (ACIP) recommends a new routine vaccine, the only automatic statutory resource allocations that follow are for vaccine procurement by Vaccines for Children (VFC) and for the Vaccine Injury Compensation Program (VICP). Although the ACIP acknowledges the need, there are currently no resources earmarked for post-authorization safety studies beyond annual appropriations, which must be approved by Congress each year.”

“Progress in vaccine-safety science has understandably been slow — often depending on epidemiologic evidence that is delayed or is inadequate to support causal conclusions and on an understanding of biologic mechanisms that is incomplete — which has adversely affected vaccine acceptance.”

Bigtree asserted that the authors are gaslighting once again, because the real problem is that adequate pre-licensure trials are not being conducted. He also slammed the authors and medical establishment for only bringing up this point as a barrier to vaccine acceptance and uptake rather than a genuine concern for the safety of the products approved for widespread public use.

“In 234 reviews of various vaccines and health outcomes conducted from 1991 to 2012, the IOM found inadequate evidence to prove or disprove causation in 179 (76%) of the relationships it explored, illustrating the need for more rigorous science.”

Bigtree said this is another obvious point that has been lied about for decades. He also said this information came directly from an ICAN paper, but the paper failed to properly cite the source.

The admission that vaccines need more “rigorous science” also contradicts the health authorities that claim on their websites that vaccines already undergo “rigorous” testing. This includes the FDA, CDC, and the WHO.

“Identifying the biologic mechanisms of adverse reactions — how and in whom they occur — is critical for developing safer vaccines, preventing adverse reactions by expanding contraindications, and equitably compensating vaccinees for true adverse reactions.”

Bigtree said they are pretending to not have “shamelessly ignored or attacked” individuals like himself that called for more studies. He also pointed out that a “mountain” of studies already exist regarding the adverse reactions of vaccines.

“[T]he budget for vaccine-safety monitoring at the CDC (which is responsible for the majority of U.S. federal efforts) has remained stagnant … at about $20 million per year” which they write is an “inadequate level of funding.”

“The public [now] also wants public health authorities to mitigate and prevent rare but serious adverse events – which no longer seem rare when vaccines are given to millions or billions of people.”

Bigtree and ICAN criticized Dr. Plotkin and strong vaccine advocates for seeking to approve studies that lead to predetermined conclusions that all vaccines are safe, except for “rare” serious side effects. They argue that the only motive for more rigorous studies is to counter the increasing vaccine hesitancy following the failed COVID-19 vaccination program. Bigtree added that if the authors are “well-meaning,” they should meet with attorney Aaron Siri to discuss existing studies.

The June 11 HighWire report also includes a clip of Siri questioning Dr. Plotkin under oath, in which Plotkin makes similar admissions regarding the lack of long-term safety studies for licensed vaccines.

In Siri’s statement on X, he said the motivation behind these admissions is among other things to “raid the federal vaccine injury compensation fund to presumably pay themselves and their compatriots hundreds of millions of dollars to conduct the studies that would, no doubt, seek to confirm their prior conclusion that vaccine harms are “rare,” while ignoring the studies that already show serious harm.”

In his statement, Siri also included a quote from Dr. Paul Offit: “I think we should be proud of vaccines as arguably the safest, best-tested things we put in our body.”

Siri has previously discussed The 1986 National Childhood Vaccine Injury Act (NCVIA) and the inherent harms of giving manufacturers immunity from liability. In this Arizona government committee hearing, he discusses informed consent and why it is needed for medical products.

Del Bigtree, in his statement on The HighWire, said they admitted that it is “an absolute guess” as to whether vaccines are safe. “We win. This is over. Stop mandating this product on people!” he exclaimed.