Top Vaccinologist Admits Vaccines Are Not Properly Tested for Safety: 'The New England Journal of Medicine'

"Prelicensure clinical trials have limited sample sizes [and] follow-up durations" and "there are not resources earmarked for postauthorization safety studies," Dr. Plotkin and colleagues admit.

In a groundbreaking revelation, vaccinologist Dr. Stanley Plotkin, the widely recognized inventor of the rubella vaccine, and his colleagues have conceded significant gaps in vaccine safety studies.

The admission, which contrasts sharply with decades of assertions about the safety of vaccines, was highlighted by attorney and vaccine safety advocate Aaron Siri in a detailed Twitter (X) thread.

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The Admission

The article in question, published in The New England Journal of Medicine (NEJM), acknowledges the shortcomings in both pre-licensure and post-licensure vaccine safety studies.

Dr. Plotkin and his co-authors admitted that “[p]relicensure clinical trials have limited sample sizes [and] follow-up durations” and that “there are not resources earmarked for postauthorization safety studies.”

This starkly contrasts with the long-standing position of the medical community, which has often portrayed vaccines as among the most thoroughly tested medical products.

Historical Context

Siri contextualized these admissions against a backdrop of historical assertions by leading figures in vaccinology.

He recalled pediatrician and infectious disease doctor Dr. Paul Offit’s statement: “I think we should be proud of vaccines as arguably the safest, best tested things we put in our body.”

Siri highlighted the decades-long struggle of parents of vaccine-injured children and other parties who contested these claims, often facing significant pushback from the medical community.

In 2018, Siri deposed Dr. Plotkin, during which he revealed substantial evidence pointing to the lack of comprehensive vaccine safety trials.

Siri noted that following this deposition, Dr. Plotkin aggressively advocated for more robust safety information on vaccine package inserts and worked to ensure vaccine hesitancy was labeled as a global threat by the World Health Organization (WHO).

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The Current Landscape

Siri emphasized that these efforts did not translate into effective safety measures, citing Dr. Plotkin’s failure to hide the truth about the absence of proper safety studies.

“Their only option is to try and co-op the truth they have lied about for decades by now admitting that the studies to show vaccines are safe do not exist,” Siri remarked.

He underscored the deceptive nature of the recent admissions, suggesting that the real agenda of Dr. Plotkin and his disciples remains unchanged.

“Their goal is to protect the products they have spent their careers defending and worshipping and that have brought them fame and riches,” Siri stated.

Key Admissions from the NEJM Article

The NEJM article contained several significant admissions, noted by Siri:

• “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.”

• “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.”

• “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 postauthorization 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.”

• “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.”

• “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.”

• “[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.”

Siri provided pointed commentary on each of these admissions, highlighting the consistent gaps and failures he has long criticized.

He stressed that these acknowledgments, while significant, do not absolve decades of misinformation and inadequate safety practices.

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Moving Forward

Siri called for an open and collaborative approach to genuinely studying vaccine safety.

He proposed convening a bipartisan panel to review existing studies and design new ones transparently.

“If they are really interested in the truth about what injuries vaccines cause and the rate at which these injuries occur, then they should welcome convening a bipartisan panel,” Siri suggested.

Despite his criticisms, Siri expressed a willingness to work with Dr. Plotkin and his colleagues to ensure the safety of vaccines.

“To be fair, I will email all four of them to request a meeting to review existing science and design studies mutually agreed upon. If they are really interested in vaccine safety, they should welcome that,” he concluded.

The admissions from Dr. Plotkin and his colleagues mark a significant moment in the ongoing debate about vaccine safety.

Siri’s detailed analysis and historical context provide a compelling narrative that challenges the longstanding assertions of the medical community.

As the conversation continues, transparency and rigorous scientific inquiry remain crucial to addressing public concerns and ensuring vaccine safety.

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