In a surprising twist, Dr. Stanley Plotkin, widely regarded as the father of modern vaccinology, co-authored a paper in the New England Journal of Medicine.One (NEJM) acknowledged significant gaps in vaccine safety research and called for increased funding to address these shortcomings.
This recognition comes after decades of the medical community insisting that vaccines are among the most thoroughly studied and safest medical interventions. In a paper titled “Funding Vaccine Safety Science After Authorization,”2 They make a series of revelations that substantiate concerns long raised by vaccine safety advocates. Aaron Siri, managing partner at the New York law firm Siri & Glimstad, wrote in a commentary:three
“Wow. After decades of claiming that vaccines are the best-studied product on the planet, Dr. Stanley Plotkin and his vaccinologist disciples just wrote an article admitting the exact opposite.
They just admitted that the vaccine was poorly studied, both pre- and post-approval. For example, they admitted that 'pre-approval clinical trials were limited in sample size and follow-up period' and that 'there were no resources allocated to post-approval safety studies.'”
Key Admissions Officers Spotlight Lack of Vaccine Safety Research
One of the most striking admissions in the paper is that pre-licensing clinical trials for vaccines are inadequate to assess safety. The authors write:4
“Post-licensure studies are needed to fully characterize the safety profile of a new vaccine, as pre-licensure clinical trials are limited in sample size, follow-up duration, and population heterogeneity. It is important to investigate adverse events following immunization (AEFIs) not detected in clinical trials to determine whether they are causal or coincidental to vaccination.”
This contradicts previous claims by vaccine supporters that clinical trials provide strong evidence of safety before approval. The admission that these trials have a limited follow-up period is particularly noteworthy, as critics have long argued that the potential long-term effects of vaccines are not adequately studied before they are approved and recommended for widespread use.
“Let me translate that,” Siri wrote. “The clinical trials that children rely on to get vaccines approved are useless from a safety perspective. They’re virtually placebo-controlled, typically only reviewed for safety a few days or weeks after the shot, and often have too few participants to measure anything of value.”5
The NEJM article states that there is currently no dedicated funding stream for post-approval vaccine safety studies in the United States. “Although the Advisory Committee on Immunization Practices (ACIP) recognizes the need, there are currently no resources for post-approval safety studies beyond the annual budget that must be approved by Congress each year,” the authors write.6
The lack of consistent and dedicated funding is one reason why many important safety questions remain unanswered years or even decades after vaccine introduction. The authors acknowledge that “advancement of vaccine safety science has been understandably slow,” citing delayed epidemiological evidence and an incomplete understanding of biological mechanisms as key factors.7 But Siri says:8
“It's brazen to pretend that those who have been calling for this research for decades haven't been ignored or attacked, and it's brazen to pretend that there are already countless studies showing that what I mentioned above doesn't exist… (And) it's brazen to pretend that parents' groups have been screaming about this (funding) issue for decades and haven't been ignored or attacked.”
'Insufficient evidence' to determine whether 76% of vaccine-related health outcomes are linked to shots
In a particularly telling passage, the paper notes, “In 234 reviews of various vaccines and health outcomes conducted from 1991 to 2012, the IOM found that in 179 (76%) of the relationships examined, there was insufficient evidence to prove or disprove a causal relationship, underscoring the need for more rigorous science.”9
This statistic is astonishing. In more than three-quarters of vaccine-related health outcomes studied by the Institute of Medicine (now the National Academy of Medicine), there was insufficient evidence to determine whether vaccines were causally related. This runs counter to repeated assurances that vaccine safety is an established science.
The paper also notes that for known adverse reactions to vaccines, the biological mechanisms are not understood, including serious conditions such as Guillain-Barré syndrome associated with influenza vaccines and myocarditis associated with mRNA COVID-19 shots.
Experts have long called for unbiased research to understand the impact of vaccines on children’s health, but the reality is that public health agencies and vaccine advocates have no interest in finding out the truth. Siri wrote:10
“If they really care about the truth about the injuries that vaccines cause and the rates at which they occur, they should welcome the convening of a bipartisan commission to first review all the concerning research and the robust data that already exists on this topic—often done by scientists who aren’t funded by the drug companies. And together, we can design additional studies and conduct them publicly so that everyone can live with the results.
… Plotkin and his company should welcome the research showing that vaccines did not contribute to the rise in chronic childhood diseases, most of which are immune-mediated. In the early 1980s (when the CDC recommended a 7-shot routine for children), chronic diseases in children increased from 12% to over 50% today (when the CDC recommended a 90-shot routine for children).
And I think they would welcome such research if they could show that vaccines don't cause these harms. The reality, unfortunately, is that there are already studies that (as they know) show that vaccines contribute to these increases. But in any case, their goal is not to actually study safety. Rather, it's to prove the previous assumption that vaccines are safe and harms are 'rare.'”
Acknowledging significant gaps in vaccine safety science, Plotkin and his co-authors propose increasing funding by tapping into the Vaccine Injury Compensation Program (VICP) trust fund, which they note was generating a $4.3 billion surplus as of April 2023, from an excise tax on vaccines.11
However, it is important to note the authors’ motivations for proposing this change. They express concerns about “high levels of vaccine hesitancy” and argue that the slow progress of vaccine safety science has “negatively impacted vaccine acceptance.” In other words, their primary goal is to increase public confidence in vaccines, not to critically examine safety issues with an open mind.
Failure to acknowledge decades of lies, gaslighting, and fraud
Siri points out that the NEJM paper’s recognition directly contradicts decades of medical community scepticism. He writes:12
“For decades, the medical community has argued that vaccines are the most thoroughly studied products we have ever put into our bodies. For example, Dr. Paul Offit said, 'I think we should be proud that vaccines are the safest and best-tested products we are putting into our bodies.'”
But Siri claims that parents of children injured by vaccines and others who have raised concerns about inadequate safety research have been “shunned and attacked by the medical community and health care establishment” for years. The paper is a belated acknowledgement of what these advocates have always said, but with questionable motives.13
“Plotkin and his disciples realized that they could not sorcery the public. They could not hide the truth. So their only option was to cooperate with the truth that they had lied about for decades and admit that there were no studies showing that vaccines were safe.
But in admitting that, they conveniently fail to acknowledge that for decades they have lied, gaslighted, and defrauded (and I don’t use that word lightly) the public by claiming that vaccines are the most thoroughly safety-tested products on the planet. And by claiming that no stone has been turned over when it comes to vaccine safety.
… their real intention is clear, not to study vaccine safety, but to confirm what they already believe. This is very clear in their article, which admits that no study has been conducted, yet in the same breath writes that serious vaccine harm is ‘rare.’ But if no study has been conducted, how could they know?”
Siri also points out that the authors ignore existing studies that found evidence of harm from vaccines or vaccine ingredients.14 He argues that a truly unbiased study should take this evidence into account rather than starting from the assumption that serious side effects are rare.
Studies have shown that vaccinated children have higher rates of disease.
A study by Dr. Paul Thomas and James Lyons-Weiler looked at health outcomes for children who were vaccinated and those who were not in a pediatric clinic over a 10-year period. Dr. Thomas had his medical license suspended because he advocated for informed consent for vaccinations.
The study, published in the International Journal of Environmental Research and Public Health, found:15 We found that vaccinated children had higher rates of a number of health problems compared to unvaccinated children. These included:
asthma | allergy |
eczema | sinusitis |
gastroenteritis | Respiratory infection |
Otitis media | conjunctivitis |
Breathing problems | Behavioral problems |
In particular, ADHD was observed in a minority of vaccinated children but not in unvaccinated children. The study also reported lower rates of autism spectrum disorder and ADHD in this clinic compared to the national average. The authors suggested that unvaccinated children in this clinic were at least as healthy as vaccinated children, if not healthier.16
The researchers also stressed the need for more independent research on the topic, without potential conflicts of interest from the vaccine industry, to better understand the link between vaccination and child health outcomes.
The proposed solution raises questions about the true motivation.
For years, those who have raised concerns about vaccine safety have been dismissed as “anti-science” or accused of endangering public health. The NEJM paper shows that their core criticisms, including those about inadequate safety research, are valid.
The publication of this paper represents an important shift in the public discourse on vaccine safety. By acknowledging major gaps in safety research and the slow progress of vaccine safety science, Plotkin and his co-authors have validated concerns previously dismissed by much of the medical community.
But the proposed solution and the author’s stated motivations raise serious questions about whether this represents a genuine shift toward a more critical examination of vaccine safety, or simply an attempt to restore public trust. Siri continues:17
“These people have the audacity to conclude a priori that harm is 'rare,' then ignore all existing research showing harm, and then raid the Federal Vaccine Injury Compensation Fund and pay themselves and their compatriots hundreds of millions of dollars to conduct research to confirm their a priori conclusion that harm from vaccines is 'rare,' all the while ignoring studies that already show serious harm.”
What is clear is that the oft-repeated claim that vaccines are “the most thoroughly studied medical intervention” is no longer credible. As this paper demonstrates, there is still much to learn about vaccine safety, and acknowledging this is an important step toward informed consent and transparent vaccination policies.
