How CDC and FDA Defrauded the American Public about Serious Vaccine Harms
Via numerous lawsuits, Aaron brought many deeply buried, politically inconvenient facts to light, and he is very factual, which is uncommon for vaccine books. They are usually emotional and far too critical of vaccines, or far too positive, with little in-between, which is where the truth is.
The value of lawyers cannot be overestimated. Nothing hurts like the truth about healthcare, which is why we badly need lawyers to dig it out. When drug policy researcher Alan Cassels reviewed my 2025 book, How Merck and Drug Regulators Hid Serious Harms of the HPV Vaccines, he concluded that “If you want the real truth about drugs, don’t ask doctors – ask lawyers.”
Another quote on my book cover is from Martin Kulldorff, the current chair of the Advisory Committee on Immunization Practices (ACIP) at the US Centers for Disease Control and Prevention (CDC): “Drugs and vaccines can heal and save lives, but also harm. That puts our lives in the hands of pharmaceutical companies. Can we trust them? In this well-documented book, the clear answer is: NO.”
It is essential to understand this. We know very little about the harms of vaccines because most of the data come from substandard and flawed trials performed by drug companies, which leave out important adverse events from their publications and avoid, with virtually no exceptions, to compare their vaccines with a placebo.
As an expert witness in a lawsuit against Merck, I read 112,452 pages of confidential study reports and uncovered multiple instances of scientific misconduct in which the drug agencies were complicit. It turned out that Gardasil, an HPV vaccine, causes serious and persistent neurological harms, which drug regulators have denied.
Aaron explains right from the start why vaccines are sacrosanct. People never say they believe in cars but many say they believe in vaccines, without having the data needed to provide an informed opinion. I found the same when I analysed BMJ articles about Kennedy’s much-needed vaccine reforms; it was all about faith, not about science.
Aaron has used lawsuits to demonstrate that vaccinologists have a self-reinforcing belief system whose dogmas do not stand up to scrutiny in court. His takedown of Stanley Plotkin, the “high priest” of vaccines, during a deposition is a masterpiece in exposing that the emperor has no clothes when claiming that childhood vaccines are safe and have been carefully tested.
Plotkin was unable to understand why his earnings of hundreds of millions of dollars from royalties and his close alignment with the interests of the industry could influence his views on vaccines. He didn’t know that safety monitoring in certain trials only lasted 4-5 days after vaccination, which is way too short to capture autoimmune adverse events. Worst of all, Plotkin stated that certain vaccines don’t cause certain harms, or he stated that they were rare, without having any evidence in support of his wishful thinking.
In 1986, manufacturers were granted almost complete immunity from liability for injuries caused by vaccines. This meant they had no incentive to ensure that vaccines are safe before they brought them onto the market. People can file claims against the Department of Health and Human Services (HHS), which is therefore not interested in having any of its agencies, including the CDC and the Food and Drug Agency (FDA), publish studies demonstrating vaccine harms – a perfect set-up for the industry.
HHS was required to submit to Congress biennial vaccine safety reports but a lawsuit revealed that it had not sent a single report in 30 years.
HHS was also required to make recommendations to improve vaccine safety, but after a single report decades ago, the only thing it did was disband the task force that was responsible for this. Aaron’s group also found out, after having complained in court about redactions in emails, that the CDC had a cozy relationship with Big Pharma and made policies about vaccine safety with the companies while refusing to work with citizen groups concerned about safety.
Vaccines have saved millions of lives. Smallpox is estimated to have killed around 500 million people in the last 100 years of its existence and the vaccine eradicated the disease. However, vaccine zealots claim that also currently, vaccines save millions of lives in the Western world, which is not true. Aaron shows that there was a huge decline in infectious disease mortality between 1900 and the introduction of modern vaccines, which started with the diphtheria, tetanus, and pertussis (DTP) vaccine in 1949. In the year before the introduction of each of 12 childhood vaccines, only about 5,000 people in total died from these diseases in the United States, which means that the combined life-saving effect must have been very small.
The DTP Vaccine
The DTP vaccine is the most used vaccine in the world, but Peter Aaby and other Danish researchers found in several studies that the vaccine increased total mortality in Guinea-Bissau. When Aaron asked UNICEF if they had evidence that the opposite was true, they referred to an inconclusive 2014 WHO report. Astoundingly, they did not comment on Aaby’s 2017 study, which was performed to address concerns WHO raised in 2014 about his previous studies.
In 2019, Aaron asked me to review the research, which was revealing. Aaby found that the DTP vaccine doubled mortality even though all the biases he documented in his observational study favoured the vaccinated group. He also found that all studies that had analysed existing data sets collected for other purposes suffered from substantial biases that led to an underestimation of the harms.
I consider Aaby’s findings much more convincing than the WHO report, which had major issues. The authors were not allowed to meta-analyse the studies, likely because the WHO didn’t want to run a risk of receiving a systematic review that suggested that the DTP vaccine increases total mortality. Moreover, the way WHO’s experts handled the data was inconsistent and scientifically inappropriate.
Even though two of the three authors of the WHO report were senior researchers in the Cochrane Collaboration, editor-in-chief Karla Soares-Weiser and statistician Julian Higgins, editor of the 636-page Cochrane Handbook, which describes how to do reliable systematic reviews, they used vote-counting (how many studies are for and how many against?), which is a method recommended against in the Cochrane Handbook. It was truly bizarre.
Aaby published another study in 2018 that I also commented upon and which also showed an increase in mortality. Yet again, UNICEF didn’t do anything but emails exchanged with the CDC revealed that both agencies were concerned about avoiding personal exposure and not about whether a vaccine might kill children. The metric of success in the vaccine field is not survival or childhood health but vaccine uptake.
Supporting the False Narrative by Deception and Lies
Aaron provides other examples to demonstrate that our institutions are more focused on supporting the official, false narratives than on providing honest information. When studies show that vaccines increase deaths, they are by default deemed unreliable, but when the same kind of studies show that vaccines reduce deaths, they are reliable. During Covid-19, reductions in mortality were ascribed to vaccines, but when mortality increased despite continued vaccinations, the authorities pulled the data from public view. This also happened when it turned out that the more doses people received, the greater the risk of Covid infection.
Drug companies and authorities lied repeatedly by claiming that certain vaccines, e.g., against Covid, can prevent transmission. GlaxoSmithKline even tried to sell more vaccines by encouraging old people to get vaccinated against whooping cough to protect their grandchildren, but the pertussis vaccine does not prevent infection or transmission. Aaron’s firm successfully sued GSK for its false advertising.
That most childhood vaccines fail to prevent transmission makes it particularly repulsive to mandate those vaccines as a condition for school entry, but all US states mandate vaccines for school enrollment. Even the HPV vaccine has been mandated in the US, although the disease is sexually transmitted, which hopefully does not occur in the classroom. Aaron argues that the more a product needs to be coerced, the more one should be concerned about that product.
In the US, newborns get vaccinated against hepatitis B on the first day of life, even though this disease is typically transmitted by sex or drug users sharing needles. The vaccine was approved by the FDA based on a study of 147 children monitored for 5 days after vaccination, and with no control group.
When Aaron sent a legal demand to HHS about why clinical trials for childhood vaccines did not include a placebo control group, the agency lied: “Many pediatric vaccines have been investigated in clinical trials that included a placebo.” Not a single childhood vaccine on CDC’s routine schedule has been studied in placebo-controlled trials before licensure, but in a public dispute with Aaron, Plotkin’s best-known disciple, Paul Offit, claimed that all vaccines are tested in such trials before licensure. He even argued that it would be cruel to use a placebo control, so, if we accept his explanations, they mean that he, Plotkin, and their colleagues are cruel.
As Aaron soberly explains, in a placebo-controlled trial, children are left unvaccinated only for the duration of the trial. In contrast, injecting a vaccine into millions of children in an uncontrolled setting without first assessing its safety in a placebo-controlled trial is, to any objective, reasonable observer, grossly unethical conduct. Childhood vaccines are used in healthy children to benefit very few. The requirements for vaccines should therefore be much greater than for other drugs, but there are virtually none. This may be the most appalling neglect we have in all of healthcare.
Offit falsely claimed that 16 children had died in a polio trial on “placebo” as he called it but it was not placebo and the true number was 4.
Aaron documents that new vaccines for the same disease are compared with older vaccines, and when the adverse events are the same, it is concluded that both are safe. This is like saying that cigars are safe because they cause similar harms as cigarettes. He dryly remarks that “This is not something I would have ever thought to dream up,” and he holds so-called fact-checkers to the fire. They believe that the claim that routine childhood vaccines were not licensed based on a placebo-controlled trial is false but have not bothered to look up the facts in primary sources such as publicly available FDA documents.
A CNN article from June 2025 is particularly “amusing.” It listed 258 studies at the time (it now lists over 1,000) and Dr. Jake Scott from Stanford University claimed that 153 tested vaccines against placebos. But, as Secretary Kennedy made clear in his response, not one of these studies included a placebo or was otherwise relied upon by the FDA to license a vaccine on the CDC’s routine childhood schedule.
Moderna abandoned development of its RSV vaccines after placebo-controlled trials had shown more serious respiratory infections in the vaccine groups. There had been problems before. An RSV vaccine trial in the 1960s infamously sent 80% of vaccinated children to the hospital and two died. Apparently, the vaccine primed their immune system so that during an infection, helpful T cell responses were blunted and high levels of ineffective antibodies were produced, forming dangerous airway-clogging complexes.
The dengue vaccine, used in the tropics, is another example of why we cannot assume vaccines are safe. It worked well for children who had already been infected, but in other children, it increased the risk of severe disease, which can be fatal. This was only revealed because the trial was placebo-controlled and because safety was monitored for five years.
Aaron describes how virtually all serious adverse events in vaccine trials with no placebo control are dismissed by researchers on drug company payrolls as being unrelated to the vaccine, which they cannot know, as they don’t know which harms a new vaccine might cause. This type of deception was common in Merck’s Gardasil trials.
Aaron quotes a letter that references some research that links vaccines to autism, which I have reservations about that I shall not discuss here, as this issue requires rigorous reviews of the research. But I have dismissed the popular idea in anti-vaccine circles that the CDC did anything wrong in the study where they did not find any association with the MMR vaccine; I have explained why Andrew Wakefield’s retracted study in the Lancet was fraudulent, on many counts; and I have published critical comments on one of the autism studies.
Obviously, it is important to do high-quality research on this issue. Even though much of the increase in autism diagnoses is artificial, caused by lowering the bar for making a diagnosis and by increased attention, it is also a fact that cases of profound autism have increased.
It cannot be disputed that vaccines can cause serious, sometimes deadly, harms, which was confirmed in reports from the Institute of Medicine. However, our institutions have failed us badly, and a systematic review from 2014 by the Agency for Health Research and Quality is a good example of this.
The review was supposedly about vaccine safety but the real goal was to increase vaccine uptake: “increasing vaccination rates remains critically important,” which is a wrong premise for studying vaccine harms. Moreover, the authors stated that new vaccines must undergo rigorous processes before receiving approval and that they meet “stringent criteria for safety,” which is so wrong that it looks like a propaganda pamphlet from a drug company.
Aaron explains how flawed this colossal review is (740 pages). Virtually all the included studies were conducted by drug companies or by people funded by them, and the agency’s claim that they had an unvaccinated control group was wrong, as people also got vaccines in the control group.
More Dirty Tricks by the CDC and the FDA
In 2013, HHS commissioned the Institute of Medicine to review the safety of the CDC childhood schedule including the occurrence of asthma, autoimmune diseases, autism, and other neurodevelopmental disorders. The institute could not find a single study that had compared health outcomes in vaccinated children with those in children who had not received any vaccines. They revealed their bias in the conclusion, which is very odd: “There is no evidence that the schedule is not safe.” I see. So, if the brakes in a new car model have never been tested, the reassuring conclusion would be: “There is no evidence that the brakes don’t work.”
The institute asserted that it is possible to compare vaccinated with unvaccinated children by using databases such as the Vaccine Safety Datalink (VSD) established by the CDC.
It would have been easy for the CDC to do such a study but they never did, or at least never published it, if they did one but didn’t like the results. Instead, they produced a 64-page report about how such a study should be done.
When scientists using the VSD found that vaccines cause various harms, the CDC moved the database to a health industry trade association to avoid Freedom of Information Act requests and to assure that studies it approves confirm that vaccines are safe.
It would be easy to deidentify personal data and make the database publicly available but, as Aaron says, “that is not how the religion of vaccines works.”
It is very burdensome to report adverse events to the available database (VAERS) and fewer than 1% are reported. When Harvard researchers developed a system for automatic reporting, which would also provide a denominator – the number of people vaccinated – the CDC killed the project although a CDC sister agency had funded it, and the CDC refused to communicate with the researchers.
When the CDC did an analysis that revealed massive safety signals for the Covid-19 vaccines, as compared with other vaccines (using proportional reporting ratios), they lied about it. Aaron’s firm asked for the data, but the CDC claimed they had not done the analysis they had planned to do. It was only after pressure from Senator Ron Johnson (R-WI) that the CDC admitted that they had the data.
Aaron’s firm sued the CDC to get the data, which showed that the CDC’s own threshold for triggering a safety signal was blown away for numerous serious adverse events, including cardiac events, multisystem inflammatory syndrome, and deaths.
Let me explain, plain and simple: The CDC defrauded the American public. And when they launched a smartphone-based tool, V-safe, that the public could use for reporting adverse effects of the Covid vaccines, they also deceived people to an unbelievable extent. There were 10 listed symptoms that occurred within the first week after vaccination, which were those that normally occur with vaccines. The CDC omitted to include known or suspected harms of the Covid vaccines in the checklist, including myocarditis and stroke, which, in my view, is scientific misconduct.
The public could report health impact data weekly for the first 6 weeks, and after 3, 6, and 12 months. The CDC published over 40 studies based on V-safe but in all of them, health impact data were only those reported in the first week after vaccination. This is also fraud. The CDC furthermore claimed that free-text data should not be released because they contained protected personal information. This is an invalid argument, as data can be pseudonymised.
After over two years of legal demands and federal litigation, Aaron got hold of the missing data. They showed that 8% of V-safe users needed medical care after vaccination, on average 2-3 times, and 75% were urgent care, emergency room, or hospitalisation. An additional 25% reported missing school or work or being unable to do normal activities.
We cannot even trust the randomised trials, as they also grossly underestimate vaccine harms. When my wife got the AstraZeneca Covid vaccine, she became terribly ill, with insomnia, fever, severe headache, muscle aches, nausea, dizziness, and loss of appetite. She needed to stay home from work for four days. On day three, she was slow-cerebrated in a way we had never experienced before. The first 13 colleagues at her hospital department (she is professor of clinical microbiology) also became so ill from the vaccine that they needed sick leave. By definition, when you can’t work, it is a severe adverse effect. So, 100% in her department had a severe adverse effect caused by the vaccine, but in AstraZeneca’s trial report in the Lancet, only 1% had a severe adverse reaction.
I had never seen such a large discrepancy before between what a company publishes and what people experience. By far most of the subsequently vaccinated 35 people at her department also became so ill that they needed a sick leave.
The FDA also defrauds the American public. When Aaron tried to get data on Covid vaccine harms from the FDA (empirical Bayesian data), the agency refused to provide them, claiming resource constraints. His federal lawsuit has so far lasted almost three years “with no end in sight as the FDA is fighting like hell to keep that data hidden.”
The FDA is so corrupt that I call it Fatal Drug Approvals. If the FDA protected the citizens instead of the drug industry, our prescription drugs would not be the leading cause of death, ahead of heart disease and cancer.
I also call the FDA the Foot Dragging Agency. When a group of scientists asked the FDA in 2021 to provide the data submitted by Pfizer for its Covid vaccine, the FDA wanted court approval to have more than 75 years to publicly disclose this information at a pace of 500 pages a month. Aaron sued the FDA and a judge ordered release of the documents.
Even after being ordered to produce everything by a federal court, the FDA had withheld records directly tied to its emergency use authorisation of Pfizer’s vaccine, estimated to be approximately one million pages. Aaron noted that “Only those concerned about the truth seek to conceal evidence.”
The Henry Ford Study
Filmmaker Del Bigtree established the Informed Consent Action Network (ICAN), which through donations has enabled Aaron to launch multiple lawsuits about transparency and rights related to vaccines. Bigtree convinced Dr. Marcus Zervos that he should do the study that the CDC never did, comparing vaccinated with unvaccinated children. Zervos works at Henry Ford Health which had the data needed for such a study readily available.
The stated goal of the study was to rule out vaccines as the cause of long-term adverse health outcomes to reassure parents of the overall safety of vaccinations. When Aaron requested the study to be published no matter what the results showed, Zervos “looked us right in the eyes and assured us that he was a man of integrity and would publish the results, whatever the finding.”
Aaron received a study report in early 2020. The results were similar to those in other studies that had an unvaccinated control group. When he asked Zervos’ coauthor, Lois Lamerato, why they had not submitted it for publication, she replied that the higher-ups at Henry Ford did not want it to be published.
Both authors thought their study was well done, but Zervos explained to Bigtree – which he filmed with a hidden camera for his excellent documentary, An Inconvenient Study, that he didn’t want to lose his job.
After Aaron had published his book, the Henry Ford study report came to light on 9 September 2025 during a Senate hearing on “The Corruption of Science.” I explained that a ground rule in evidence-based medicine is that we should use the best available evidence when we make decisions, and as the Henry Ford study is the only one that compared unvaccinated with vaccinated kids for development of chronic diseases and that took account of confounders, it is very important that we examine this study carefully for its validity.
I did that, which I shall not repeat here, and there are also helpful replies to criticisms of the study on the homepage for the documentary film. The bottom line is that the study is above-average quality. The authors were genuinely surprised by their results and did sensitivity analyses to test their robustness. They also provided a very interesting discussion about issues that might explain their findings, which they put in context. This is what we call good science.
The vaccinated children had 2.5 times the rate of “any chronic disease,” compared to unvaccinated children. The risk was four times higher for asthma, three times higher for atopic conditions like eczema and hay fever, and five to six times higher for autoimmune and neurodevelopmental disorders. This is expected for vaccine harms. The researchers wrote that childhood infections appear to provide significant protection from atopy.
I wrote twice to Zervos and Lamerato noting that I have other data that support their findings and urging them to come out in the open and become part of history. They did not respond. They prefer to protect themselves rather than millions of children who are harmed by vaccines. I have no sympathy for such cowardly behaviour and noted in my article that they have a moral obligation to release their data in a pseudonymised fashion on a secure platform to allow other researchers to work with them for the common good.
Conclusions
Aaron warns that “history will not look kindly upon the misguided officials and individuals who seek to expel children from school, fire people from jobs, and otherwise punish people for refusing a medical product.” On top of this, the products have not been adequately tested for safety! This is like driving a car without knowing if the brakes are okay.
Aaron also notes that when they cannot persuade on the merits, tyrants engage in coercion, censorship, mandates, and punishment, which dehumanise people. Sadly, I will need to agree that this is where America, and to a much lesser extent, Europe, is today in relation to vaccines.
This must change radically. We therefore need to support Kennedy as much as we can, as he is the driver of the reforms we need.
