Is the Extensive US Vaccine Schedule Harmful?

"To me, the study is a strong warning signal and the results are plausible..."

By Peter C. Gotzsche, Brownstone Institute

The US childhood vaccination programme is huge, 68 vaccine doses targeting 18 different diseases versus only 17 vaccine doses for 10 diseases in Denmark.¹

It is unknown if the net effect of so many vaccinations is beneficial, and in August 2025, two physicians launched a federal lawsuit² against the Centers for Disease Control and Prevention (CDC) for failing to study the cumulative effects of its childhood vaccine schedule. They noted that “America administers more vaccines than any nation on earth while producing the sickest children in the developed world.”²

Two researchers who have compared countries found a dose-response relationship: Nations that require more vaccines for their infants had higher infant mortality, neonatal mortality, and under age five mortality.³

Paediatric chronic disease prevalence in the US has risen to nearly 30% in the last 20 years,⁴ and vaccination schedules are among the possible causal factors that Robert F. Kennedy, Jr., Secretary of Health and Human Services, has declared he will investigate. A CDC workgroup will examine if there are any differences in efficacy or safety between the US and Danish schedules.⁵ They will also look at the the timing, order, and ingredients, e.g. the amount of aluminium, which is pertinent, as aluminium in vaccines is harmful.⁶

I am aware of only one study in the whole world that used birth cohorts and compared the occurrence of chronic diseases in a vaccinated group with that in an unvaccinated group and that took account of confounders. It was carried out at the Henry Ford Health System in Detroit but was never published because the researchers were warned that it could cost them their jobs.⁷ The study was completed in 2020, and its results⁸ came to light on 9 September 2025 because it was introduced into the Congressional Record during a Senate hearing on “The Corruption of Science.”⁷

For over two decades,⁵ the Institute of Medicine had urged the CDC to conduct such a study using its Vaccine Safety Datalink, but the CDC never did.

A ground rule in evidence-based medicine is that we should use the best available evidence when we make decisions. 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.

The Henry Ford Study

When I read the unpublished manuscript,⁸ I found that it was above average quality. The authors were genuinely surprised by their results and did sensitivity analyses to test their robustness. They provided a very interesting discussion about issues that might explain their findings, which they put in context. As they had expected to find that vaccination reduces the risk of developing chronic diseases, I see them as being more pro-vaccine than anti-vaccine. For example, they wrote in the Introduction:

“Common parental concerns relate to the growth of the vaccine schedule, administering multiple vaccines contemporaneously, and the potential for long-term adverse health outcomes from vaccination. Research addressing these vaccine safety concerns can assist clinicians in discussions with their patients and serve to reassure parents of the overall safety of vaccination…Addressing this significant data gap could allay parental concerns and bolster vaccine confidence.”

A professor of biostatistics from Pennsylvania, Jeffrey S. Morris, often comments on my tweets about vaccines, and he provided several interesting comments about the study related to my tweets about it. I therefore contacted him and we corresponded about the issues.

Morris and I agree that scientific debate is vital for the progress of science, and I hope that an account of our differing views about the study will be of interest.

The primary outcome of the study was a chronic health composite outcome which included conditions identified by the Child and Adolescent Health Measurement Initiative and augmented with conditions considered to be of public concern or public health significance in the CDC’s White Paper on Studying the Safety of the Childhood Immunization Schedule.

The composite included diabetes, asthma, food allergies, cancer, brain dysfunction, atopic and autoimmune disease, and neurological, neurodevelopmental, seizure, and mental health disorder. Brain dysfunction was defined as encephalopathy or encephalitis. Neurodevelopmental disorders were defined as autism, tics, ADD/ADHD, developmental delay, speech disorder, and learning, motor, intellectual, behavioural, and other psychological disability.

The researchers included 18,468 consecutive subjects, of which 1,957 had not been vaccinated at any time. The major difference at birth was that 37% of the vaccinated kids were Afro-Americans versus 23% of unvaccinated kids. Other differences were rather small, e.g. 6% versus 2% were premature births.

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. The study did not find higher rates of autism, though case numbers were too small to draw a meaningful conclusion.

The authors wrote that, to detect the potential for uncontrolled confounding, the literature suggests having a control condition with no expected causal association with vaccination, and they found no association between vaccine exposure and cancer (182 cases in total).

After 10 years of follow-up, 57% of vaccinated children had developed at least one chronic condition, compared with just 17% of the unvaccinated children. However, as the follow-up was very different, a median of 970 versus 461 days, this estimate is biased.

The researchers acknowledged this confounding factor and also that vaccinated children who see doctors more often than unvaccinated children are more likely to get a diagnosis, and they tried to address this in their analyses (see below).

Morris published a pretty harsh critique of the study.⁹ He noted that the study’s serious design problems kept it from revealing much about whether vaccines affect children’s long-term health, and he quoted a Henry Ford spokesperson for saying to journalists that it “was not published because it did not meet the rigorous scientific standards we demand as a premier medical research institution.”

A more plausible explanation for the censorship is that institutions are horrified by running a risk of being seen as critics of vaccines, which are taboo.¹⁰ If they deviate from the industry mantra that all vaccines are safe and effective, they can expect retaliation.

Morris pointed out that some of the diagnoses “like asthma and ADHD occur after children start school.” He noted that if kids are not followed that long, many cases will be missed, also of learning problems and behavioural issues. He also said that in the sensitivity analyses, using only kids followed beyond age 1, 3 or 5, the vaccinated kids were still tracked longer. This is a valid point, but even after the corrections by the authors, and after excluding kids with no visits, the risk ratios remained much the same.

Morris criticised that the authors “left out” important risk factors: Whether families live in urban, suburban, or rural areas; family income, health insurance, and resources; and environmental exposures such as air and water pollution.

One can always speculate if other confounding factors were unevenly distributed between the two compared groups, but that does not necessarily invalidate a study. Moreover, the researchers did not “leave out” such risk factors. They didn’t have information on socioeconomic status, or other potentially relevant factors, such as diet or lifestyle.⁸

Vaccinated kids had an average of seven visits per year while unvaccinated kids had only two. Morris discussed the potential for detection bias, i.e. the likelihood that getting a diagnosis increases with the number of visits to a doctor, and he noted that leaving out kids with zero visits did not fix the problem because vaccinated kids still had far more visits.

I agree that this is important, but I also observed that Morris avoided discussing biases that went in the opposite direction. The authors wrote that unvaccinated children had an average of almost five annual encounters if diagnosed with a chronic health condition and that this likely demonstrated that when a child had a medical condition, parents sought healthcare. They also noted that many of the conditions they included in their study were serious and cannot be self-treated, such as asthma, diabetes, anaphylaxis, or asthma attacks, warranting urgent medical attention.

If we think doctors do any good, all these extra visits in vaccinated kids should have reduced the occurrence of serious chronic diseases. When I suggested to Morris that the researchers should go back to their data and take account of the criticisms raised, e.g. by excluding all Afro-Americans from both groups, he replied that this was a very small thing that didn’t come close to accounting for the inherent ascertainment issues. But how can he know that? In fact, Morris pointed out the lack of adjusting for socioeconomic factors as a limitation of the study, and I told him that black people are very different from white people, also socioeconomically and that I didn’t agree that such an analysis wouldn’t be important.

Morris forgot a very important bias, the healthy vaccinee bias. It worries me that, despite this bias, those vaccinated became a lot unhealthier than those not vaccinated. Morris tried to talk himself out of this oversight. He said that ascertainment bias was a much more fundamental issue than some vague “vaccinated people are healthier” bias, which he could not know, and added that if someone thinks the bias applies to this setting they should explain exactly how and ideally provide evidence for it or evidence from the literature where it has an effect in similar settings.

At this point, I started to think that maybe, like so many others arguing that a vaccine study that found harms should be distrusted, Morris was not totally objective. I replied that many studies have shown that people who do what their doctors tell them to do have a much better prognosis than those who don’t, and that I wrote about this in my 2013 book about organised crime in the drug industry:¹¹

Patients who do what they are told are generally healthier than others and therefore have better survival even when the drug is placebo. A trial of a lipid-lowering agent, clofibrate, demonstrated this.¹² There was no difference in mortality between drug and placebo, but among those who took more than 80% of the drug, only 15% died, compared to 25% among the rest (P = 0.0001). This doesn’t prove that the drug works of course, and the same difference was seen in the group that received placebo, 15% versus 28% (P = 5 · 10^-16).

Morris opined that unvaccinated kids might have gone elsewhere for routine care and that their diagnoses would therefore not appear in the Henry Ford records. I consider this to be speculation without evidence.

Morris concluded that, because of its shortcomings, the study didn’t show that vaccines cause chronic disease. We may have different views on the merit of a study, but, most importantly, Morris and I could discuss it, in respectful dialogue. I agree entirely with what he recently said in an interview:¹³

During the pandemic, I frequently witnessed people being silenced for asking legitimate questions about matters such as varying Covid risks across different groups, the potential collateral effects of mitigation policies, the immunity from previous infections, and vaccine safety — often because their inquiries were linked to specific political or policy perspectives.

I think we would be in a stronger position regarding public trust if policy makers, the media, and the scientific community had done a better job of listening to those questions, responding objectively with evidence-based answers, openly acknowledging the uncertainties in our knowledge, and the potential limitations of the policies, and most importantly, showing respect for those asking the questions.

At the Senate hearing, the fiercest attack came from Dr Jake Scott, an infectious-disease physician at Stanford, who dismissed the Henry Ford study as “flawed by design.”⁷ He said it was “statistically impossible” that nearly 2,000 unvaccinated children could have zero ADHD cases. But is it? The birth cohort was not followed for very long, and it is very rare to diagnose ADHD in very young children, so this is not statistically impossible.

My conclusion is that it would be wrong to dismiss the only, and therefore also the best, study we have. To me, the study is a strong warning signal and the results are plausible. The researchers wrote that childhood infections appear to provide significant protection from atopy and that it has been suggested that vaccination can contribute to atopy.

We need to find out if there are other such studies that remain unpublished for fear of retaliation and to develop methods to find them as part of a systematic effort.

The data the researchers collected are very valuable and they should give other researchers access to them, so that we may all learn more through additional analyses. This can be done in a pseudonymised fashion on a secure platform. The researchers have a moral obligation to do this for the common good, and if they resist, I hope Kennedy will force them to do it.

References

1. Demasi M. Too many vaccines on the childhood immunisation schedule? Substack 2024;Dec 16.

2. Lawsuit against the Centers for Disease Control and Prevention. United States District Court, District of Columbia 2025;Aug 15.

3. Goldman GS, Miller NZ. Reaffirming a Positive Correlation Between Number of Vaccine Doses and Infant Mortality Rates: A Response to Critics. Cureus 2023;15:e34566.

4. Rivero E. Pediatric chronic disease prevalence has risen to nearly 30% in the last 20 years. UCLA Health 2025;March 10.

5. Demasi M. CDC advisors launch workgroup to probe childhood vaccine schedule. Substack 2025;Oct 20.

6. Gøtzsche PC. Aluminium in Vaccines Is Harmful. Brownstone Journal 2025;Oct 6.

7. Demasi M. Inside the Henry Ford vaccine controversy. Substack 2025;Oct 15.

8. Lamerato L, Chatfield A, Tang A, Zervos M. Unpublished manuscript. Impact of Childhood Vaccination on Short and Long-Term Chronic Health Outcomes in Children: A Birth Cohort Study. Henry Ford Health System, Detroit MI.

9. Morris JF. Why a study claiming vaccines cause chronic illness is severely flawed – a biostatistician explains the biases and unsupported conclusions. The Conversation 2025;Sept 26.

10. Gøtzsche PC. The Chinese virus: Killed millions and scientific freedom. Copenhagen: Institute for Scientific Freedom; 2022 (freely available).

11. Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publishing; 2013.

12. The Coronary Drug Project Research Group. Influence of adherence to treatment and response of cholesterol on mortality in the coronary drug project. N Engl J Med 1980;303:1038–41.

13. Talpos S. Interview: How to Discuss Vaccines Amid the Partisan Divide. Undark 2025;Sept 1.

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