Comments on US vaccine policy invited by the Department of Health and Human Services

By Peter C Gøtzsche, Professor emeritus, Institute for Scientific Freedom, Copenhagen

On 24 August, the Department of Health and Human Services (HHS) issued a call for comments on categories used in federal vaccine recommendations and the role of shared clinical decision-making.¹

Two weeks earlier, the President signed the Executive Order “Delivering gold standard childhood vaccine recommendations for Americans.”² It states that the policy of the United States is that core childhood vaccine recommendations should be aligned with scientific evidence and best practices of peer nations and that federal programs should support parental choice consistent with personal autonomy and informed consent.

These are much-needed initiatives considering that the fundamental ethical principle of informed consent, which is a prima fascie duty to respect, was violated during the Covid-19 pandemic. It is not surprising that public trust in federal public health agencies declined measurably during and after the pandemic.

UNESCO’s Universal Declaration on Bioethics and Human Rights states that “Any preventive, diagnostic and therapeutic medical intervention is only to be carried out with the prior, free and informed consent of the person concerned, based on adequate information. The consent should, where appropriate, be express and may be withdrawn by the person concerned at any time and for any reason without disadvantage or prejudice.”³

Accordingly, vaccines cannot be forced upon people, directly or indirectly, through deprivation of privileges the individual would otherwise have had (e.g., the right to go to school, to have a job, or to earn a living), all of which can be equated with coercion.⁴

The categories

There are three categories:

1. A routine (universal) recommendation is to vaccinate all persons in an age group absent contraindications.

2. A risk-based recommendation is directed to persons with specified medical, occupational, behavioral, or other risk factors.

3. Shared clinical decision-making (SCDM), also referred to as individual-based decision-making, is individually based and informed by a decision process between the health care provider and the patient or parent/guardian.

CDC guidance explains that for routine, catch-up, and risk-based recommendations “the default decision should be to vaccinate,” whereas for SCDM recommendations “there is no default”; the decision turns on the individual’s characteristics, the best available scientific evidence, the clinical discretion of the provider, and the values and preferences of the patient or parent.

CDC’s Advisory Committee on Immunization Practices (ACIP) adopted the SCDM terminology in 2019, replacing the earlier “Category A”/“Category B” (permissive) framework. It applies the category through an Evidence to Recommendations (EtR) framework, adopted in 2018, that contemplates three outcomes:

- a recommendation for all persons in an age or risk group;

- a recommendation for individuals based on shared clinical decision-making;

- no recommendation.

In Category A, the vaccine was recommended for routine universal use in a targeted population, whereas in Category B, the vaccine was recommended for use in individual patients based on the medical judgment of the medical provider.⁵

The HHS asks if the current categories unintentionally imply that parental permission, individual consent, or meaningful clinical discussion applies only to shared clinical decision-making recommendations? And if the current category structure adequately serves the goals of scientific rigor, informed choice, and public trust.

I believe the current categories are confusing. They imply that informed consent is only needed for category 3 recommendations, but it is essential for all medical decisions. It is therefore misleading to use the term “shared clinical decision-making” for category 3 only.

Moreover, a category is missing, one about recommending against a vaccine. That a drug has been approved by the FDA does not necessarily mean that its use should be recommended.

I am a Danish specialist in internal medicine and have worked for over three years at a department of infectious and tropical diseases. In my view, the new categories are not less confusing than the old A and B ones. I suggest these categories, which are easier to understand:

1. Recommended. All persons in an age group should be vaccinated absent contraindications or special circumstances.

2. No general recommendation for or against vaccination.

3. Not recommended, or only in exceptional circumstances.

The HHS asks if “shared clinical decision-making” and “individual-based decision-making” differ? They don’t. The two concepts are the same. We always need to consider individual circumstances and to respect informed consent. Moreover, evidence-based medicine is the integration of the best available scientific evidence with clinical expertise and the individual patient’s values, preferences, and unique circumstances.⁶

I agree with the HHS that, as shared decision-making describes a clinical process applicable to all vaccine decisions, it creates an unintended contrast with routine recommendations.

Basic ethical principles and the issue of vaccine mandates

Basic principles in medical ethics are routinely being ignored and violated in vaccine recommendations. So-called experts in public health generally know very little about medical ethics and tend to be highly paternalistic, telling people what to do rather than providing honest information that allows them to decide for themselves.

To do much better in future, it is of utmost importance to understand this. I have a whole chapter in my vaccine book where I outline the principles for ethical argumentation and explain why vaccine mandates are unethical.⁴

There are three forms of paternalism:

- Genuine paternalism, where, for example, parents care for their children, or doctors do their best to help comatose people survive;

- Solicited paternalism, where, for example, the patient facing different choices asks the doctor to decide; and

- Unsolicited paternalism, where the patient did not give permission for others to intervene.

We do not accept unsolicited paternalism in healthcare, but vaccine policies have been a curious exception and when vaccines are mandated “for our own sake,” it is a gross violation of autonomy.

Public health “experts” invariably focus on utilitarian ethics, the greatest good for the greatest number of people, and forget about deontology, which is a key principle in medical ethics about our duties, irrespective of the consequences, which usually override any utilitarian considerations. They include:

- The Hippocratic principle: First, do no harm.

- Respect for autonomy.

- That fully informed consent should always be ensured.

Based on utilitarian reasoning, it can be argued that a person could be thrown overboard from a sinking boat if this helps the remaining people survive, but it is indefensible from a deontological perspective.

Vaccine mandates to protect others, e.g. for healthcare workers during the pandemic, are unethical. We cannot demand that people run a personal risk to protect others. It violates their autonomy, and, in rare cases, vaccines kill people or harm them seriously.^4,7,8

When discussing vaccine policies, we need to get the facts right, which can be difficult, particularly considering the almost universal absence of placebo-controlled trials,^9,10 and that data on mortality and other serious consequences of infections or of getting vaccinated are usually lacking.⁴

On the first page in my vaccine book,⁴ I mention what the key issues are:

What is the risk of getting infected and of getting seriously harmed or killed because of the infection? How are these risks changed with a vaccine, and what is the risk of getting seriously harmed or killed because of the vaccination?

When people decide on vaccine policies, they virtually always overlook that, even when we agree on the facts, we cannot derive an “ought” from an “is,” as the “ought” involves an ethical choice. We cannot derive “we must” from “we can.”

Another principle that is also very often ignored is that there needs to be consistency. If two cases are treated differently, we must be able to demonstrate an ethically relevant difference between them. The same principle applies in common law.

The President stated that core childhood vaccine recommendations should be aligned with scientific evidence and best practices of peer nations,² and Health Secretary Robert F. Kennedy, Jr., wants the US program to resemble the much less extensive one we have in Denmark.¹¹ Unfortunately, Kennedy’s very reasonable vaccine initiatives have consistently been denigrated in the US media^12,13 and even one of our most respected medical journals, the BMJ, had nothing to offer but attempts at character assassination.¹⁴

It is no wonder that some people speak about health fascism when the do-gooders seem to have no limits in their public attacks on the reformers and violate basic human rights when they make vaccination mandatory.

I shall not discuss the science related to the US experience with vaccine mandates, but it seems to me that the consequences have been the opposite of what was intended. The mandates have likely increased vaccine hesitancy in general, which is an important reason why most European countries are against mandates.

The HHS report mentions that global guidance on mandatory vaccination counsels that policymakers “have a duty to carefully consider the effect that mandating vaccination could have on public confidence and public trust,” and that mandates are not ethically justified where public health goals can be achieved through less coercive means.¹

These are utilitarian arguments and they are irrelevant because we must respect informed consent at all times, whatever public health ”experts” might think about the consequences. If we felt that the goal justifies the means, we would ban tobacco and junk food, which would save many more lives than mandating vaccines could ever do.

In my country, Denmark, we have no vaccine mandates. We had one for the smallpox vaccine, from 1810 to 1976, which is estimated to have saved hundreds of millions of lives.¹⁵ For most Europeans, the US mandates are absurd, and I shall give some examples.

The Covid-19 vaccines were mandated and presidential advisor Anthony Fauci claimed that they can prevent transmission.^16,17 However, this has never been documented and is not even likely because the vaccines produce IgG antibodies in the blood, whereas the production of IgA in the nasal mucosa is not affected. And the public has experienced that the virus can easily spread in a fully vaccinated population and that they can get infected despite being fully vaccinated.

Fauci was not alone in causing people’s lack of trust. Both he, President Joe Biden, the FDA, the Australian government, Science Magazine, Reuters, CNN, US National Public Radio, The Hill, Sky News, Pfizer, Moderna, AstraZeneca, and Johnson & Johnson claimed 100% efficacy of the Covid-19 vaccines.¹⁸ However, the efficacy of the vaccines against infection is so poor that the CDC reported a rate as low as 24% after two vaccine doses.¹⁹

Fauci’s newly released diary and emails demonstrate that he systematically deceived the public during the pandemic, which had a devastating influence on Covid policies in the whole world and for people’s trust in official advice. He lied about virtually everything:^17,20 The origin of the virus, his NIH funding that created the monster that killed an estimated 26 million people if we add the casualties caused by the lockdowns,²¹ and his own role in the lockdowns and in mandating face masks and vaccination.

In contrast to Fauci and his allies, Sweden respected the science.²² Face masks were not mandated, and it was very rare to see a Swede wearing one. Sweden largely avoided lockdowns and had the lowest excess mortality in the whole western world during the pandemic^21,22 (excess mortality is the increase in all-cause mortality during the pandemic compared with prepandemic levels).

It is unfortunate that US states do not have the same vaccine policies. In California, a school or other institution could require documentary proof of vaccination against any disease deemed appropriate.⁴

A lawyer successfully struck down as illegal the New York City Department of Health’s flu shot requirement for preschoolers, but even though the requirement was unjustified, both ethically and scientifically, the victory was overturned by the highest court.⁴

In 2017, a senior faculty member at the New York University School of Medicine, who did not even do clinical work, had her faculty appointment terminated because she did not get a flu shot.²³ This was not an act of unsolicited paternalism; it looked more like a crime to me. Flu shots cannot protect against transmission because they do not produce IgA antibodies in the nasal mucosa.

HPV vaccination for school attendance is required in District of Columbia, Hawaii, Rhode Island, and Virginia.²⁴ This is insane. HPV does hopefully not spread in the classroom. The drug regulators and the drug companies have denied that the vaccines can cause serious, long-lasting neurological harms, e.g. POTS (Postural Orthostatic Tachycardia Syndrome), but in my capacity as an expert witness in a court trial against Merck, I uncovered numerous counts of fraud where Merck had hidden these harms, both for the public and the FDA, against the law, which another expert witness also found.⁸ Since cervical cancer can be avoided by going to screening and since some people are not at risk of contracting HPV infection, e.g. because they don’t have sex or only have sex with their partner, it can be argued that the HPV vaccines should not be a category 1 recommendation.

What should we do if parents refuse to have their children vaccinated? Here, the consistency principle is helpful. In Denmark, an adult can refuse a life-saving blood transfusion. A woman belonging to the Jehovah’s Witnesses sect refused blood transfusions after childbirth, even though she bled profusely and was told she would very likely die without the transfusions.⁴ She died. As she knew the consequences of her choice, transfusions were not allowed, not even when she had become unconscious. This may seem cruel, but her wish was respected.

But if a child of a Jehovah’s Witness is brought in after a traffic accident and the parents refuse life-saving transfusions, the state is obliged to protect the vulnerable minor, just like in any other case of child neglect, and the child will get the transfusions.

We cannot compare this directly with parents who refuse to have their child vaccinated against measles because the child is not in immediate danger. But if it could be considered child neglect, e.g. if a severe measles epidemic was coming, the state might intervene.

The way forward: honest information to the public and lack of censorship

It is a prima facie ethical duty that healthcare authorities must always communicate honestly what they know and don’t know about healthcare interventions, whatever the consequences are, and with no censorship.

In 2023, Kennedy, the current health secretary, said that “When people censor speech, when we look back in history, they’re never the good guys. Government abuses every power that it’s given, and if government suddenly has the capacity to censor its critics, it has a license for any atrocity ... We can’t have a democracy if we don’t have freedom of speech.”²⁵

Unfortunately, many public health “experts” and people at the top in healthcare institutions and in the government believe they are entitled to censor information for the public even when this information is important for people. I consider this unbelievably arrogant and an abuse of power. And when the public finds out that the experts have lied to them,^17,18,20 they lose confidence in science and in public health advice, which is harmful because it increases vaccine hesitancy even for highly beneficial vaccines like the measles vaccines.

There is a lot we don’t know about vaccines. For none of the vaccines in the US childhood program have there been any placebo-controlled trial that played any role for the FDA approval of the vaccines.^9,10 We therefore don’t know what the harms are, or if the benefits outweigh the harms for all the vaccines in any type of child. This is not the case for the Covid-19 vaccines,⁷ which were nonetheless recommended for children in the US down to 6 months of age till recently.

An important but overlooked issue in vaccine recommendations is the nonspecific effects of vaccines. The groundbreaking research by Danish vaccine researchers Peter Aaby and Christine Stabell Benn is so famous that it is on the list of vaccine milestones in Nature that starts with the discovery of the smallpox vaccine.²⁶

Aaby and Benn have shown in randomized trials and carefully controlled observational studies that live, attenuated vaccines like the measles vaccine reduce overall mortality more than can be predicted from their specific effect, while non-live vaccines increase overall mortality; that the order of vaccination is important; that it is best to finish with a live vaccine; and that the harmful effects of non-live vaccines predominantly affect girls.²⁷

It is of utmost importance to heed these findings in vaccine recommendations and to do randomized trials powered to detect effects on total mortality.

The DTP vaccine and the deplorable role of the WHO and Cochrane

It seems obvious that people in the whole world should get the trivalent diphtheria, tetanus, and pertussis (DTP) vaccine because these diseases are horrible and kill people. But it is not that simple, which I wrote an expert report about.²⁸

Aaby found that the DTP vaccine increased overall mortality in Guinea-Bissau and other low-income countries. This didn’t make him popular at the WHO headquarters, and the WHO published a report in 2014 in response to his findings.²⁹

I updated WHO’s literature searches and found two additional, highly relevant studies where Aaby showed that the DTP vaccine doubled mortality. There were major problems with the WHO report.²⁸ One was that the authors did not provide summary estimates because WHO’s working group had requested that meta-analyses not be done. This is an unacceptable interference with research by a group that includes people with numerous financial conflicts of interest in relation to vaccines. It is difficult to understand why this demand - which I have not seen elsewhere - was introduced unless the WHO didn’t want to run a risk of confirming that the DTP vaccine increases mortality.

Aaby has pointed out that the WHO uses the DTP vaccine as a marker for good coverage of vaccination in general. This should not happen. Program performance indicators should be those that are known to be positively associated with increased survival.

The WHO has not changed anything, and the authors, who were from Cochrane, sacrificed several sound scientific principles to help the WHO get off the hook.²⁸

Aaby’s findings are far more convincing than those in the WHO report. Interestingly, the Cochrane people later published their research in the BMJ, and this time, being freed from the WHO censorship, they provided meta-analysis estimates and reported that the DTP vaccine was associated with a possible increase in all-cause mortality, risk ratio risk 1.38 (0.92 to 2.08) and that the effect seemed stronger in girls than in boys.³⁰

I do not suggest that we should not recommend people to get the DTP vaccine in the United States and other high-income countries, but Aaby’s findings and the WHO’s turning a blind eye to them are troubling, and more research is needed.

Considerations in setting recommendations

The HHS asks what considerations should be relied upon in establishing vaccine recommendations and assigning categories, and under what conditions each should predominate, considering the availability, quality, and strength of evidence; the appropriate approach where randomized controlled trial evidence is absent, infeasible, or unethical to obtain; disease severity and epidemiology; individual versus population benefit; and if uncertainty should be reflected in the recommendation itself, rather than resolved silently in favor of either a universal recommendation or no recommendation.

Transparency and honesty are everything and should be reflected in the recommendations. Public health “experts” tend to think that if only some lives can be saved, there is nothing to discuss. This is very wrong.

Firstly, we rarely know if any lives can be saved and such claims often come from unreliable case-control studies that suffer from insurmountable biases, of which one is the healthy volunteer bias: Those who get vaccinated are generally healthier than others.⁴ Information about vaccine efficacy must always be accompanied by information about the type of study it is derived from, with caveats if it is not randomized trials. The old CDC hyped flu shots to the extreme while failing to inform the public that the extremely implausible estimates of lives saved were based on case-control studies.⁴ This must never happen again.

Secondly, in the very rare cases where we have reliable evidence that a vaccine can save lives, it is virtually always related to the microorganism vaccinated against, but non-live vaccines tend to increase total mortality.

Thirdly, public health is not individual health. The citizen may ask: What’s in it for me? Vaccines are special because very many people need to be vaccinated for one to benefit (number needed to treat, which varies with the prevalence of the disease and the individual risk of getting infected). If the number needed to harm is smaller than this, it might not be worthwhile to take the vaccine. Unfortunately, it is very rare to see any such estimates.

Given the uncertainties and the possibility of harm, I find that some vaccines should not be universally recommended. I have already mentioned the HPV vaccines, and here are additional examples.

Covid-19 annual boosters have been recommended in the US but the European Medicines Agency (EMA) was concerned that they might overload people’s immune system.³¹ There were also warnings from scientists, including senior FDA vaccine officials, that the evidence did not support boosters for the general population.¹ However, when ACIP in September 2021 voted against recommending boosters doses for adults aged 18 to 64 on the basis of occupational or institutional exposure, the CDC director set that vote aside.¹ Such moves are very harmful for public trust.

Having acquired natural immunity to Covid-19 should have led to a recommendation that vaccination could be skipped but the US policy mandated vaccination even for such people.

The CDC has admitted that repeated influenza vaccination can weaken the immune response to subsequent influenza vaccination,³² and Canadian observational studies showed that people receiving a seasonal influenza vaccine have an increased risk of getting infected with another strain in the next season.³³ Other researchers reported that annual influenza vaccination hampers development of CD8 T-cell immunity in children.³⁴

Given this knowledge, and the poor effect flu shots have,³⁵ it seems unwarranted to advise people to get a flu shot every year in their entire life, from 6 months of age, which the CDC recommends.³⁶ This is a gigantic, uncontrolled experiment with human beings, and people giving such advice seem to ignore the potential vaccine harms. The Pandemrix influenza vaccine caused narcolepsy, a serious irreversible condition for which there is no cure, in people with certain tissue types.⁴ In Denmark, annual flu shots are not recommended for everyone, and only one fifth of people aged 0 to 64 years at particular risk got a flu shot in 2024.³⁷ Many doctors who know a good deal about flu shots, never get vaccinated, also because the risk of getting influenza is very low.

When I wrote my vaccine book,⁴ I used the vaccine against Japanese encephalitis as an example of a vaccine that should be recommended against, my suggested category 3. I used concrete numbers to demonstrate that travelers to endemic areas, where they can get the disease from mosquitoes and die from it, should not get vaccinated if they are just on a short-term vacation. One of the reasons is that the vaccine can be deadly.

The CDC tells you to “Talk to your doctor,” but in an area with so much uncertainty, and with such a rare disease far from home, it is unlikely a doctor would be a qualified advisor. It is more a matter of the authorities avoiding any responsibility by passing the buck. If the vaccine kills a person, which it might, they can say that they did warn you. We need more honest information than this.

References

1 Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making. Health and Human Services Department 2026;Aug 24.

2 Executive Order No. 14,420. Delivering gold standard childhood vaccine recommendations for Americans. The White House 2026;Aug 14.

3 Universal Declaration on Bioethics and Human Rights. UNESCO 2005;Oct 19.

4 Gøtzsche PC. Vaccines: truth, lies, and controversy. New York: Skyhorse; 2021.

5 Tan L. Adult vaccination: Now is the time to realize an unfulfilled potential. Hum Vaccin Immunother 2015;11:2158-66.

6 Straus S, Haynes B, Glasziou P, Dickersin K, Guyatt G. Misunderstandings, misperceptions, and mistakes. ACP J Club 2007;146:A8-9.

7 Gøtzsche PC, Demasi M. Serious harms of the COVID-19 vaccines: a systematic review. Institute for Scientific Freedom 2023;March 22.

8 Gøtzsche PC. How Merck and drug regulators hid serious harms of the HPV vaccines. New York: Skyhorse; 2025.

9 Gøtzsche PC. A masterpiece: Lawyer Aaron Siri’s book “Vaccines, Amen: The Religion of Vaccines”. “If you want the real truth about drugs, don’t ask doctors – ask lawyers.” Gøtzsche’s Perspective 2026;Jan 22.

10 Siri A. Vaccines, Amen. The religion of vaccines. Injecting Freedom; 2025.

11 Lovelace B Jr., Edwards E, Fattah M, Bendix A. RFK Jr. overhauls childhood vaccine schedule to resemble Denmark’s in unprecedented move. NBC 2026;Jan5.

12 Gøtzsche PC. Reduced US childhood vaccination schedule was denigrated in the media. Gøtzsche’s Perspective 2026;Jan 16.

13 Gøtzsche PC. Hepatitis B Vaccination of Newborns: Seriously Misleading Media Reports. Brownstone Journal 2025;Dec 19.

14 Gøtzsche PC. BMJ’s Coverage of Kennedy’s Vaccine Reforms Amounts to Character Assassination. J Acad Publ Health 2025;Nov 10.

15 Ochmann S, Roser M. Smallpox: disease, transmission & symptoms. Our World in Data 2019.

16 Choi J. Fauci: Vaccinated people become ‘dead ends’ for the coronavirus. The Hill 2021;May 16.

17 Gøtzsche PC. Fauci’s lies about Covid-19 illustrate the institutional corruption in healthcare. Gøtzsche’s Perspective 2026;Aug 24.

18 Gøtzsche PC. The Chinese virus: Killed millions and scientific freedom. Copenhagen: Institute for Scientific Freedom; 2022. Freely available book.

19 New COVID-19 vaccine effectiveness data showcase protection gained by 3rd and 4th doses. CDC 2022;July 15.

20 Gøtzsche PC. The Fauci papers reveal his narcissism and devastating lies about Covid-19. Gøtzsche’s Perspective 2026;Sep 1.

21 Gøtzsche PC. Did the Draconian Lockdowns Kill More People than Covid-19? Brownstone Journal 2025;Dec 2.

22 Gøtzsche PC. Sweden did exceptionally well during the COVID-19 pandemic with its open society. Brownstone Journal 2023;March 28.

23 McCartney M. New York University sacks professor for refusing flu shot. BMJ 2017;357:j1975.

24 HPV (Human Papillomavirus) vaccine requirements for secondary school. Immunize.org 2026;May.

25 Penley T. RFK Jr. warns government censorship could open door to ‘atrocity’ days after face-off with House Democrats. Kennedy warned that democracy will ‘wither and die’ without free speech. Fox News 2023;July 23.

26 Flemming A. Nature milestones in vaccines. Nature 2020;Sept 28.

27 Benn CS, Fisker AB, Aaby P (eds.). Bandim Health Project 1978 – 2018: forty years of contradicting conventional wisdom. 2018.

28 Gøtzsche PC. Effect of DTP vaccines on mortality in children in low-income countries. Expert Report 2019;June 19.

29 Higgins JPT, Soares-Weiser K, Reingold A. Systematic review of the non-specific effects of BCG, DTP and measles containing vaccines. WHO 2014;March 13.

30 Higgins JP, Soares-Weiser K, López-López JA, et al. Association of BCG, DTP, and measles containing vaccines with childhood mortality: systematic review. BMJ 2016;355:i5170.

31 EMA regular press briefing on COVID-19. EMA 2022;Jan 18. The statement is on YouTube:

32 Vaccine effectiveness: How well do the flu vaccines work? CDC 2018;Oct 12.

33 Skowronski DM, De Serres G, Crowcroft NS, et al. Association between the 2008–09 seasonal influenza vaccine and pandemic H1N1 illness during spring–summer 2009: four observational studies from Canada. PLoS Med 2010;7:e1000258.

34 Doshi P. Influenza vaccines: Time for a rethink. JAMA Intern Med 2013;173:1014-6.

35 Demicheli V, Jefferson T, Ferroni E, Rivetti A, Di Pietrantonj C. Vaccines for preventing influenza in healthy adults. Cochrane Database Syst Rev 2018;2:CD001269.

36 Who needs a flu vaccine. CDC 2025;Sept 18.

37 Afsluttende status: Sæsonvaccination mod covid-19 og influenza i 2024. Sundhedsstyrelsen 2025;Jan 7.