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The U.S. Department of Health and Human Services (HHS) is asking the public to comment on whether the agency should change its vaccine recommendation categories.
The agency is also asking for input on how vaccine recommendations are set and how to rebuild public trust.
Comments are due by Sept. 20, 11:59 ET. The public can submit comments online or mail them to Cynthia Goss, 200 Independence Ave. SW, Washington, D.C., 20201. As of press time today, more than 29,000 comments have been recorded.
In an Aug. 24 notice in the Federal Register, HHS Secretary Robert F. Kennedy Jr. listed 18 questions about vaccine recommendations for the public to answer. People don’t have to answer all 18 questions, Kennedy wrote. Concrete examples are encouraged.
The call for public comments follows President Donald Trump’s Aug. 10 executive order calling for sweeping changes to U.S. vaccine policy, including reducing the number of diseases for which children receive routine vaccines from 18 to 11.
In his order, Trump charged the Task Force on Safer Childhood Vaccines with drafting a report to the White House within 90 days on how to improve vaccine safety and parental vaccine options.
The task force will use the public comments when evaluating whether the agency’s current recommendation framework adequately advances scientific rigor, informed choice and public trust, HHS said in its press release.
An HHS spokesperson told The Defender:
“Under the leadership of President Trump and Secretary Kennedy, HHS is committed to ensuring federal vaccine recommendations are grounded in gold-standard science and transparency to restore trust in our public health institutions.
“The public comment period gives American families, healthcare providers, and other stakeholders a meaningful opportunity to inform the Task Force’s evaluation of the current recommendation framework, and HHS will carefully consider the input received as that work moves forward.”
This is your chance to speak out on vaccine policy — don’t miss out! Take action by Sept. 20: Tell HHS what you think about its updated vaccine policy.
Below are comments submitted to HHS this week by Children’s Health Defense (CHD) scientists Brian Hooker, Ph.D., and Karl Jablonowski, Ph.D.
The Honorable Robert F. Kennedy, Jr.
Secretary, U.S. Department of Health and Human Services
Re: Request for Information: Categories Used in Federal Vaccine Recommendations and the Role of Shared Clinical Decision-Making [Docket No. HHS-OS-2026-0332]
Dear Secretary Kennedy:
This comment responds to the Department’s August 24, 2026 Request for Information (RFI). The RFI asks whether the three recommendation categories—routine, risk-based, and shared clinical decision-making—are adequate, and what considerations should govern category assignment, consent, communication, and public trust. The answers offered here rest on one principle: a Federal recommendation is advice to a free people. It is not a substitute for informed consent, product transparency, or individual clinical judgment.
1. Shared decision-making is the clinical process, not an optional category (Questions 3, 8, and 9)
Question 9 asks whether the term “shared clinical decision-making” creates an unintended contrast with routine recommendations. It does. The label implies that discussion, consent, and individual judgment apply only when the Department withholds a default to vaccinate. That implication is false, and it is harmful.
Shared decision-making is ordinary medicine. It is the conversation in which a clinician presents evidence, uncertainties, alternatives, and risks, and a patient or parent decides. That process belongs to every immunization decision, including those carrying a routine recommendation. The part of medicine that is not subject to shared decision-making is the part in which the patient has no say, the provider is unaccountable, the manufacturer has no liability, and individuality is smothered by the herd. That part of medicine ought not exist.
Question 3 asks whether the current categories unintentionally imply that parental permission and individual consent apply only to the shared-clinical-decision-making category. They do. The framework should say so expressly: the strength of a Federal recommendation is one thing; consent, parental permission, and assent are another. A routine recommendation may state a public-health judgment. It may not convert that judgment into a default, negating the person.
Question 8 asks what shared clinical decision-making should mean in the vaccination context. It should mean a genuine decision, not a scripted assent to a predetermined outcome. An honest practice of it would include disclosure of the provider’s insurance company incentives for immunizations. Even when a clinician decides solely for the patient’s health, revealing potential conflicts of interest is a condition of transparency, not an accusation.
2. Recommendations are not mandates, but they are used as mandates (Question 16)
The RFI states the principle that Federal recommendations are not mandates. Historically and contemporaneously, mandates are how those recommendations are applied—by States, by schools, by employers, and by institutions that treat an ACIP recommendation as a command. Policy that ignores that downstream use is not honest about its own effects.
Explicit language applying shared clinical decision-making to all immunizations would clarify Federal intent when others convert a recommendation into a requirement. If the Department means that a recommendation is advice, the recommendation itself should say that a patient or parent may decline without being treated as noncompliant with Federal policy. Question 16 asks how recommendation policy should account for the effects of compulsion on trust and long-run vaccination behavior. The choice of language can turn a recommended immunization into a compulsory one. Deliberately choose language that cannot be so easily co-opted.
3. Categories should describe evidence and default, not erase the individual (Questions 14–15)
The first word of the Constitution is “We.” Though united, we are individuals. The United States has spent billions of taxpayer dollars on precision medicine because our differences make the difference. We have individual values, preferences, and religious convictions that make the difference to us. This country has never been one-size-fits-all. Public health does not suspend that fact.
Question 14 asks which considerations should predominate. When randomized evidence is strong, disease is severe, and individual benefit is clear, a population-level recommendation may be warranted—still subject to consent. When randomized evidence is limited, absent, infeasible, or unethical to obtain; when benefit varies sharply by person; or when population benefit is gained at the expense of the individual, the presumption should favor individual autonomy, informed consent, and religious freedom.
Question 15 asks how uncertainty should be shown. It should be shown in the recommendation itself: by category, by qualifying language, by a date for re-review, and by an explicit statement of evidentiary certainty. Uncertainty that is resolved silently in favor of a universal recommendation is not science. It is a policy choice disguised as science.
4. A liability shield without product transparency is not a recommendation framework (Question 14)
Product transparency or product liability: at least one must exist. At present we have neither. Liability shields without transparency can conceal generational harms. Those harms can go unacknowledged and uncorrected without society’s corrector, tort. Where product manufacturers enjoy a liability shield, transparency must be absolute.
A workable model is this: remove the barriers that now keep independent researchers from the de-identified Vaccine Safety Datalink, except for an inexpensive human-subjects training certification. Access today requires obstinate institutional-review-board approval from all fourteen participating entities, at an estimated cost of $250,000 per study. Taxpayer-funded data that can reveal some—not all—adverse events following vaccination should be open to any researcher with minimum qualifications. A scientific community with that access will be able to test what “safe” really means in “safe and effective.”
The same standard should apply to the clinical-testing and post-marketing surveillance data on which recommendations for liability-shielded immunizations rest. Question 14 lists evidence quality among the considerations that should govern recommendations. Evidence that cannot be inspected is not evidence of a quality the public is obliged to accept.
5. Trust is a result of integrity, not a communications objective (Question 17)
“Trust” appears twenty-six times in the Request for Information. Question 17 asks what communication practices should accompany vaccine recommendations so that they earn and keep public trust. The premise of the question is only half right. Trust is not a message. It is what remains after institutions tell the truth, including the parts that reduce uptake.
Trust earned by one administration may be abused by another. People “trust” institutions when they feel powerless over those institutions. The health of the United States is not gained by powerlessness. It is gained by citizen authority over their own health, over their own public health, and over the agencies that claim to protect it. An institution accountable to the people need not seek their trust. A Department that wants the long-term health of citizens would not ask for trust. It would lead with integrity and with records the public can read.
The communication practice that follows is therefore not reassurance. It is disclosure: of evidence quality, of uncertainty, of conflicts, of adverse-event data, and of the difference between a recommendation and a mandate. Informed consent without open scientific scrutiny of the underlying information is not consent. Citizens cannot consent to immunization in the absence of information—not even if they wish to. That act would not be called consent. It would be called submission. A medical procedure performed without consent is not a procedure. It is an assault.
6. What the Department should do
Empower the physician and the patient/parent in participatory medicine: “shared clinical decision-making”. Amend the framework so that parental permission, individual consent, and a real clinical conversation apply to every immunization, including those labeled routine.
Write recommendations that cannot be mistaken for mandates. If Federal intent is advice, the text of the recommendation should explicitly state that declination is consistent with Federal policy.
Match category to evidence in public. When evidence is thin or evolving, say so in the recommendation—by category, qualifier, sunset, or certainty grade—rather than defaulting to universal language.
Open the data that a liability shield makes indispensable. Grant minimally qualified researchers inexpensive access to de-identified Vaccine Safety Datalink files, and to the clinical and post-marketing data used to justify shielded products.
Treat trust as a byproduct. Do not ask the public to trust a process it cannot inspect. Make the process inspectable, and let trust follow.
Below are comments submitted to HHS this week by CHD General Counsel Kim Mack Rosenberg:
The Department of Health and Human Services in its August 21, 2026, Request for Information raised issues central to the mission of Children’s Health Defense (“CHD”) and CHD’s Legal Department respectfully submits the following comment.
CHD’s Legal Department is encouraged by the August 10, 2026, Executive Order (the “EO”) entitled “Delivering Gold Standard Childhood Vaccine Recommendations for Americans.” The EO highlights the importance of parental authority, religious freedom, informed consent, and bodily integrity in decision-making regarding childhood vaccination. However, we strongly believe that these rights deserve even more extensive protection. As an initial matter, parents should never be forced to choose between their sincerely held religious beliefs and a child’s access to education.
This is particularly true in the area of vaccinations. Children’s Health Defense’s mission is to restore and protect the health of children by eliminating exposures to environmental toxins, holding responsible parties accountable, and establishing safeguards to prevent future harm to children’s health. Vaccines are at the top of the list of exposures putting children’s health at risk. While parents receive the unsupported marketing message that vaccines are “safe and effective,” vaccine manufacturers are essentially free from liability even when a vaccine injures or kills. Meanwhile, children’s health has precipitously declined as the number of vaccines and doses of vaccines has soared. And with no liability, manufacturers’ profits likewise have skyrocketed. Against this backdrop, protecting constitutional and fundamental rights must take precedence.
Ultimately, we hope that the EO is a first step to cementing legal precedents enshrining the constitutional and fundamental rights of parents to make informed decisions concerning their children’s health. Simply put, parents know their children best and trust in parents’ decision-making capabilities needs to be reestablished. This includes decisions regarding which vaccines their children receive, or whether they receive any at all, regardless of federal recommendations or state or local immunization mandates.
We hope that the U.S. Attorney General, especially given the EO’s directive, takes action against states such as New York, California, Maine, Connecticut, and West Virginia, which deny religious exemptions and parental authority. CHD is participating in a number of cases seeking to restore religious exemptions/accommodations and recognizing the constitutional right of parents to direct their children’s education and healthcare, while respecting informed consent and bodily autonomy. CHD would welcome the Attorney General’s participation in these areas, as recommended by the EO.
Two U.S. Supreme Court decisions issued in the last fifteen months support the work of CHD by recognizing the paramount importance of parental rights: Mahmoud v. Taylor, 606 U.S. 522 (2025), and Mirabelli v. Bonta, 607 U.S. 492 (2026).
While Mahmoud concerned parental rights in the context of curriculum decisions, it was not limited to factual circumstances concerning curriculum decisions; the ruling also contains important pronouncements applicable in the realm of religious exemptions to vaccination. In Mahmoud, the Court clearly stated that when a school policy poses “a very real threat of undermining the religious beliefs and practices that the parents wish to instill in their children” the courts must apply the highest level of scrutiny to those policies, examining whether the state has a compelling justification for the policy and whether the policy is narrowly tailored to serve that interest.[1] The Court specifically found that a policy impeding parents’ ability to opt out of certain curriculum on religious grounds “unconstitutionally burdens the parents’ religious exercise, and [t]he loss of First Amendment freedoms, for even minimal periods of time, unquestionably constitutes irreparable injury.”
Lower courts have attempted to limit Mahmoud to its fact pattern but in the more recent Mirabelli decision the Supreme Court rejected those limitations. In particular, the Court rejected the argument that a California law requiring a school to support or affirm a child’s social transitioning and forbidding the school from alerting parents absent the child’s consent was not governed by Mahmoud because it concerned child safety and public health. Rebuffing that argument, the Supreme Court affirmed that Mahmoud extended beyond curriculum-related policies and protected parental and religious rights from a wide range of school policies. Despite these clear directives, courts, including the Second Circuit, continue to argue that Mahmoud and Mirabelli do not apply in the context of vaccinations. The time is ripe for the Attorney General to follow the EO and step in and step up here.
It also is critical to recognize that the recommendations of the federal government may be persuasive but are not imposed upon states, which establish their own school immunization requirements and schedules (and these do vary from state to state). Thus, we must also acknowledge that even shared decision-making is an imperfect solution, given the censorship surrounding vaccine safety and efficacy. Indeed, many medical professionals receive utterly inadequate training concerning vaccines. Moreover, incentives to medical professionals to maintain a high rate of vaccination in their practices impede unbiased recommendations. These factors, among others, often impede parents’ ability to receive accurate information to exercise true and free informed consent in the vaccination decision-making process.
In sum, while we believe the EO is a good first step and we hope that the Attorney General , vaccinations all should be voluntary and, for children in particular, respect for parental choice must be established for all vaccines.
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CHD Director of Advocacy Michael Kane previously submitted the following comments:
Children’s Health Defense (CHD) Mary Holland previously submitted comments. Children’s Health Defense (CHD) Advocacy Department strongly supports President Trump’s August 10, 2026 Executive Order (EO), “Delivering Gold Standard Childhood Vaccine Recommendations for Americans,” particularly its recognition of the importance of parental authority, informed consent, and religious liberty in decisions regarding childhood vaccination.
The Executive Order specifically directs federal agencies to support maximum parental choice and calls for appropriate legal action concerning state laws that conflict with applicable federal and constitutional protections relating to parental authority and religious freedom, including religious and medical exemptions.
This is especially critical in states where families have been denied religious exemptions from school vaccination requirements, which includes New York, California, Connecticut, Maine and West Virginia.
It is extremely important that the Attorney General’s office follows the guidance put forth in this EO to pursue legal actions against states that deny religious exemptions to vaccination or impede medical exemptions to children who need them. Parents should never be forced to choose between their sincerely held religious beliefs and their children’s access to education.
Parents know their children best. They understand their children’s medical histories, individual health circumstances and unique needs. Healthcare decisions must never be one-size-fits-all. Parents should always have access to clear, complete and understandable information regarding benefits, risks, uncertainties and alternatives for all health interventions to make informed decisions for their children.
We urge the federal government to follow through on all of the EO’s directives and ensure that parental authority, religious liberty, informed consent and the rights of families are strictly protected. Public trust is built through transparency, respect and partnership — not coercion. Parents should be treated as essential partners in their children’s healthcare, not as obstacles to public health.
CHD CEO Mary Holland previously submitted the following comments:
In its Request for Information dated August 21, 2026, the US Department of Health and Human Services asked for “communication practices necessary to earn and maintain public trust.”
To be blunt, HHS must not lie if it is to be able to earn and maintain public trust.
Stating unequivocally that childhood vaccines are “safe and effective” is a lie. They may be safe and effective for some, but are extremely hazardous and ineffective for others. This is why a “one size fits all” vaccination policy has never, and will never, work for all children. Just as some people can take penicillin and be perfectly fine, for others, it is deadly. Vaccine injury has undoubtedly been a driver of the childhood epidemic of chronic disease as substantiated in studies comparing health outcomes in vaccinated and unvaccinated populations.
HHS must treat parents as capable, ultimate decision makers on children’s health. No one knows their children better than they do; no one has more responsibility; no one is in a better position to decide.
We hope that the changes outlined in the August 10 Executive Order become law, that the Attorney General takes action against states that deny religious exemptions to vaccination for children to attend school, and that parents will enjoy maximal choice over childhood vaccines, including the choice to refrain from vaccines altogether.
When HHS acknowledges and respects parental experience and wisdom, operates with transparency and integrity, and refuses to lie, it will have a chance to win back and maintain public trust.
