Although adult and childhood vaccine recommendations have changed under a Centers for Disease Control and Prevention (CDC) shift, the overall legal framework regarding informed consent and protections for vaccine administrators has not, according to various legal and medical analyses.
Nor has the science, Texas Medical Association leaders say, as reinforced by a recent TMA Board of Trustees interim action.
Updates to CDC’s vaccination schedule as of Jan. 5 show a decrease in child immunizations, reducing the number of targeted diseases from 17 to 11. The number of adult vaccines was also reduced from 13 to seven, downgrading immunizations for illnesses like influenza and COVID-19.
Rotavirus, COVID-19, influenza, hepatitis A, hepatitis B, and meningococcal vaccines are no longer recommended as routine by the Advisory Committee on Immunization Practices (ACIP) and now fall under shared clinical decision making (SCDM). ACIP describes the SCDM process as individually based between a health provider and the patient or parent/guardians. For other diseases, the CDC recommends immunization for named high-risk groups and populations.
These changes, along with accompanying statements from Robert F. Kennedy, Jr., secretary of the U.S. Department of Health and Human Services, as well as those from CDC, have raised questions about increased liability risks for administering vaccines.
In August of 2025, Secretary Kennedy tweeted that “[vaccine] recommendations that diverge from the CDC’s official list are not shielded from liability under the 1986 Vaccine Injury Act.” In the press releases announcing the change to SCDM for the COVID-19 and hepatitis B vaccines, CDC characterized the changes as promoting informed consent.
According to various medical publications, the liability framework hasn’t changed around informed consent and the Vaccine Injury Compensation Program (VICP), established by the Vaccine Injury Act.
In the rare instance where an injury results from a covered vaccination, the VICP provides an initial alternative to civil litigation against a vaccine manufacturer or administrator, with an administrative process and government fund for compensating injured persons.
However, whether a vaccine is subject to the VICP is not tied to the CDC’s vaccination recommendations. Rather, VICP inclusion depends on whether the vaccine is listed in the Vaccine Injury Table, which is located in federal rules. As indicated in Think Global Health by Dorit Reiss, a law professor at the University of California, San Francisco, removing a vaccine from the table through normal legal processes would require federal rulemaking.
Of the seven vaccines with changed recommendations, six are still listed on the Vaccine Injury Table (Rotavirus, influenza, hepatitis A, hepatitis B, and meningococcal). Though the COVID-19 vaccine is not listed there, vaccine manufacturers and administrators fall within the liability protections of the PREP Act for COVID-19 Countermeasures, which have been extended to Dec. 31, 2029.
Rochelle Walensky, MD, former head of CDC, co-authored a piece in the Journal of the American Medical Association (JAMA) that acknowledges how recent changes “have sowed confusion, fear and uncertainty among physicians and the public.”
“However, changes to the vaccines recommended by ACIP and CDC need not, and should not, substantially affect clinical practice,” the article notes.
Dr. Walensky and her co-authors said there could be changes to the restrictions on payment by Medicare, Medicaid, and the Vaccines for Children program, “although that appears stable for now.”
“Going forward, clinicians should stay abreast of payment changes but feel confident in continuing to recommend and administer vaccines in accordance with unswerving professional consensus,” the JAMA paper concluded.
A summary from the Association of Immunization Managers similarly states, “There is agreement among some legal scholars that clinicians are at no greater risk of successful litigation now than they were before Jan. 5, 2026.” The post notes, though, that “baseless suits and complaints to licensing boards could still be brought, and those can be stressful and expensive, even if not ultimately successful.”
CDC’s change to SCDM for certain vaccines has also raised the question of whether informed consent discussion are affected.
For many vaccines, there is a federal requirement to provide a Vaccine Information Statement (VIS) or a fact sheet to recipients. This includes vaccines that are covered under the National Vaccine Childhood Injury Act.
As CDC explains, “VISs are written to fulfill the information requirements of the National Childhood Vaccine Injury Act, not as informed consent forms. But because they cover both benefits and risks associated with vaccinations, they provide enough information that anyone reading them should be adequately informed.”
TMA analysts point out that Texas law already has a framework in place describing what information needs to be disclosed to the patient to obtain informed consent. The Texas Medical Disclosure Panel (TMDP) maintains a list of certain procedures that require specific disclosures and consent in writing, as well as other procedures that do not require any specific disclosures. For procedures not on either list – such as vaccinations – a physician must disclose the risks and hazards that could influence a reasonable person’s decision to consent.
A CDC FAQ about SCDM describes it as “informed by the best available evidence of who may benefit from vaccination; the individual’s characteristics, values, and preferences; the health care provider’s clinical discretion; and the characteristics of the vaccine being considered.”
As of this writing, CDC has not provided SCDM guidance for each vaccine for which it is now recommended. However, in the notes for the child/adolescent and adult immunization schedules, the CDC has published SCDM information specific to certain vaccines. These suggest that SCDM considerations for a vaccine may depend on the patient’s demographics and individual characteristics.
For example, the adult 27-45 HPV vaccine SCDM document notes the vaccination is not indicated for most adults in this age group and that the vaccine’s effectiveness may depend on the patient’s number of previous sexual partners. Similarly, the meningococcal B SCDM for persons 16-23 years of age notes that the vaccine is not routinely recommended for all people in this age group and that the disease most commonly affects young adults who attend a four-year university, are freshmen, live in on-campus housing, or participate in sororities or fraternities.
Texas’s informed consent statute addresses disclosure of the “risks and hazards” of a procedure. As no court has addressed this statute in the context of CDC’s new SCDM recommendations, it is uncertain whether a plaintiff could successfully argue that informed consent also includes an individual’s SCDM considerations.
As noted by the Association of Immunization Managers, there is also the potential of complaints to licensing boards. Under the Texas Medical Board’s disciplinary guidelines, in addition to discipline for failure to obtain informed consent, physicians may be sanctioned for “failure to disclose reasonable alternative treatments to a proposed procedure or treatment.”
As such, for vaccines that are now recommended for SCDM, practices may consider reducing potential legal risks by discussing and documenting the individual criteria that could be relevant to the individual patient’s decision to consent to the vaccination.
In addition, as of Sept. 1, Texas added another layer to the informed consent process for COVID-19 vaccines. House Bill 4535, which passed in the 2025 legislative session, mandates physicians obtain written informed consent accompanied by an information sheet specific to COVID-19 vaccines, developed by the Texas Department of State Health Services (DSHS). The COVID-19 vaccine information sheet is available on DSHS’ immunization resources page under vaccine information statements.
“The science hasn’t changed,” said Lauren Gambill, MD, a former chair and current member of TMA’s Committee on Child and Adolescent Health. The Austin pediatrician says physicians have always supported families making the best decisions for them.
“No family is bringing their kid to the pediatrician and not wanting to do the best thing for their kid,” Dr. Gambill said. “There’s just so much misinformation out there and so much confusion, information from so many different sources, it can be really difficult to figure out what that best thing is.”
NOTICE: This publication, the Texas Medical Association’s (TMA)’s interim policy, and any reference made by TMA to any entity’s immunization schedules, vaccination recommendations and resources (hereinafter “the Vaccine-related Information”) are intended for general informational purposes only.
The Vaccine-related Information does not constitute medical advice or legal advice and does not ensure a successful outcome. The Vaccine-related Information does not substitute for the advice of an attorney or a physician’s own professional judgment or the judgment of other clinicians in the physician’s practice.
Physicians should consult with their own privately retained attorney for specific legal advice related to vaccines. Physicians should consult with their own professional liability carrier for risk management information and to discuss their liability coverage and any exclusions under their liability policies (e.g., to determine if COVID-19 vaccine protections are included or excluded). Administering or prescribing a vaccine to an individual outside of the current FDA label would be considered “off label” use. Physicians should consult their own liability insurance to see if “off label” prescribing is covered for each vaccine to be prescribed or administered.
Physicians should also check with their health insurance company/third-party payors regarding their vaccine coverage policies, including for off-label use. Coverage and reimbursement may vary based upon payor.
The Vaccine-related Information is not intended to establish medical standards of care for the purposes of litigation, including expert testimony. The standard of care is dependent upon the particular facts and circumstances of each individual case and no generalization can be made that would apply to all cases
Reference to the Vaccine-related Information of a particular entity does not constitute an express or implied endorsement of the referenced entity or the referenced entity’s Vaccine-related information. TMA does not guarantee that any referenced entity’s Vaccine-related information is based on peer-reviewed, scientific evidence, and subject to independent expert review.
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For non-physicians reading this Vaccine-related Information, TMA notes that the Vaccine-related Information does not substitute for the advice of a physician or other health care professional. Consulting a personal physician is always a good practice when faced with health issues to obtain specific medical advice taking into consideration each person’s medical situation. Persons should not rely on this information when dealing with personal health matters; rather medical advice from their own personal physician should be sought.