ICAN’s Roadmap for Immediate Vaccine Reform
Updated
Driven by its ongoing goal of providing every person with the right to informed consent, on June 30, 2026, attorneys for Informed Consent Action Network (ICAN) sent Secretary of Health and Human Services (HHS) Robert F. Kennedy Jr. a two-page letter titled “Immediate Vaccine Reforms.” Prepared by attorneys Aaron Siri and Elizabeth Brehm of Siri & Glimstad, the straightforward “cheat sheet” is intended to serve as a practical roadmap for immediate vaccine reform by consolidating requests that ICAN has made over preceding months. The letter groups its proposals into those the Secretary can order immediately, those that require notice-and-comment rulemaking, and those that would need White House approval. Many of the steps outlined in the letter need neither new legislation nor a lengthy regulatory process.
The immediate action list opens with a call to repeal the PREP Act declaration covering COVID-19 countermeasures. Even though Secretary Kennedy has signed determinations terminating the Emergency Use Authorization (EUAs) declarations, the liability immunity for COVID-19 vaccine manufacturers, distributors, and those who administer these products is governed by the Public Readiness and Emergency Preparedness (PREP) Act and remains in force. The PREP Act declaration for COVID-19 countermeasures was last amended in December 2024 and runs through December 31, 2029. Meaning, until it is repealed or amended to exclude them, it continues to shield COVID-19 jabs from liability for everything short of willful misconduct.
Several of ICAN’s requests revolve around information that the department already has in its possession. The letter asks HHS to remove identifying patient details from every health-related database it has access to and to release those records so independent researchers can review the government’s own data. It also asks that the CDC expand the Vaccine Information Statements to list every ingredient and the adverse events already named in Section 6.2 of each product’s package insert. Likewise, it requests that HHS retract or remove MMWR articles and other CDC publications that rely on underlying data that has never been released to the public (sounds logical), and to direct the revived Task Force on Safer Childhood Vaccines to issue recommendations. The letter also suggests requiring that designs for HHS-funded studies be posted before work begins and that all results be published.
The immediate list also extends to personnel and program administration. The letter asks that Freedom of Information Act offices within HHS adopt specific procedures laid out by ICAN in its March 2026 Task Force letter, recommends that HHS employees sign a no-conflict-of-interest pledge, and that the Health Resources and Services Administration implement significant changes to how it runs the Vaccine Injury Compensation Program. Along with that, two of the requests are stated more bluntly: the letter asks that every employee in the FDA’s Center for Biologics Evaluation and Research who was previously involved in licensing any childhood vaccine be fired, along with terminating the employment of every employee in the CDC’s Immunization Safety Office.
A second group of proposals would require a formal notice-and-comment period before taking effect. The letter asks HHS to update the Vaccine Injury Table to add injuries that should already be listed, as required by federal law. Likewise, it asks it to revise FDA rules so that direct-to-consumer broadcast advertising fully discloses known harms, and to issue a regulation that would require providers and manufacturers to report any adverse event or suspected adverse event that occurs within 60 days of vaccination to the Vaccine Adverse Event Reporting System (VAERS), without first conducting a causation analysis.
The last two items would need White House approval. Both concern how vaccines get recommended.
The first reform is to reconstitute the Advisory Committee on Immunization Practices (ACIP). The recommendations of this federal panel shape the childhood vaccine schedule, insurance coverage, and school requirements. In June 2025, Secretary Kennedy replaced the controversial members of the committee, but a federal court paused those appointments in March 2026. Thus, the panel has been tied up in litigation. ICAN asks that new members be appointed so that it can resume its function.
The second item of reform asks that, once ACIP is reconstituted, it considers placing all vaccines, or at least those that do not stop transmission, into a category called “shared clinical decision-making.” Currently, most vaccines carry a blanket routine recommendation, meaning the government advises that everyone in a given group should get them regardless of individual circumstances. Shared decision-making replaces that with a case-by-case choice made between a patient and doctor. This change is particularly important because government recommendations do not stay advisory—they shape school requirements and insurance coverage. It is much harder to mandate a vaccine that isn’t recommended for everyone. The letter singles out vaccines that do not stop transmission because the main argument for recommending a shot to the entire population is that it protects other people by stopping the disease spread. However, ICAN contends that especially when that rationale does not hold, the decision belongs to the individual.
In a November 4, 2026 press release, ICAN pulled seven of the twenty reforms requested in its letter to the front as examples of what it hopes to accomplish in the name of informed consent. They are: repealing the COVID-19 PREP Act declaration; de-identifying and publicly releasing HHS health databases; directing the FDA to set minimum safety standards for vaccine licensure; requiring every HHS-funded study to publish its design and all of its results; directing HRSA to properly administer the Vaccine Injury Compensation Program; firing CDC Immunization Safety Office staff “who failed to do their job”; and firing FDA CBER employees who “played a role in licensing childhood vaccines based on inadequate safety trials.” These, the organization wrote, “are not aspirational goals,” but “immediate actions HHS can take right now.”