RFK Jr Linked Group Asks FDA to Revoke COVID Vaccine Authorizations

Children's Health Defense, the nonprofit founded by Health Secretary Robert F. Kennedy Jr., filed a citizen petition with the Food and Drug Administration this week asking the agency to deem the Pfizer and Moderna COVID 19 vaccines misbranded and to revoke their licenses for lack of compliance with FDA regulations. By statute the petition compels the agency to provide a formal response, setting the stage for a legal and regulatory confrontation with potentially wide reaching implications for public health policy.

The petition, according to filings, does not rest on new scientific claims about safety or efficacy. Instead it advances procedural arguments about the history of authorization and regulation of the mRNA vaccines, asserting that regulatory steps taken since the initial emergency use authorizations did not meet statutory requirements. The practical effect would be to strip the two leading vaccine makers of the federal approvals that have governed distribution and recommendations since the first years of the pandemic.

The filing lands amid a broader reordering of federal vaccine policy under Secretary Kennedy and comes as the FDA has expanded an inquiry into deaths that may be associated with the COVID 19 vaccines, including cases in adults. HHS said the FDA is reviewing the petition and will respond directly to the petitioner. Officials have not indicated a timeline for that response.

Public health experts and clinicians immediately cautioned that an action to remove vaccines from the market would be historic and likely damaging. Removing long used vaccines would risk eroding public confidence, complicating clinical practice for physicians caring for people at high risk of severe disease, and hampering the nation’s readiness to respond to future variants. Epidemiologists note that vaccines remain a primary tool for preventing hospitalizations and deaths even as therapeutic options and population immunity evolve.

The petition also intensifies political scrutiny of the Health and Human Services agenda. Since his confirmation Secretary Kennedy has overseen a series of shifts in advisory recommendations and federal guidance, and the citizen petition from a group he founded adds a layer of legal pressure that could influence regulatory choices or invite litigation. The petition will require the FDA to engage with legal claims about how approvals and labeling were handled, a process that could play out in the agency record and possibly in federal court.

For clinicians and hospitals the immediate concern is operational uncertainty. Vaccine programs at hospitals, clinics, and pharmacies rely on federal approvals and guidance to inform supply decisions, insurance reimbursement, and patient counseling. Any sudden change to authorizations could create logistical challenges and deepen vaccine hesitancy among populations already reluctant to accept new recommendations.

The next formal step is the FDA response to the petition, which will clarify whether the agency views the claims as warranting regulatory action or further investigation. If the agency decides against revoking authorizations the petitioners may pursue litigation, prolonging the dispute. Whatever the outcome, the episode underscores how legal strategies can now be deployed alongside scientific debate to shape the future of pandemic policy.