US Vaccine Policy in Turmoil: FDA Reverses on Moderna mRNA Flu Shot as Advisory Committee Collapses

The FDA reversed its initial decision to decline consideration of Moderna's mRNA flu vaccine, agreeing to proceed with a normal review after public backlash against the original rejection. In a separate but concurrent upheaval, a federal judge invalidated the appointment of 13 members of the federal vaccine advisory committee, leaving the United States without a functioning ACIP and throwing several key vaccine recommendations into limbo.

The FDA's initial decision not to consider Moderna's new mRNA flu vaccine was described as precedent-breaking. Hundreds of millions of dollars had been invested to develop the shot, and the clinical trial — conducted according to terms backed by the agency in 2024 — showed the vaccine achieved 26.6 percent greater efficacy than the standard flu shot. The original rejection, personally made by the head of the Center for Biologics Evaluation and Research, threatened the broader pipeline of future vaccine development by destabilizing the regulatory framework drugmakers rely on. FDA Commissioner Marty Makary acknowledged the situation when he suggested the agency might eventually approve the vaccine, and it was subsequently confirmed the FDA would proceed with a normal review. Several companies had already announced plans to pull back on vaccine research in response to the original decision.

Meanwhile, a federal judge stayed the appointment of 13 members of the Advisory Committee on Immunization Practices (ACIP), ruling they were unqualified and not selected properly. The advisers had been hand-picked by HHS Secretary Robert F. Kennedy Jr. after he fired the previous 17 ACIP members in June. With the ruling, the US has no functioning advisory committee, and several key vaccines are no longer recommended — including the latest versions of flu and COVID shots and the inclusion of the RSV shot for infants in the federal Vaccines for Children program, which covers immunizations for more than half of US children.

Those immunizations remain on the market, but pharmacists in some states may be wary of administering them. Physicians and pharmacists are protected from liability around administering COVID vaccines under the Prep Act as long as the shots are recommended by the CDC and ACIP. While some states allow pharmacists to give shots recognized by outside organizations like the American Academy of Pediatrics, others have limits on pharmacy administration when the ACIP does not recommend the shots.

Robert Malone, a controversial figure who had served as former co-chair of the committee, said he would not participate in any future ACIP decisions, citing unpaid labor, hatred, and sabotage. HHS plans to add new members to the vaccine committee in a process expected to take four to six months. In the meantime, the routine childhood vaccine schedule has been restored.

Trust in the CDC has declined sharply, falling from 63 percent in September 2023 to 59 percent in April 2025, and to 47 percent in the most recent polling, with a larger share of Democrats abandoning faith in the agency than Republicans seeing it restored. HHS has indicated it intends to appeal the court ruling, and the American Academy of Pediatrics has signaled it will continue to challenge the selection process.