Robert F. Kennedy Jr. has promised to follow established rules for vaccine approvals as he leads the country’s top health agencies, but his administration is already introducing sweeping changes that may slow or complicate access to future vaccines.

FDA Commissioner Marty Makary says the agency is preparing a major overhaul of how vaccines are tested and approved, led by new vaccine chief Dr. Vinay Prasad, who has been critical of how COVID-19 boosters were handled. Though details haven’t been made public, the new direction has already delayed full approval of Novavax’s COVID shot and led to unexpected restrictions on its use.

The FDA now argues that even small updates to match new variants could require fresh testing, a stance that could impact this fall’s booster rollout. Other health agencies are also shifting. The CDC has yet to act on recent recommendations for new meningitis and RSV shots, and Kennedy allies have signaled a likely end to COVID booster guidance for children.

Critics say the moves reflect Kennedy’s long-standing skepticism toward vaccines. At a Senate hearing, he wrongly claimed only COVID vaccines were tested against placebos—prompting Republican Sen. Bill Cassidy to correct the record. Public health experts warn the administration’s approach may fuel misinformation and delay vaccine availability.

Behind the scenes, FDA scientists say political appointees overruled their recommendation to approve the Novavax shot last month. The final approval came only after added restrictions and a demand for new trials—steps some called unprecedented. Meanwhile, Moderna has postponed its new COVID-flu combo vaccine after regulators requested more data.

As the FDA prepares to meet Thursday to decide on updated COVID shots for the coming season, uncertainty remains over how the new rules will affect vaccine access and public trust.

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