Court Challenges Loom as RFK Jr. Cuts Covid Shot From CDC List

US Health Secretary Robert F. Kennedy Jr.'s decision to drop the Covid-19 vaccine from the CDC’s recommended immunization list for healthy children and pregnant women is spurring skepticism and likely to draw legal challenges.

Kennedy’s announcement, delivered Tuesday in a 58-second-long video on X, excluded officials from the Centers for Disease Control and Prevention, the agency responsible for setting the immunization schedule based on recommendations from the Advisory Committee on Immunization Practices.

The decision‘s lack of information to support the change runs into concerning administrative procedure practices, legal experts say. Kennedy appeared to not seek public comment before the decision, and if he received any feedback, it’s not clear from which stakeholders. Also unclear is which scientific studies or research were used to make the decision.

“He has the ability to make some pronouncements along these lines,” said Brian Dean Abramson, founding chair of the National Vaccine Law Conference. “But anything you’re doing that’s changing existing policy should be done procedurally through notice and comment process, through an extensive, public, and factually supported informational process.”

Kennedy’s history of vaccine skepticism and moves he’s made since taking control of the Department of Health and Human Services place his decisions around vaccinations under heightened scrutiny by public health advocates and the pharmaceutical industry.

“It should really be laid out in proper documentation that allows public input, public debate, and public understanding of what it is that they’re proposing,” said Peter Lurie, a former FDA associate commissioner for public health strategy and analysis who is now president of the Center for Science in the Public Interest.

The CDC did not respond to requests for comment on further details of the announcement.

Evidence Needed

Doctors, patient advocacy groups, and even states could find legal issues with Kennedy’s decision because the schedule affects whether physicians should give the Covid-19 vaccine to kids and pregnant women, and if health insurers should cover it with no cost-sharing.

The change will likely curtail access to the vaccine if health plans drop coverage or increase cost-sharing after no longer being required to pay for the shots, putting health plans in a tough spot with beneficiaries who are vulnerable to the virus or seeking to prevent it.

“The process used to have these vaccines removed, or I should say the lack of procedural guardrails, is new in FDA policy,” said Ana Santos Rutschman, a law professor at Villanova University. “If there is a successful challenge to this decision, I suppose it would be on procedural grounds.”

Other industry watchers found it odd that the announcement included FDA Commissioner Marty Makary and NIH Director Jay Bhattacharya, given their agencies don’t recommend vaccines, said Anthony Cox, professor emeritus at Indiana University.

The Food and Drug Administration licenses vaccines, and the National Institutes of Health conducts research to identify new vaccine candidates.

“They’re all announcing the change in CDC recommendations, but there’s no one from CDC,” said Cox, who researches how consumers make medical decisions.

It’s unclear who’s leading the CDC. Kennedy said May 14 in a Senate hearing the acting director is Matthew Buzzelli, but the agency’s website doesn’t list one. President Donald Trump nominated Susan Monarez, who has served as acting director, to lead the agency.

Industry Perspective

This decision could prompt challenges from vaccine makers that question what information the government used to determine that their shots no longer benefit certain patient populations.

“When they narrow the indication in the absence of new data, companies have a right to ask if they followed statutory requirements,” Lurie said. “I expect lawyers for large vaccine manufacturers will be examining that.”

It’s also possible manufacturers could view the decision as the government taking their vaccines, said James Hodge, a health law professor at Arizona State University.

“Pfizer and others made these vaccines to the tune of hundreds of millions of doses on the premise that they be used by the American public and globally,” Hodge said. “If I was assuring you that you could sell your product on the market, but then I prohibited that from occurring, you might have a claim to a regulatory taking.”

The government in that scenario would likely argue that certain populations don’t need access to those shots anymore and they aren’t fully taking vaccines away, Hodge said.

Novavax Inc. said it continues to monitor the ongoing regulatory and policy landscape for Covid-19 shots, and that market research and CDC statistics indicate that individuals 65 years and older and people with underlying conditions are most likely to seek out vaccination seasonally.

Vaccine makers Moderna Inc. and Pfizer Inc. did not respond to request for comment.