Doctors’ groups sue Kennedy over Covid shot changes for kids, pregnant people

A coalition of doctors’ groups led by the American Academy of Pediatrics filed a lawsuit Monday against Health Secretary Robert F. Kennedy Jr., arguing that his May announcement that the government would no longer recommend Covid-19 vaccines for healthy pregnant people and children violated longstanding norms governing U.S. immunization policy.

The organizations say Kennedy’s May 19 “Secretarial Directive” documenting his move to pull the vaccine from the CDC’s immunization schedule constitutes a final agency action ripe for challenge, noting that he cited no emergency or specific circumstantial changes to support the move.

“The Secretarial Directive is contrary to the wealth of data and peer-reviewed studies that demonstrate the safety and efficacy of Covid vaccines for children and pregnant women,” the plaintiffs said in the lawsuit.

HHS didn’t immediately respond to a request for comment.

Organizations on the challenge include the American College of Physicians, the American Public Health Association and the Infectious Diseases Society of America.

The directive, they wrote, has put doctors “in the untenable position of telling their patients that the country’s top-ranking government health official’s advice and recommendations are wrong and that we are right.”

“This erodes trust, which is the foundation of a healthy physician-patient relationship and vital to the success of AAP members’ medical practices,” they added.

The groups are asking a federal judge to order the restoration of the Covid vaccine recommendations to the immunization schedules for children and for pregnant people and to bar HHS from enforcing or publicizing the May directive.

“Pediatricians cannot stay silent as the system we rely on to support lifesaving vaccines is chiseled away piece by piece,” AAP President Susan Kressly told reporters after the lawsuit was filed. “With Secretary Kennedy leading efforts to sow doubt and distrust in the American success story of vaccines, we are on a dangerous path.”

Kennedy announced the change in a May 27 video posted to X, in which he was flanked by FDA Commissioner Dr. Marty Makary and NIH Director Dr. Jay Bhattacharya, both of whom gained notoriety during the Covid pandemic for their opposition to mask and vaccine mandates.

The three officials said there wasn’t sufficient data to show healthy children and healthy pregnant women benefited from Covid vaccination. “Most countries have stopped recommending it for children,” Makary said in the video.

The administration later distributed a document explaining the decision to lawmakers. The document said studies have shown that women who got the vaccine during pregnancy had higher rates of various complications, but authors of those studies told POLITICO that the administration had misinterpreted their results.

The plaintiffs in the case said Kennedy had unlawfully sidelined the CDC and its independent vaccine panel, the Advisory Committee on Immunization Practices, which are the federal bodies responsible for the immunization schedule.

“The statutory scheme that regulates the vaccine infrastructure in this country demonstrates Congress’ repeated policy decision to require that ACIP recommendations, made by a fairly balanced ACIP membership, be the basis for what is put on or taken off of the CDC immunization schedules — not the unilateral decision of a single individual,” the plaintiffs wrote.

Public and private insurers are largely obligated to cover ACIP-recommended vaccines with no cost-sharing under the Affordable Care Act, and states often tie their daycare and school vaccine requirements to the panel’s recommendations.

While the CDC ultimately didn’t pull the recommendation from the childhood schedule, it did downgrade it to one involving “shared decisionmaking” — a differentiation the physician groups say has made it harder for providers to counsel patients and for practices to assess insurance coverage.

Monday’s lawsuit doesn’t directly challenge Kennedy’s decision last month to fire all 17 ACIP members and replace them with several vaccine skeptics. But Richard Hughes, an Epstein Becker Green attorney representing the plaintiffs, told reporters he expects future HHS decisions finalizing recommendations by the new panel will spur them to “amend our complaint to reflect those injuries.”

The Supreme Court ruled 6-3 last month to preserve a preventive health coverage provision of the Affordable Care Act that was based on a different advisory panel’s recommendations. But the decision emphasized the HHS secretary’s authority to reject or slow-walk U.S. Preventive Services Task Force recommendations, and Kennedy is widely seen as having broad power to remake ACIP specifically as he sees fit.

Still, Dr. Georges Benjamin, APHA’s executive director, said the groups hope “this lawsuit will force them to go back to providing a rational, scientifically evidence based, transparent process to decision-making.”

If Kennedy is “not relying on sound science — if we’re seeing pretext and bias running roughshod over really important, longstanding processes and procedures — that’s arbitrary and capricious, and that is unlawful,” Hughes added.

The AAP’s lawsuit was filed in federal district court in Massachusetts, where a landmark vaccine policy case set national precedent in the early 20th century. The Supreme Court’s 1905 Jacobson v. Massachusetts decision upheld states’ authority to mandate vaccinations.

Many states, such as Massachusetts, also tie their legal scopes of practice for pharmacists to prescribe and administer vaccines to ACIP’s recommendations, Hughes said.

“It is an immediate disconnect, it’s an immediate disintegration of laws that rely on ACIP recommendations, and that is what is causing the injury,” he said. “There’s a whole chain reaction to the secretary’s actions.”

The case has been assigned to Judge William Young, a Reagan-era appointee overseeing a First Amendment case challenging the Trump administration’s bid to deport pro-Palestinian academics.

Josh Gerstein contributed to this report.