Health Secretary Robert F. Kennedy Jr.’s decision to remove recommendations that healthy children and pregnant women receive COVID-19 vaccines was illegal, a new lawsuit alleges.
The suit, filed in federal court in Massachusetts on July 7, said Kennedy’s directive is arbitrary and capricious, in violation of the Administrative Procedure Act, the American Academy of Pediatrics, and other doctors’ groups.
Kennedy announced on May 27 that the Centers for Disease Control and Prevention would stop recommending COVID-19 vaccination for healthy children and pregnant women. The CDC is part of the Department of Health and Human Services (HHS), which Kennedy leads.
Five days earlier, the suit notes, Kennedy said in his testimony to Congress, “My opinions about vaccines are irrelevant,” and “I don’t think people should be taking medical advice from me.”
Plaintiffs also pointed to how officials with the Food and Drug Administration, another division of HHS, around the same time, listed pregnancy as a condition that increases a person’s risk of severe COVID-19.
They portrayed Kennedy as overruling the agency, although FDA Commissioner Dr. Marty Makary appeared alongside Kennedy as he made the COVID-19 vaccine announcement.
They also took issue with how Kennedy did not ask a CDC vaccine advisory panel for advice before narrowing the recommendations.
“The Secretary failed to explain what prompted him to issue the Directive when he did,” the suit states. “The Directive states in the first paragraph that HHS ‘continually considers and evaluates available science and evidence related to … approved or authorized vaccines,’ but he failed to identify the available science or evidence that prompted him to issue the Directive when he did.”
The FDA in 2024 cleared the versions of the COVID-19 vaccines available at this time without clinical data. The vaccines were added to the childhood immunization schedule in 2023 and have been recommended for pregnant women for years.
Kennedy said in his announcement that the recommendations for annual shots came “despite the lack of any clinical data,” while Makary said that “there’s no evidence healthy kids need it today, and most countries have stopped recommending it for children.”
Some groups, such as the Independent Medical Alliance, cheered the move. Dr. Kay Lindley, an alliance director, said at the time that “there was no medical justification for keeping mRNA COVID-19 vaccines on the childhood and pregnant women’s schedules,” referring to the Pfizer and Moderna vaccines.
The alliance noted that a 2024 study analyzing the risk-benefit calculus for COVID-19 vaccines concluded there is little or no benefit for many people to receive COVID-19 vaccines, and that the risk of side effects, such as heart inflammation, means they should be withdrawn from circulation.
Other organizations, including the American Academy of Pediatrics, condemned the altered COVID-19 vaccine recommendations. In a motion for a preliminary injunction filed with the suit on Monday, they called on the court to immediately order the directive be rolled back.
“Unless the Secretary’s baseless and uninformed policy decision is vacated, pregnant women and children remain at grave and immediate risk of contracting serious illness,” they said.
The court documents said that COVID-19 vaccines are safe and effective, citing a CDC presentation delivered in June that estimated COVID-19 vaccines prevented emergency department and urgent care visits in some children who received an updated vaccine, and estimated infants born to mothers who received a vaccine while pregnant were less likely to be admitted to a hospital for a COVID-19-associated reason.
Andrew Nixon, an HHS spokesperson, told The Epoch Times in an email that “the Secretary stands by his CDC reforms.”