The removal of recommendations for pregnant women and healthy children violate federal law, according to the lawsuit.
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.”
