Medical Groups’ Suit Seeks to Reverse COVID Vaccine Guidance

Alleging that US Department of Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr, is undermining vaccine confidence, six medical societies and an individual female physician have sued to reverse his decision on COVID-19 vaccines for pregnant women and healthy children.

The lawsuit, filed in US District Court in Massachusetts, said that Kennedy’s announcement on X that he was removing COVID-19 vaccine guidance for pregnant women from the CDC immunization schedule and suggesting shared decision-making for healthy children, was “arbitrary and capricious,” and thus a violation of the law that guides federal actions.

Kennedy’s move was in “direct contradiction of multiple federal and state laws that require reliance on ACIP [Advisory Committee on Immunization Practices] recommendations for the CDC immunization schedules, not the decisions of a single individual like the Secretary,” according to the 42-page complaint.

The plaintiffs cited multiple instances of what they allege are Kennedy’s attempts to stoke skepticism and promote misinformation about vaccines, including his firing of all 17 ACIP members in early June.

When asked to comment on the suit by Medscape Medical News, HHS spokesman Andrew Nixon said that “the Secretary stands by his CDC reforms.”

Those who joined the suit — the American Academy of Pediatrics (AAP), American College of Physicians, American Public Health Association (APHA), Infectious Diseases Society of America, Massachusetts Public Health Association, the Society for Maternal-Fetal Medicine (SMFM), and a Jane Doe — said the changes in the vaccine schedule were leading to confusion among patients.

Jane Doe, a physician working in a hospital who is more than 20 weeks pregnant and at heightened risk of exposure to infectious disease, said she worried that Kennedy’s actions meant that she would not be able to get a COVID booster later in her pregnancy.

In a briefing with reporters, AAP President Susan Kressly, MD, said that among parents, “there is doubt and uncertainty about what this recommendation means and what shared decision-making means.” The change in the immunization schedule “is causing uncertainty and anxiety at almost every pediatric visit that involves vaccines,” said Kressly.

Sindhu K. Srinivas, MD, MSCE, president of the SMFM, told reporters that Kennedy’s decision to drop a recommendation for pregnant women “has no evidentiary basis in obstetrics or infectious disease.” Peer-reviewed studies show “that administration of the vaccine during any trimester in pregnancy lowers hospitalization rates, serious illness and adverse outcomes” for women and infants, she said, adding that studies also “show no harm to the pregnant patient, the pregnancy or the newborn resulting from administration of the COVID-19 vaccination during pregnancy.”

APHA Executive Director Georges C. Benjamin, MD, said “this administration has both broken the law and is not providing good scientific evidence and policies.” The APHA joined the suit “to stop these disproven theories that are driving policymaking decisions,” said Benjamin.

The American Medical Association and the American College of Obstetricians and Gynecologists did not join the suit, although both organizations have been critical of Kennedy and the changes to the immunization schedule and the ACIP membership.

Richard Hughes, the lead attorney for the plaintiffs, told reporters that he hopes to get a hearing on the case within 2 weeks. A final decision could come by September, but that is “subject to any appeals,” said Hughes. 

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.