Medical Societies Sue HHS, Secretary Kennedy Over Changes in COVID-19 Vaccine Guidance

Leading medical societies across the United States, including the American Academy of Pediatrics (AAP), American College of Physicians (ACP), Infectious Diseases Society of America (IDSA), American Public Health Association (APHA), Massachusetts Public Health Alliance (MPHA), Society for Maternal-Fetal Medicine (SMFM), and an anonymous pregnant physician, have filed suit against the Department of Health and Human Services (HHS) and its secretary, Robert F. Kennedy Jr., over actions the agency took on COVID-19 vaccination recommendations, according to a news release from APHA.¹

Sign of U.S. Department of Health & Human Services (HHS) at its headquarters building in Washington, D.C. | Image Credit: © JHVEPhoto - stock.adobe.com

Details of the Lawsuit

The suit, American Academy of Pediatrics v. Robert F. Kennedy, Jr., was filed in the US District Court for the District of Massachusetts. The suit also includes as defendants Marty Makary, commissioner of the FDA; Jay Bhattacharya, director of the National Institutes of Health (NIH); and Matthew Buzzelli, the acting director of the CDC, along with their respective agencies.²

The plaintiffs allege that Kennedy, in his role as HHS Secretary, violated the Administrative Procedure Act when he issued new guidance for COVID-19 vaccines, stating that the CDC would no longer recommend that healthy children and pregnant individuals receive routine COVID-19 vaccinations. According to the plaintiffs, the directive by Kennedy was “arbitrary and capricious” and was issued “in contravention of science and clinical expertise.”^2,3

Plaintiff Jane Doe, the anonymous pregnant physician, joined the societies in the suit. Doe alleges that the directive by Secretary Kennedy to alter COVID-19 vaccine recommendations “has and will make it more difficult for her to get a COVID vaccine while she is pregnant, which in turn will endanger her unborn child,” according to the suit.^1,2

Further, they argue that Kennedy’s usurpation of the Advisory Committee on Immunization Practices (ACIP)—the body that traditionally makes recommendations on vaccines to include on the CDC’s immunization schedule—was unlawful and “contravenes” the precedent that political appointees such as Kennedy “not meddle in deciding what vaccines” are included on the schedule. By doing so, the plaintiffs argue, “the Directive…is not in accordance with the law,” and it has “injured all the Plaintiffs” included in the suit.^2,4

The parties are asking for injunctions to prevent Secretary Kennedy’s COVID-19 vaccine recommendations from going into effect, along with a declaration pronouncing the changes in guidance as unlawful, according to the APHA.^1,2

“The American Academy of Pediatrics is alarmed by recent decisions by HHS to alter the routine childhood immunization schedule,” Susan J. Kressly, MD, FAAP, president of the AAP, said in a statement. “These decisions are founded in fear and not evidence and will make our children and communities more vulnerable to infectious diseases like measles, whooping cough, and influenza.”¹

Guidance Changes Not Backed Up by Extensive Research

In May, Secretary Kennedy announced in a video posted on X the changes to the COVID-19 recommendations for children and pregnant individuals. Prior to the change, the CDC recommended that everyone 6 months and older receive a routine COVID-19 vaccine, including pregnant individuals, who are at higher risk of severe COVID-19 due to the many bodily changes experienced during pregnancy. Extensive research has confirmed the risk that pregnancy can pose to those infected with COVID-19, increasing the likelihood of preeclampsia, preterm birth, and stillbirth.³

Changes in guidance directed by Secretary Kennedy are seemingly at odds with the litany of evidence indicating increased risk due to COVID-19 in pregnant individuals and the strong protection they receive from available COVID-19 vaccines. The organizations allege that the guidance alterations were deliberately designed to “mislead, confuse, and gradually desensitize the public to anti-vaccine and anti-science rhetoric.”^1,3

Regardless of the outcome of their suit, the suing organizations “urge parents and patients to follow their qualified medical professionals’ vaccine guidance.” Pharmacists play a critical role in educating patients on the most up-to-date, fact-based guidance on COVID-19 and other vaccines. Vast amounts of studies have confirmed the effectiveness of vaccines in preventing severe illness and death; pharmacists, often trusted in the community, are in a prime position to advocate for and counsel patients regarding vaccination.^1,3

REFERENCES

1. American Public Health Association. APHA Joins Others to Sue HHS, Robert F. Kennedy, Jr. for Unlawful, Unilateral Vaccine Changes. News Release. Released July 7, 2025. Accessed July 8, 2025. https://www.apha.org/news-and-media/news-releases/apha-news-releases/apha-joins-others-to-sue-hhs,-robert-f-kennedy,-jr-for-unlawful,-unilateral-vaccine-changes

2. US District Court for the District of Massachusetts. American Academy of Pediatrics vs. Robert F. Kennedy, Jr. Case No. 1:25-cv-11916. Filed July 7, 2025. Accessed July 8, 2025. https://downloads.aap.org/AAP/PDF/FiledSuit.pdf

3. Halpern L. CDC to end COVID-19 vaccine recommendation for healthy children, pregnant women. Pharmacy Times. Published May 27, 2025. Accessed July 8, 2025. https://www.pharmacytimes.com/view/cdc-to-end-covid-19-vaccine-recommendation-for-healthy-children-pregnant-women

4. Halpern L. Department of Health and Human Services reconstitutes ACIP, removing 17 sitting members. Pharmacy Times. Published June 10, 2025. Accessed July 8, 2025. https://www.pharmacytimes.com/view/department-of-health-and-human-services-reconstitutes-acip-removing-17-sitting-members