Six leading medical organizations and a pregnant physician have filed a federal lawsuit against Health and Human Services Secretary Robert F. Kennedy Jr, challenging his recent removal of COVID-19 vaccine recommendations for children and pregnant women as unlawful and dangerous to public health.
The case, American Academy of Pediatrics v Robert F. Kennedy, Jr., was filed July 7 in the US District Court for the District of Massachusetts. The plaintiffs include the American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Public Health Association (APHA), Infectious Diseases Society of America (IDSA), Massachusetts Public Health Alliance (MPHA), Society for Maternal-Fetal Medicine (SMFM), and an anonymous pregnant physician identified as Jane Doe.
Unprecedented Policy Changes Without Due Process
Kennedy announced May 27, 2025, that the CDC would stop recommending routine COVID-19 vaccines for pregnant women and healthy children. The health secretary claimed that no clinical data supports their use in children, while asserting without evidence that they are unsafe in pregnant women.
According to the lawsuit, Kennedy bypassed established federal procedures for vaccine policy changes. Typically, the Advisory Committee on Immunization Practices (ACIP) first meets to vote on such changes, which are then reviewed by the CDC director before becoming policy. However, Kennedy made these changes unilaterally without following the required process.
"This administration is an existential threat to vaccination in America, and those in charge are only just getting started," said Richard Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs. "If left unchecked, Secretary Kennedy will accomplish his goal of ridding the United States of vaccines, which would unleash a wave of preventable harm on our nation's children."
Sweeping Changes to Vaccine Advisory Committee
Less than two weeks after removing COVID-19 vaccine recommendations, Kennedy dismissed all 17 previous members of ACIP and replaced them with individuals including well-known vaccine skeptics. Among the new appointees are Robert Malone, MD, and Martin Kulldorff, PhD, both of whom have voiced skepticism towards vaccines and downplayed the severity of COVID-19.
The lawsuit accuses Kennedy of demonstrating "a clear pattern of hostility toward" established scientific processes and a disregard for expert opinion. Kennedy has also blocked CDC communications, cancelled vaccine panel meetings at the FDA and CDC without explanation, and initiated investigations into discredited links between vaccines and autism.
"The Department of Health and Human Services has historically been a trusted, essential partner of the AAP, which is why my pediatrician colleagues and I have grown increasingly alarmed as the nation's leading health care agency has become unrecognizable," said Susan J. Kressly, MD, FAAP, president of AAP. "Over the past several months, experts have been sidelined, evidence has been undermined, and our nation's vaccine infrastructure is now threatened."
Impact on Clinical Practice and Patient Care
The policy changes are already affecting clinical practice and patient counseling. Sindhu K. Srinivas, MD, MSCE, president of SMFM, emphasized that the federal directive pulling COVID-19 vaccine recommendations for pregnant individuals is "compromising the standard of care" and "has no evidentiary basis in obstetrics or infectious disease."
Peer-reviewed studies have shown that receiving the COVID-19 vaccine during any trimester reduces serious illness and hospitalization in pregnant individuals and their infants without showing any harm to the mother, pregnancy, or newborn. However, patients are now questioning not just COVID-19 vaccination, but also longstanding vaccines like influenza and Tdap during pregnancy.
"Without prompt and immediate intervention, these actions will continue to undermine the physician-patient relationship and jeopardize maternal and neonatal health outcomes," Srinivas said.
Jane Doe, the anonymous pregnant physician plaintiff from Massachusetts, is at risk of not receiving a COVID-19 booster during her pregnancy due to Kennedy's directive, despite being at high risk for infectious disease exposure in her hospital workplace.
Broader Public Health Concerns
The lawsuit comes as the US battles a measles outbreak with the highest number of annual cases recorded in 33 years. There have been three confirmed deaths from the disease, all in unvaccinated children. Kennedy has alternated between endorsing and shunning the MMR vaccine, which is proven to provide strong immunity against measles.
"The ongoing outbreak we are seeing in the US underscores the importance of maintaining adequate levels of measles vaccination," says International Vaccine Access Center (IVAC) executive director William Moss, who co-leads the measles tracking project. "The US is at risk of losing its measles elimination status should cases continue at this rate."
Pediatricians across the country are reporting increased parental concerns about vaccines and immunization schedules, with some parents expressing fear of losing access to vaccines entirely.
"It is really unconscionable to take away a parent's ability and choice to protect their children through vaccination, but that is exactly what Senator Kennedy's actions are doing by removing federal recommendations for COVID-19 vaccines as well as other vaccines," said Tina Tan, MD, FIDSA, FPIDS, FAAP, president of IDSA.
Legal Challenge and Sought Relief
The plaintiffs are seeking preliminary and permanent injunctions against the COVID-19 vaccine policy changes and a declaratory judgment that Kennedy's actions were unlawful. They argue that Kennedy has an agenda to "dismantle the longstanding, Congressionally authorised, science- and evidence-based vaccine infrastructure that has prevented the deaths of untold millions of Americans."
The lawsuit reads: "This is not a hypothetical concern, but a pressing public health emergency that demands immediate legal action and correction."
Public health experts have described the ACIP changes as creating a "dangerous" vaccine future in the US. The medical groups assert that the recommendation adjustment "immediately exposes these vulnerable populations" and represents an unprecedented departure from evidence-based public health policy.
"Quite frankly, this administration has both broken the law and is not providing good scientific evidence and policies," said Georges C. Benjamin, MD, executive director of APHA.
