Six major medical organizations — including the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), and the Society for Maternal-Fetal Medicine (SMFM) — filed a federal lawsuit Monday against the Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr., accusing them of making “unilateral and unlawful” changes to federal vaccine policy.
The lawsuit, filed in the U.S. District Court for the District of Massachusetts, also includes a pregnant physician as a plaintiff. The suit seeks an immediate injunction to block Kennedy’s revised COVID-19 vaccine recommendations and a ruling declaring the changes unlawful.
The plaintiffs argue that Kennedy and the HHS have undermined vaccine access and public trust by withdrawing key recommendations — including those related to COVID-19 shots for pregnant women and healthy children — without following the standard federal rulemaking process.
“He’s been on a warpath,” said Richard H. Hughes IV, lead counsel for the plaintiffs and a partner at Epstein Becker Green. “This decision to upend COVID vaccine guidance based on bias, not science, is arbitrary, capricious, and illegal.”
The lawsuit claims HHS violated the Administrative Procedure Act, which governs how federal agencies issue rules and regulations.
In response, an HHS spokesperson said, “The Secretary stands by his CDC reforms.”
Controversial Policy Shift
In late May, the FDA announced plans to restrict access to future COVID-19 vaccines to those over 65 or with underlying health conditions. The agency also said vaccine manufacturers would now need to conduct larger studies before expanding use to children and healthy adults.
About a week later, without a vote from the CDC’s vaccine advisory committee, Kennedy abruptly announced that COVID-19 vaccines were no longer recommended for healthy children or pregnant women. Instead of an official agency announcement, the update appeared in a video posted on X (formerly Twitter), catching doctors and public health experts off guard.
In the video, Kennedy claimed there was “no clinical data” supporting repeat COVID booster shots in children — a claim that drew immediate backlash from the medical community.
One plaintiff, a pregnant doctor working in a hospital setting, expressed concern that Kennedy’s recommendation could block her from accessing a COVID-19 vaccine during pregnancy — putting both her and her unborn child at greater risk, according to court documents.
Fallout From Vaccine Panel Shakeup
The lawsuit also slams Kennedy’s decision to disband the CDC’s Advisory Committee on Immunization Practices (ACIP), removing all 17 members and replacing them with seven new appointees — a move critics say has injected politics and skepticism into what was once a science-based body.
Kennedy defended the shakeup, saying it was a “clean sweep” meant to restore public trust. However, some of the new members have previously expressed anti-vaccine views, especially around COVID-19 and mRNA technology.
During the first ACIP meeting under new leadership, chair Martin Kulldorff announced two new working groups — one to re-examine the long-term effects of the full childhood vaccine schedule, and another to review vaccines that haven’t undergone formal re-evaluation in more than seven years.
One potential topic: whether newborns still need the hepatitis B vaccine before hospital discharge — a policy that infectious disease experts credit with drastically reducing transmission of the virus among children.
Outrage from the Medical Community
Leading public health voices say the administration’s approach is undermining decades of trust and progress.
“These changes are not rooted in science or evidence, but in fear,” said Dr. Susan J. Kressly, president of the American Academy of Pediatrics. “They will leave children more vulnerable to preventable diseases like measles, pertussis, and influenza.”
“Every moment these dangerous directives remain in effect, they put high-risk pregnant patients at greater risk of serious illness and erode public confidence in vaccines,” added Dr. Sindhu K. Srinivas, president of SMFM.
The plaintiffs argue that Kennedy’s actions not only threaten public health but also violate legal norms that protect against arbitrary decision-making by federal agencies.
As the lawsuit moves forward, it signals a growing rift between the scientific and medical communities and the current leadership at HHS — one that could have long-term consequences for how Americans access and trust vaccines.
