Several prominent medical organizations have filed a lawsuit against the Department of Health and Human Services (HHS) and Secretary Robert F. Kennedy Jr. This legal action is in response to what the organizations are describing as “illegal and unilateral alterations to vaccine protocols.” The lawsuit was filed on Monday in the U.S. District Court for the District of Massachusetts by six groups, including the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), and the Society for Maternal-Fetal Medicine (SMFM), along with a pregnant woman.
The organizations, which represent pediatricians, infectious disease specialists, and public health professionals, have accused HHS and Secretary Kennedy of deliberately removing certain vaccines, such as the COVID-19 vaccine, and replacing the entire vaccine advisory panel of the Centers for Disease Control and Prevention (CDC). The lawsuit seeks both preliminary and permanent injunctions to stop Kennedy’s new COVID vaccine recommendations and a declaratory judgment stating that the changes are unlawful.
According to Richard H. Hughes IV, lead counsel for the plaintiffs, Kennedy’s actions have been seen as highly concerning, prompting the need for legal intervention. The lawsuit alleges that HHS violated the Administrative Procedure Act, a federal law that governs the rule-making process for federal agencies.
In late May, the U.S. Food and Drug Administration announced plans to restrict access to future COVID vaccines to individuals aged 65 and older and those with underlying health conditions. HHS indicated that the COVID-19 public health emergency had officially ended, leading to a shift in the approach to vaccine approval under the Biden administration.
Kennedy later made changes to COVID-19 vaccine recommendations for healthy children and pregnant women without committee approval, breaking tradition by announcing the decision through unofficial channels. He claimed there was insufficient clinical data to support repeat booster shots for children.
One of the plaintiffs, an anonymous pregnant woman who is also a physician, has been unable to receive a COVID-19 vaccine since Kennedy’s announcement. This situation poses significant risk to her as a hospital worker potentially exposed to infectious diseases.
Overall, the lawsuit aims to address concerns raised by the medical community regarding the abrupt changes in vaccine recommendations under Secretary Kennedy’s leadership.
Dr. Sindhu K. Srinivas, president of the SMFM, expressed concern about the impact of decisions related to the COVID-19 vaccine on patient care. She emphasized that delays in addressing these concerns could pose risks to high-risk pregnant patients’ access to the vaccine and erode trust in vaccination recommendations. Recent changes made by Kennedy, including the removal and replacement of members on the CDC’s ACIP, have raised alarm among plaintiffs and health experts. While Kennedy stated that the replacements would not be against vaccines, some new members have shown anti-vaccine sentiments, particularly regarding COVID-19 vaccines and mRNA technology. The ACIP plans to establish work groups to assess various vaccine-related issues, including the necessity of the hepatitis B vaccine at birth. These changes have drawn criticism from organizations like the American Academy of Pediatrics, which believes that altering the childhood immunization schedule without evidence-based reasoning could increase vulnerability to infectious diseases.
