Six medical groups today sued the Department of Health and Human Services (HHS) and HHS Secretary Robert F. Kennedy Jr. in a US district court in Massachusetts for acting "arbitrarily and capriciously" in making recent changes to COVID-19 vaccine policy.
The plaintiffs also include an unnamed pregnant doctor who is at immediate risk for being unable to receive a COVID-19 booster, based on the recommendations that Kennedy announced unilaterally in May. The doctor contends that she is at high risk for exposure to infectious disease due to her job working as a hospital-based physician. The groups that signed onto the lawsuit are the American Academy of Pediatrics (AAP), the American College of Physicians (ACP), the American Public Health Association (APHA), the Infectious Diseases Society of America (ISDA), Massachusetts Public Health Alliance (MPHA), and the Society for Maternal-Fetal Medicine (SMFM).
On May 27, Kennedy announced sweeping changes in US vaccine policy, including the removal of the Centers for Disease Control and Prevention (CDC) COVID-19 recommendation for healthy children and pregnant women. The move came a week after the Food and Drug Administration announced that the COVID-19 vaccine would be recommended only for adults ages 65 and older and others who have health conditions that make them most susceptible to infection complications. In both instances, the decisions were made without input from federal vaccine advisory groups.
A few weeks later, Kennedy removed 17 members of the CDC's Advisory Committee on Immunization Practices (ACIP), replacing them with eight members, including several of Kennedy's anti-vaccine allies.
The lawsuit filed today is the latest among a handful of efforts to push back against Kennedy’s assault on vaccines. Others include the launch of the Vaccine Integrity Project (VIP), a group of leading public health experts that defend vaccination and make recommendations on how nongovernmental agencies can help make sure that vaccine recommendations remain grounded in the best available science, free of external influence.
The project is led by a steering group brought together by the Center for Infectious Disease Research and Policy (CIDRAP), which publishes CIDRAP News, and is supported by Alumbra, a foundation established by philanthropist Christy Walton.
Charges: Unlawful changes undermine vaccine science
Along with the charge that Kennedy acted arbitrarily and capriciously when changing the COVID-19 vaccine recommendations, the plaintiffs say Kennedy unjustly dismissed the 17 previous ACIP members. The plaintiffs, in a statement from the ACP, added that, since then, the committee has undermined the science behind vaccine recommendations.
In its first recommendations on June 26, Kennedy's hand-picked panel recommended against receiving flu vaccines that contain the preservative thimerosal, reviving a hot-button topic of anti-vaccine groups. More than 40 studies over many decades have found no link between thimerosal and developmental delays, but the CDC and AAP asked vaccine manufacturers to remove the preservative in 1999 to bolster confidence in vaccines, not because the ingredient is harmful.
The lawsuit asks for preliminary and permanent injunctions to halt Kennedy's COVID vaccine recommendations and to declare that the changes are unlawful.
Richard Hughes IV, partner at Epstein Becker Green and lead counsel for the plaintiffs, said in the statement, "This administration is an existential threat to vaccination in America, and those in charge are only just getting started. 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."
The lawsuit contends that coordinated actions by HHS and Kennedy were designed to mislead, confuse, and gradually desensitize the public to anti-vaccine and anti-science rhetoric. It also contends that Kennedy has widely flouted federal procedural rules, including blocking CDC communications, cancelling federal vaccine advisory group meetings without explanation, and announcing studies to probe non-existent links between vaccines and autism.
Plaintiffs cite lack of evidence, threats to patients
Susan Kressly, MD, president of the AAP, said the group is alarmed by recent HHS decisions to change the childhood immunization schedule.
"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," she said.
Jason Goldman, MD, president of the ACP, said the group is highly concerned about the administration's recent actions regarding ACIP and the negative impact it will have on patients and physician practices. "As physicians, we require reliable, science-based guidance that is based on the best available evidence, developed through an evidence-based and transparent process, to ensure the safety, welfare, and lives of our patients," he added.
Editor's note: This article was modified on July 8 to clarify the status of the pregnant doctor's COVID booster status.
