Pediatricians, public health leaders sue to nix new vaccine schedule as RFK Jr. appoints 2 OB/GYNs to ACIP

Two obstetrician-gynecologists will join the Advisory Committee on Immunization Practices (ACIP).

Meanwhile, a war of words between Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and the American Academy of Pediatrics (AAP) will become a court fight over changes to the nation’s childhood vaccine schedule. The AAP recently sued to stop the next ACIP meeting, scheduled for Feb. 25 and 26, and is seeking a court order to vacate Jan. 5 changes to the nation’s newest pediatric immunization schedule.

The actions were the latest involving vaccines, which have become a flashpoint between medical experts and federal leaders in U.S. health care.

New ACIP members

Kennedy announced the appointments on Jan. 13.

“ACIP serves as Americans’ watchdog for vaccine safety and transparency,” Kennedy said. The newest appointees, Adam Urato, M.D., and Kimberly Biss, M.D., FACOG, “bring the scientific credentials, clinical experience, and integrity this committee requires,” he said.

The new members are as follows:

• Urato is an obstetrician and gynecologist specializing in maternal-fetal medicine. He has held academic appointments at Harvard Medical School, the University of South Florida, and Tufts University School of Medicine. His clinical roles have included maternal-fetal medicine attending positions at MetroWest Medical Center, Beth Israel Deaconess Medical Center, Boston Medical Center/St. Elizabeth’s and Tufts Medical Center. Urato received his bachelor’s degree from Harvard College and his medical degree from Harvard Medical School. He has also published extensively in peer-reviewed journals and participated in U.S. Food and Drug Administration advisory panels, according to HHS.

• Biss is an obstetrician and gynecologist in St. Petersburg, Florida. Biss has held multiple hospital leadership positions at Bayfront Health/Orlando Health Bayfront Hospital, including chief of staff, chairman of obstetrics and gynecology, and medical executive board officer. She is board-certified in obstetrics and gynecology and maintains membership in several professional medical associations. Biss received her medical degree from Tufts University School of Medicine. Her experience includes clinical education roles and publication of COVID-19 vaccine safety guidelines for pregnant women, according to HHS.

“President Trump asked us to bring the childhood immunization schedule in line with gold-standard science,” Deputy HHS Secretary Jim O’Neill said in a news release. O’Neill also is acting director of the U.S. Centers for Disease Control and Prevention. “ACIP is doing just that. Our new ACIP members have the clinical expertise to make decisions driven by evidence, not dogma.”

In 2023, Biss testified in a congressional hearing on COVID-19 vaccine harm sponsored by then-Rep. Marjorie Taylor Greene (R-Georgia). Paul Offit, M.D., a pediatrician and nationally known expert on vaccines, critiqued her testimony in his online blog. Urato has spoken publicly about potential ill health effects of selective serotonin reuptake inhibitor antidepressant drugs in pregnant women and developing babies.

They join the following ACIP members: chair Kirk Milhoan, MD, PhD; vice chair Robert W. Malone, M.D., M.S.; Hillary Blackburn, Pharm.D., MBA; Evelyn Griffin, M.D.; Joseph R. Hibbeln, M.D., ABNP, Capt. USPHS (Ret.); Retsef Levi, Ph.D.; H. Cody Meissner, M.D.; James V. Pagano, M.D., FACEP; Vicky Pebsworth, Ph.D., RN; Raymond Pollak, M.D., FACS, FRCS; and Catherine M. Stein, Ph.D.

Changing the schedule

Vaccines have become one of the most controversial issues in the tenure of Kennedy in the second term of President Donald J. Trump. On Jan. 5, the CDC announced O’Neill acted on the president’s memorandum to update the childhood immunization schedule. CDC revised the recommended childhood vaccinations from 17 immunizations for all children to 10 diseases for which there is international consensus, and varicella (chickenpox). “For other diseases, the CDC will recommend immunization for high-risk groups and populations, or through shared clinical decision-making when it is not possible for public health authorities to clearly define who will benefit from an immunization,” according to a CDC fact sheet said.

As for effects in the exam room, at least one survey found large numbers of adults in the U.S. are unsure what “shared decision-making” actually means when it comes to vaccines.

See CDC in court

AAP and the American Public Health Association recently announced their lawsuit to stop the ACIP meeting and vacate the CDC’s announced changes to childhood vaccine recommendations. Additional supporters include the American College of Physicians, the Society for Maternal-Fetal Medicine, the Massachusetts Public Health Alliance and the Infectious Diseases Society of America.

“Court intervention is now essential to prevent further harm, protect evidence-based recommendations, and ensure that critical decisions affecting children’s health are made transparently and guided by evidence, not ideology,” plaintiffs’ attorney Richard Hughes IV said in a statement.

“We are confident that we will demonstrate for the court that this administration has acted arbitrarily and capriciously in revisions to the childhood immunization schedule and, furthermore, that the current ACIP will continue this destructive pattern if allowed to continue meeting,” Hughes said. “The integrity of the vaccine policymaking process is not a technical detail: it’s what maintains public trust in vaccination and protects communities across the country.”

The medical groups stated that a hearing on the case is scheduled in federal court on Feb. 13.

States seek guidance from physicians

Regardless of court action, at least 17 states have announced they will opt for vaccine guidance from AAP, not CDC, according to a report from the Center for Infectious Disease Research & Policy (CIDRAP) at the University of Minnesota. The states are: California, Colorado, Connecticut, Hawaii, Illinois, Maryland, Massachusetts, Minnesota, New Hampshire, New Jersey, New York, North Carolina, Oregon, Pennsylvania, Vermont, Washington and Wisconsin. CIDRAP noted that California and Illinois have passed laws allowing the states to follow vaccine advice of independent medical organizations, and Maryland lawmakers are considering a similar bill.