Kennedy's vaccine advisory panel to vote on COVID-19, hepatitis B and chickenpox recommendations

A federal vaccine advisory committee led by Health Secretary Robert F. Kennedy Jr. is set to vote this week on possible changes to recommendations for COVID-19, hepatitis B and chickenpox vaccines, a move that public health experts say could raise new questions among parents and, if paired with coverage changes, restrict access to shots for low-income children.

The Advisory Committee on Immunization Practices (ACIP) will meet Thursday and Friday in Atlanta, according to an agenda posted this week. The exact questions the committee will vote on have not been made clear, and officials at the Department of Health and Human Services did not immediately respond to requests for details. HHS on Monday announced five additional appointments to the panel, bringing the roster to 12 members.

ACIP makes formal recommendations to the director of the Centers for Disease Control and Prevention on how already approved vaccines should be used. CDC directors have typically accepted ACIP recommendations, which inform clinical practice and vaccination programs across the country. Kennedy, a long-time vaccine critic before becoming the nation's top health official, dismissed the previous 17-member committee earlier this year and replaced it with a panel that includes voices who have publicly questioned vaccine safety.

Public health specialists expressed concern that votes this week could do more than prompt discussion: they could change whether certain vaccines are covered by the federal Vaccines For Children (VFC) program, which pays for shots for families lacking money or adequate insurance and accounts for roughly half of childhood vaccinations in the United States each year.

"I'm tightening my seat belt," said Dr. William Schaffner, a vaccines expert at Vanderbilt University, describing the anxiety among clinicians about the implications of the committee's work. Dr. Sean O'Leary of the American Academy of Pediatrics said that if ACIP follows recent federal regulatory language narrowing the use of this season's COVID-19 shots for younger children, and the CDC issues no clarifying guidance, access could be lost for about half of U.S. children.

The three vaccines on the agenda each carry distinct histories and stakes.

The committee's deliberations on COVID-19 shots come after a contentious spring in which Kennedy announced he was removing COVID-19 vaccines from CDC recommendations for healthy children and pregnant women. That announcement drew criticism from medical groups and public health organizations and prompted a lawsuit from the American Academy of Pediatrics and other groups. CDC officials subsequently clarified that families could still obtain the 2024-2025 COVID-19 vaccine for children in consultation with clinicians, which preserved coverage through the VFC program. However, the committee has not yet voted on whether to recommend this fall's COVID-19 formulation or whether it should remain covered by VFC.

The issue was complicated further when the Food and Drug Administration last month licensed this season's COVID-19 vaccines with narrower indications for healthy younger adults and children than in prior years. If ACIP endorses such limits without additional CDC clarification, pediatricians warn that access for many children could be curtailed. The American Academy of Pediatrics has urged continued vaccination for children 6 months and older.

Hepatitis B vaccination for newborns was first broadly recommended in the United States in 2005, when ACIP advised a dose within 24 hours of birth for medically stable infants weighing at least 4.4 pounds (2 kilograms). The shot dramatically reduces the risk that infants born to infected mothers will develop chronic hepatitis B, which can lead to serious liver disease. Studies show newborn vaccination is 85% to 95% effective in preventing chronic infections, and experts say there is no recent, peer-reviewed evidence of safety problems from administering the vaccine on the first day of life.

Yet members of the reconstituted panel signaled in June that they wanted to revisit the guidance. Schaffner and other infectious disease clinicians note that prenatal screening for hepatitis B was intended to identify infected mothers, but screening misses some cases, leaving infant vaccination as a critical backstop against mother-to-child transmission.

Chickenpox, or varicella, was declared a routine childhood vaccine in 1995 and sharply reduced cases and deaths. A combination measles-mumps-rubella-varicella (MMRV) vaccine was licensed in 2005, and early ACIP guidance initially favored the combination over separate injections. Studies later showed that children given the combination vaccine were more likely to experience fever, rash and, rarely, seizures after vaccination than those given separate MMR and varicella injections. In 2009, ACIP removed its earlier preference and said either the combination or separate shots were acceptable for the first dose. Most pediatricians now typically give separate doses for the first shot and use the combination for the second dose.

ACIP members have suggested revisiting varicella recommendations despite no new peer-reviewed evidence of harm from the combined vaccine, prompting sharp criticism from pediatric organizations. "This version of the ACIP is an orchestrated effort to sow distrust in vaccines," O'Leary said.

HHS's five newest appointees to ACIP include Hillary Blackburn, a pharmacist who is described by HHS as director of medication access and affordability for AscensionRx; Dr. Evelyn Griffin, an obstetrician-gynecologist in Baton Rouge, Louisiana; Dr. Kirk Milhoan, a pediatric cardiologist who co-runs a medical missionary organization and who previously testified to Congress attributing increases in cardiovascular disease in older teens and young adults to vaccines; Dr. Raymond Pollak, a transplant specialist in Skokie, Illinois; and Catherine Stein, a disease researcher from Case Western Reserve University who during the pandemic worked with an Ohio group that questioned COVID-19 case counts and severity.

The decisions expected from ACIP this week will carry practical consequences because CDC leadership has historically followed the committee's guidance, and such recommendations influence clinical practice and the scope of federally funded vaccine programs. Public health leaders say clarity — particularly about whether vaccines will remain part of the VFC program — will be critical to ensuring continued access for children and confidence among parents and health care providers.

The committee's Thursday-Friday meeting in Atlanta is open to the public and will be livestreamed, according to the posted agenda, though HHS provided few additional details about the specific motions and language that will be put to a vote.