New CDC advisors will review existing vaccine recommendations

Key takeaways:

• An ACIP work group will revisit existing vaccine recommendations, worrying experts.
• The AAP said it will no longer participate in ACIP meetings.
• A vote on RSV immunizations was postponed until Thursday.

The chair of the CDC’s newly remade vaccine advisory committee said Wednesday that the committee will be reviewing existing vaccine recommendations and assessing whether people receive too many shots, raising concern among experts.

Martin Kulldorff, PhD, formerly a professor of medicine at Harvard Medical School and Brigham and Women’s Hospital in Boston, delivered opening remarks at the first meeting of the Advisory Committee on Immunization Practices since HHS Secretary Robert F. Kennedy Jr. fired all 17 members of the federal panel and replaced them with his own selections.

Kulldorff said an ACIP work group will be formed to reevaluate vaccines that have not been reviewed by the committee for 7 years and assess the “cumulative effect” of vaccines, which aligns with concerns commonly voiced by anti-vaccine advocates. ACIP work groups review evidence and help develop vaccine recommendations that are voted on by ACIP members.

“In the first 30 minutes of the meeting, it was clear to me that there was a clear intent to really do damage to our country’s vaccine program,” Sean T. O’Leary, MD, MPH, chair of the American Academy of Pediatrics’ committee on infectious diseases, told reporters.

Only seven of Kennedy’s eight picks for the ACIP attended the meeting, which ran behind all day and ended without a scheduled vote on respiratory syncytial virus immunization. The vote will happen on day 2 of the meeting Thursday.

Senator Bill Cassidy, MD, a Republican from Louisiana, said during a confirmation hearing for CDC director on Wednesday that Michael A. Ross, MD, an obstetrician and gynecologist, withdrew from the committee because of an “apparent financial conflict of interest.”

During the daylong meeting, ACIP members listened to long presentations on COVID-19 vaccine uptake and safety and RSV immunization for infants and pregnant women.

‘Gravely concerned’

Kulldorff specifically mentioned that the ACIP would revisit recommendations made for vaccines against measles and hepatitis B virus. The committee is already planning to discuss a combination vaccine that protects against measles, mumps, rubella and varicella (MMRV) during the second day of the meeting. Kulldorff is scheduled as the presenter for that discussion, which will address MMRV use among children aged younger than 4 years, according to the posted agenda.

In his remarks, Kulldorf cast doubt on the necessity of vaccinating infants against HBV at birth if the mother has not tested positive for the virus. That contradicts existing guidance, including from the CDC, which recommends that all newborns get a first dose of HBV vaccine at birth regardless of their mother’s infection status. The second and third doses should be administered at age 1 to 2 months and 6 to 18 months, respectively, according to the CDC vaccine schedule.

HBV vaccines have been proven to be effective, and evidence “overwhelmingly” shows that they are also safe, according to the CDC.

O’Leary called the HBV birth dose “one of the cornerstones of our hepatitis B prevention policy.” He said a child infected at birth has a 90% chance of developing chronic active HBV, and that 25% of those children will die of the disease.

In a statement sent to Healio, the Hepatitis B Foundation said it was “gravely concerned” that revisiting the recommendation that all newborns get vaccinated against HBV “will lead to [the recommendation’s] eventual elimination.”

“We are disturbed by the tone and implied bias in ACIP’s announcement to study universal hepatitis B birth dose. The question posed today, ‘Is it wise to administer the hepatitis B vaccine to newborns before they leave the hospital?,’ is inherently biased against the vaccine and is not an acceptable scientific research question,” the foundation said. “The stated question imposes doubt, is partial, and falsely implies that the hepatitis B birth dose is unsafe for babies while decades of research and implementation have shown that the birth dose is both safe and effective.”

The committee will review COVID-19 vaccine recommendations as well. H. Cody Meissner, MD, a professor of pediatrics at Dartmouth College Geisel School of Medicine and a member of the Healio Pediatrics Peer Perspective Board, said vaccination rates among children and people older than 75 are “disappointingly low,” and questioned whether uptake should be taken into consideration in ACIP’s recommendations.

“That fact that it is so low is a reflection of the lack of trust that parents have with the COVID-19 recommendations that ACIP has been giving,” Kulldorff responded.

The CDC recently tweaked its COVID-19 vaccine recommendations for kids to switch to a shared decision-making model, rather than recommending that children “should receive” a vaccine. The change was announced by Kennedy without the input of the ACIP, which would normally be tasked with making that kind of recommendation to for their approval.

Although vaccines with shared decision-making recommendations are supposed to be covered by insurance, O’Leary said he is worried about how the change will impact accessibility through the Vaccines for Children (VFC) program, which provides free immunizations to children whose families are unable to pay for them. Nearly half of U.S. children qualify for the program.

“If you participate in the Vaccines for Children program, you are required to stock both the VFC product, as well as the private stock product,” O’Leary said during a media briefing. “That is not true under shared decision-making.”

He said if providers are no longer required to stock certain vaccines, it could make them inaccessible to kids — not just COVID-19 vaccines, but any other vaccines that may move to a shared decision-making model.

AHIP, a trade association representing health insurance companies in the U.S., released a statement Wednesday affirming its commitment to maintaining coverage for immunizations.

“As we navigate an evolving health care landscape, maintaining robust immunization coverage continues to be a top priority for protecting both individual and community health,” the statement said. “We are committed to ongoing coverage of vaccines to ensure access and affordability for this respiratory virus season.”

AAP withdraws from ACIP

The AAP, one of the many medical associations traditionally represented at ACIP meetings, confirmed in a press release Wednesday that it did not send a liaison to the meeting.

“For decades, the AAP and other organizations have worked to shape immunization policy through the ACIP,” AAP President Susan Kressly, MD, said in a video posted on X. “But now, with the committee dismissals, it is no longer a credible process. We won’t lend our name or our expertise to a system that is being politicized at the expense of children’s health.”

While abstaining from participating in ACIP meetings, Kressly said that AAP will continue to publish its own immunization schedule.

“For the first 30 years of ACIP’s existence, they often deferred to AAP for the childhood immunization schedule, and we have been harmonized since 1995,” O’Leary said. “This is a really sad day, because we can no longer really endorse what is going on right now with ACIP.”

Postponed vote

The committee’s action item for the day was to vote on a proposed recommendation for clesrovimab, a monoclonal antibody approved by the FDA earlier this month for the prevention of RSV disease in infants.

Currently available options to protect infants from severe RSV disease include a maternal vaccine and nirsevimab, a monoclonal antibody. As Healio previously reported, a majority of infants born in the U.S. during the 2023-2024 RSV season — the first year these options were available — were immunized against RSV. In addition, CDC representatives presented data from the 2024-2025 season that showed RSV hospitalizations fell 28% to 43% among infants aged 0 to 7 months, compared with pooled rates from 2018 to 2020.

“People need to understand what a spectacular accomplishment these results are,” Meissner said. “RSV is the most common diagnosis among children who are hospitalized in the first 12 months of life.”

The committee will vote Thursday on a proposed recommendation that infants younger than age 8 months who are born during or entering their first RSV season and who are not protected through maternal vaccination should receive one dose of clesrovimab. They will also vote on adding clesrovimab to the VFC program. Unlike nirsevimab, high-risk infants entering their second RSV season will not be eligible to receive clesrovimab.

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