Vaccine advisers for the Centers for Disease Control and Prevention are expected this week to consider softening or eliminating recommendations for some routine childhood immunizations — which doctors say could significantly depress vaccination rates and trigger more infectious disease outbreaks.
Any decisions by the Advisory Committee on Immunization Practices — now mainly composed of members who share Health Secretary Robert F. Kennedy’s vaccine skepticism — will be closely scrutinized, given dramatic events at the Department of Health and Human Services and in Congress in recent weeks.
At a Senate Finance Committee hearing earlier this month, Democrats and some Republicans grilled Kennedy about his vaccine policy decisions. The interrogation followed the uproar just days before over Kennedy’s ouster of former CDC Director Susan Monarez, who said she refused a request that she rubber stamp vaccine recommendations — a charge Kennedy denies.
Monarez is now expected to testify under oath about her firing before the Senate Committee on Health, Education, Labor and Pensions on the eve of the advisory committee meeting, which is scheduled for Sept. 18-19.
Richard Besser, CEO of the Robert Wood Johnson Foundation and a former acting CDC director when Barack Obama was president, noted that the panel’s meeting was announced in the Federal Register the day after Monarez's removal.
He and other public health experts and vaccine advocates told POLITICO that if ACIP chooses to weaken recommendations, it could further confuse Americans, help normalize policy decisions not grounded in science and amount to yet another blow against the U.S. public health system.
“I have real concerns that they will use the ACIP process as a way of driving forward an ideology, regardless of science and evidence,” Besser said, adding that Kennedy “is quite swiftly moving forward with dismantling our vaccination system, and that gives me great concern.”
HHS spokesperson Andrew Nixon said any changes to vaccine recommendations will be made “transparently” and based on evidence.
“These concerns are baseless,” he said in an email. “We are restoring the doctor-patient relationship.”
The external advisory panel’s recommendations, which are usually adopted by the CDC, also have influence that goes well beyond individual access. States typically use them as the basis for their school-entry immunization mandates. They determine whether insurance must pay for the shots and whether doctors and pharmacists can be held liable for administering them in certain cases.
The panel — which was reconstituted in June after Kennedy fired all 17 members — will discuss the Covid-19, hepatitis B and the measles, mumps, rubella and varicella (MMRV) vaccines, as well as the respiratory syncytial virus (RSV) shot and may take recommendation votes. It’s also possible that the entire childhood vaccine schedule, with 16 immunizations, could be upended.
Here is the discussion about each in recent months:
Hepatitis B and MMRV vaccines targeted
Kennedy and his allies have suggested these two mainstays of the childhood vaccine schedule shouldn’t be widely used by questioning their safety — or, in the case of hepatitis B, dismissing the risk of young children contracting the disease.
Routine use of the hepatitis B vaccine, which is recommended for all newborns within the first 24 hours of life, has been criticized by Make America Healthy Again influencers and anti-vaccine activists close to Kennedy for years.
MAHA influencers like ACIP member Robert Malone and Casey Means, President Donald Trump's latest pick to serve as surgeon general, have questioned the necessity of the universal recommendation. They argue that hepatitis B is a disease contracted through high-risk behaviors, so infants shouldn’t receive the shots.
Hepatitis B is extremely infectious and can be spread through sex, intravenous drug use and from mother to baby during childbirth. But it’s also easily transmitted through casual contact with infected blood or saliva. Infections, which can eventually cause cirrhosis and cancer, have a 95 percent chance of becoming chronic if acquired at birth unless infants are vaccinated within 24 hours.
The vaccine advisory panel first recommended the hepatitis B vaccine be given to newborns in the hospital in 1991 after a focus on identifying high-risk populations like drug users, health care workers and people with multiple sexual partners failed to control the disease’s spread. More than a quarter of hepatitis B cases have no identifiable risk behavior or exposure, according to the CDC. Universal infant vaccination led to a 99 percent drop in infection rates over 20 years.
Disagreement over the newborn vaccine spilled over into the Senate GOP caucus before Kennedy’s testimony this month before the Finance Committee.
The social media spat on X between Sens. Rand Paul of Kentucky and Bill Cassidy of Louisiana erupted after Paul, an ophthalmologist, panned proponents of universal hepatitis B vaccination as “simply schilling for Big Pharma.” Rather than vaccinate newborns, he asserted, expectant mothers can be tested for the virus to ensure they don’t pass it to their babies during birth.
Cassidy pushed back, posting that, based on his experience as a liver disease specialist in Louisiana, “many patients” who are pregnant are not tested, often because of the lack of prenatal care.
“It could have been prevented by a proven safe and effective vaccine,” Cassidy said.
ACIP Chair Martin Kulldorff said at the group’s June meeting that it also may consider advising against use of a product that combines the measles, mumps and rubella (MMR) vaccine and chickenpox vaccine into one shot for children under 4.
Under the current vaccine schedule, the CDC recommends that children receive two doses each of the MMR vaccine and the varicella vaccine — the first between 12 and 15 months and the second between 4 and 6 years of age. A combination vaccine, known as MMRV, may be used, but the agency advises that the first dose be administered as two separate shots due to an increased risk of febrile seizures in kids under 2.
Fever-induced seizures are common in young children — the CDC estimates the risk at 5 percent — but don’t cause permanent harm. MMRV “may be used if parents or caregivers express a preference,” the schedule states. Proponents of the combined vaccines argue that they allow parents to use their discretion if, for example, the child reacts especially poorly to shots.
“Up to this point, the decision has been, let the parent decide,” said Dr. Paul Offit, a former federal vaccine adviser and director of the Children's Hospital of Philadelphia's Vaccine Education Center.
“I think they're about to take that decision away,” he added.
Covid, RSV recommendations
The FDA-approved labels for the three Covid vaccines available in the U.S. this fall specify that they’re indicated for people 65 and older and for younger individuals with at least one underlying condition putting them at high risk for serious illness.
The CDC panel could vote to recommend the Covid vaccines’ use as spelled out on their labels, effectively endorsing the FDA’s actions to tailor their administration. However, it could go further to limit their use, given many of the members’ hostility to mRNA vaccines.
The Washington Post reported Friday that Trump health officials plan to connect the Covid vaccines to 25 deaths of children in a presentation to ACIP. The assertion is expected to be based on reports submitted to the FDA’s Vaccine Adverse Event Reporting System, or VAERS, which collects unverified side effects from vaccines. The database doesn’t prove causality — anyone can submit information to the system — and federal agencies use the reports to investigate potential safety signals from shots.
A former federal official granted anonymity to speak candidly told POLITICO that pediatric deaths in VAERS were evaluated in prior years by staff who examined medical records and autopsy reports. None were determined to be connected to an mRNA vaccine, they said.
Malone has already suggested in recent interviews that data will be presented regarding the risk of death from the shots.
“Kids have died from the Covid vaccine,” FDA Commissioner Marty Makary said in a podcast interview last week.
A few deaths attributed to mRNA Covid vaccines have been reported in other countries, but none in the U.S. appear to have been definitively linked to date.
The new FDA labels are already causing confusion as providers question whether they’ll be adequately shielded from liability if they vaccinate patients, who in turn must grapple with new eligibility parameters. Pharmacists in some states are declining to offer Covid shots until ACIP votes on recommendations, and other providers are directing people to obtain prescriptions before receiving them.
Kennedy and Makary have insisted that “anybody” who wants a Covid vaccine can get one, despite several reports — and lawmaker statements — describing obstacles.
Amy Pisani, CEO of Vaccinate Your Family, an advocacy group, said the Trump officials’ statements assume that most Americans have a primary care doctor they can turn to for a shot or prescription when an estimated third of the population lacks one.
“If you don’t have a doctor, you don’t have access to a vaccine because a pharmacy’s not going to give it to you,” she said of the Covid vaccine.
RSV — a common virus that produces mild cold-like symptoms in most healthy people but can cause serious illness in babies and older adults — is also on the agenda. RSV is the leading cause of infant hospitalizations, according to the CDC, and about 80 percent have no underlying health conditions. The agency estimates the virus kills 100 to 300 children under 5 annually.
The FDA approved the first RSV vaccine for pregnant women and the first single-dose monoclonal antibody for infants in 2023, breakthroughs the CDC has said reduced hospitalizations in the 2024-2025 viral season. A second RSV shot for infants was approved earlier this year.
While it’s unclear which product will be ACIP’s focus, Malone has suggested that he was duped by a research presentation at the committee’s June meeting into backing a universal recommendation for the new RSV antibody shot for babies.
At the same meeting, ACIP member and Dartmouth pediatrician Dr. Cody Meissner, touted the shot’s safety and said he “would strongly recommend” either the antibody or the vaccine for RSV protection.
More possible changes
In addition to the known agenda items, ACIP members have said they plan to investigate the broader childhood vaccine schedule, which recommends 16 immunizations ranging from the four-dose polio series beginning in infancy to annual flu shots through 18 years of age.
While the CDC issues the document, the committee advises the agency on which shots to include and how strongly they should be recommended, and the list informs school-entry mandates set by states.
Malone, who’s suggested some of those shots are unsafe, said this month that changes to the document are “certainly … on the table.” A group of vaccine-skeptical doctors and advocates sued the CDC in August, asking a federal court to reclassify nearly all vaccines on the schedule to “shared clinical decision-making” until the CDC “completes scientifically rigorous studies” demonstrating the current schedule’s safety. That category, below “routine,” is based on individual considerations with no default decision to vaccinate — and could affect school mandates in states that explicitly link their vaccine policies to ACIP recommendations.
Leah Wilson, executive director of co-plaintiff Stand for Health Freedom, suggested Wednesday during a call of the Kennedy-aligned advocacy group MAHA Action that the challenge could spur a settlement with the government. The agency must respond to the filing by mid-October.
“We hope more than anything that this CDC lawsuit is a short-term play … because with the current ACIP and Bobby’s reform of the agency, this is ripe for review,” she said. The group has organized an effort to get public comments supporting the arguments from their challenge onto the ACIP’s meeting docket.
The ACIP-access connection
The 2010 Affordable Care Act and the 2022 Inflation Reduction Act require most health insurers and public programs to cover ACIP-recommended vaccines that the CDC director has endorsed with no cost-sharing.
A 1993 law creating the federal Vaccines for Children program for Medicaid-eligible and un- or underinsured kids specifies that it covers all shots the ACIP recommends for the childhood schedule. This makes the safety-net program, which covers about half of American children, especially vulnerable to policy changes.
“With a secretary who is not supportive of many routine vaccinations, it means that parents that decide to vaccinate their children may have to pay out of pocket,” Besser said. “And for most people in America, that’s a barrier that just can’t be overcome.”
Any changes to current vaccine recommendations would disproportionately affect low-income communities with poor access to health care, said Dr. Tyler Evans, an infectious disease specialist who was slated to join ACIP this year before its overhaul.
“It just increases that polarization of the haves and the have-nots,” he said.
Despite Kennedy’s vehement rebuttals, lawmakers at the Senate Finance Finance hearing repeatedly raised concerns that vaccines Americans have long taken for granted will no longer be readily available.
“All these vaccines that we’re talking about today are free and accessible to parents today in America who have the freedom to be able to make that choice for their children,” Sen. Michael Bennet (D-Colo.) said Thursday. “Will that be true after your handpicked panel makes their judgments about these vaccines?”
David Lim contributed to this report.
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