Who should get COVID shots this fall? And should all babies get vaccinated against hepatitis B at birth?
These are two of the questions that an influential federal vaccine advisory group, the Advisory Committee on Immunization Practices, is set to address in a meeting Thursday and Friday at the Centers for Disease Control and Prevention in Atlanta. The panel provides guidance to the CDC director on how vaccines should be used to prevent disease in the U.S. population.
Their recommendations determine which vaccines are offered for free through the Vaccines for Children program, and what many health insurers must cover. They also influence state and local laws on vaccine requirements.
Many health and medical experts are watching closely — and with concern — given that Health Secretary Robert F. Kennedy Jr. has stacked the panel with members who question the safety of long-established vaccines and has made statements critical of current vaccine policy, saying it has eroded public trust.
Ousted CDC director Susan Monarez who served in the position for 29 days before being fired by Kennedy in late August testified at a congressional hearing Wednesday that Kennedy had pressured her to agree in advance to the committee's recommendations. She said he told her the childhood vaccine schedule "would be changing starting in September, and I needed to be on board with it."
She also stated there's "real risk that recommendations could be made restricting access to vaccines for children and others in need without rigorous scientific review."
Kennedy has also removed or pushed out many of the career CDC staff that support the committee and barred professional medical groups such as the American Academy of Pediatrics and the American Medical Association from serving in their traditional roles as expert liaisons to the advisory committee.
Here are three things to watch for:
1. COVID vaccine access could be cleared up, or narrowed
The committee is coming late to COVID vaccines this year. The Food and Drug Administration approved the fall boosters two weeks ago – saying those who are 65 and up, or have high risk medical conditions are eligible. Shots have already arrived in some drugstores and doctor's offices.
Given the lag between the FDA approval and a CDC recommendation, there's been uncertainty about who should get the vaccines and access differs from state to state.
But health experts worry that when the group votes, they could recommend limits that would make it harder for people to get COVID shots this fall.
"People are still being hospitalized. People are still dying. The numbers are smaller, thankfully, but that doesn't mean that they're gone," says Dr. Yvonne Maldonado, a professor of pediatrics at Stanford Medicine Children's Health and one of the previous ACIP members Kennedy fired, "If we can prevent a hospitalization or death, we should allow people to make that choice and do that."
The panel includes people who say that COVID vaccines have harmed or killed many, even if that doesn't square with the evidence.
"The idea that there have been dozens of deaths or other unacknowledged harms that were swept under the rug doesn't align with what we saw during the COVID pandemic, regarding the careful ongoing scrutiny of the vaccines throughout their introduction," says Jason Schwartz, associate professor of health policy at the Yale School of Public Health.
2. Hepatitis B vaccine may no longer be recommended for infants
Hepatitis B, a viral infection that attacks the liver, cannot be cured. And the hepatitis B virus – more transmissible than HIV and capable of cloaking itself from the immune system – can stay hidden in the body for years. A series of shots starting just after birth can prevent the viral infection that causes liver disease and cancer down the line.
But at the ACIP meeting in June, committee chair Martin Kulldorff questioned the need for all babies to receive the vaccine. "Unless the mother is hepatitis B positive, an argument could be made to delay the vaccine for this infection, which is primarily spread by sexual activity and intravenous drug use," he said.
Screening expectant mothers for hepatitis B has long been recommended, Dr. Rochelle Walensky, former CDC director in the Biden administration, said at a gathering of health journalists this month. But history shows "that was not foolproof," she said. "That failed our children." Before the universal vaccine recommendation in 1991, thousands of children were being infected every year.
Since then, cases of acute hepatitis B have plummeted – from over 20,000 cases a year, to fewer than 1,000. "We saw this blanket protection that protected an entire generation of kids, so that as they got older and they had exposures and risks, they didn't get hepatitis B," says Dr. Su Wang, an internist and researcher specializing in hepatitis at Cooperman Barnabas Medical Center in New Jersey.
Advocates had expected that vaccines would continue to protect younger generations, and turned their efforts to gaps in diagnosis and treatment in older people, in an effort to eliminate hepatitis B by 2030. "This is a goal that is doable, because we have all the tools," Wang says.
At Wednesday's hearing with Monarez, Sen. Bill Cassidy, R-La., made a strong plea for keeping the recommendation that infants get the shots. Cassidy, who was a practicing hepatologist for more than 20 years before entering politics, noted that the current recommendation "is not a mandate" but gives parents the choice to get the vaccine for their infant and have it paid for.
"There are people who would otherwise be dead if those parents weren't given the option to have their child vaccinated," he said.
3. Age limit for childhood MMRV vaccine could change
In the June ACIP meeting, chair Martin Kulldorff gave a presentation suggesting that the combination vaccine for measles, mumps, rubella and varicella (or chickenpox) should not be given to children under 4 years old.
The combination vaccine has a slightly higher risk of causing fevers that can lead to seizures in children under two years old, compared with the MMR and varicella vaccines separately.
These febrile seizures are temporary, says Dr. Lakshmi Panagiotakopoulos, a pediatrician and former co-lead of ACIP's COVID-19 vaccine workgroup. "They're not life threatening. Most don't go on to have any other complications," she says.
Data from the CDC's vaccine safety surveillance system shows that no such problems were found in children over age 4.
In fact, the CDC in 2009 recommended giving the first doses of the measles and chickenpox vaccines separately to young children, though parents can choose to get the combination vaccine if they want. Some parents may find this more convenient than having to come back again for a separate shot.
Recommending against the vaccine for children under age 4 would limit access to a safe way to prevent serious illness in kids, says Panagiotakopoulos. "We've studied all this, so much and so in-depth," she says of the CDC's vaccine staff.
When this committee stops recommending a vaccine, insurers are no longer required by federal law to cover it. That could make a vaccine much more expensive and less available.
And while Kennedy has charged the panel with restoring public trust, public health experts worry that relitigating past vaccine policies, in the absence of new science or safety concerns, has the opposite effect. "It's decreasing vaccine coverage, decreasing vaccine confidence, decreasing confidence in medical professionals and in science in general," Panagiotakopoulos says.
It could lead to less healthy communities and more people dying from preventable diseases. "It will not happen overnight, but it will start to erode the ability that we have to prevent completely preventable diseases in our young children," says Maldonado, "That is going to be a tragedy and will be very hard to reverse."
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