Kennedy’s handpicked CDC advisers to weigh major change to childhood vaccine schedule
By Jamie Gumbrecht, Brenda Goodman, John Bonifield, CNN
(CNN) — Vaccine advisers to the US Centers for Disease Control and Prevention may vote this week to make a major change to the childhood vaccine schedule, potentially delaying a dose of the hepatitis B vaccine given to newborns by weeks or even years.
The members of the Advisory Committee on Immunization Practices were handpicked by US Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist, after he abruptly fired the 17 sitting members this year. The agenda for this week’s meeting offers few details beyond discussion and a vote about hepatitis B vaccines, and more discussion on ingredients and timing for vaccines on the childhood schedule. Reference documents and voting language typically posted ahead of meetings have not yet been made available.
But in previous meetings and public comments, some committee members have pushed for changes to the hepatitis B vaccine schedule and questioned long-tested vaccine ingredients. Infectious disease and public health experts warn that such moves will sow fresh doubt about the well-established safety and effectiveness of vaccines, and lead to a patchwork of policies from place to place that ultimately limit access.
“The truth of the matter is, we know vaccines have saved lives. They are saving lives actively,” Dr. Raynard Washington, director of Mecklenburg County Public Health in North Carolina and head of the Big Cities Health Coalition, said Tuesday ahead of the CDC advisers’ meeting. “They’re saving costs for our community, both in terms of financial cost — health care costs, health care resources — and expense on individuals’ lives.”
ACIP’s recommendations shape doctors’ guidance to patients as well as state vaccine policy, insurance coverage and the Vaccines for Children program. The committee’s processes and priorities have already shifted: In June, the panel endorsed thimerosal-free vaccines, although there’s no evidence of harm from the vaccine preservative. In September, it recommended splitting up the combined measles, mumps, rubella and chickenpox vaccine and announced plans to investigate long-settled vaccine science.
The newly appointed committee has seen shifts in its membership, too. This week, HHS announced that Dr. Martin Kulldorff, the committee’s recent chair, has left to take a new role within the agency. Dr. Kirk Milhoan, a cardiologist who has criticized the Covid-19 vaccine, will take over as the new chair.
The moves come just after a top US Food and Drug Administration official said in an internal memo that the agency will adopt a new approval process for vaccines to require more evidence of their safety and value before they can be marketed.
Ahead of Thursday’s vote, it’s not clear what evidence is driving the CDC vaccine committee’s plans for hepatitis B vaccines.
The risks from the disease are significant: Viral infection can hide in the body for years, until it leads to liver failure, cirrhosis or cancer. No new studies have revealed safety concerns about the hepatitis B vaccine, but there has been a dramatic decline in cases among infants since 1991, when the CDC recommended universal vaccination for babies. Reported hepatitis B infections in infants plummeted from an estimated 18,000 cases every year to about 20 per year.
Still, anti-vaccine activists have long questioned the need for the birth dose of the vaccine, since hepatitis B is mainly transmitted through dirty drug needles or sexual activity.
“Why would you give that to a 1-day-old child?” Kennedy asked in a June town hall. “It’s really a profit motive.”
Infectious disease experts say the sharp drop in case numbers show that the strategy works. It created a safety net for babies at risk from pregnant mothers or other family members who may not know they have the virus, and saved them from a life of tough treatments and constant dread of spreading the disease.
“I understand that babies, of course, are precious and appear to be quite vulnerable, but they’re also vulnerable to hepatitis B,” said Dr. Anthony Fiore, an infectious diseases physician and former CDC official.
“You have this opportunity to prevent a disease very easily that has very serious long-term consequences. There’s kind of no going back.”
Easy to catch, impossible to cure
When he was 16, John Ellis Jr. went to the doctor with severe stomach pain. He was expecting to be sent home with Tums and advice to eat healthier, but blood tests revealed a terrifying surprise: chronic hepatitis B.
Ellis and his mom, a nurse, thought it was a mistake. There are highly effective vaccines — he’d gotten a dose in middle school — and they didn’t know anyone with hepatitis B.
But Ellis was born in 1990, just before the hepatitis B birth dose became standard.
Before 1991, mothers were recommended to be tested for hepatitis B during pregnancy so their babies could be vaccinated shortly after birth, if needed — a strategy the current CDC vaccine advisers recommended at their last meeting. But tests were often lost or results were jumbled. Many patients weren’t tested at all. Even if a mother wasn’t infected, unvaccinated babies had no protection from other relatives, caregivers or peers who could spread the disease.
There is no way to know how Ellis became infected. Based on the scarring on his liver, his doctors estimated that it happened when he was 3 or 4. It could have been at day care, school or the dentist’s office.
What he knew at 16 was that his life was over.
“I thought that I was not going to survive it,” said Ellis, who’s now 35 and lives in his hometown of Pensacola, Florida.
Adults who are infected with hepatitis B usually clear it with no lasting effects. For kids, it’s different. About 90% of babies who are infected will carry the virus for life, and all the risks of organ failure, liver scarring or cancer.
A new modeling study, released as a preprint ahead of this week’s ACIP meeting, suggests that delaying babies’ hepatitis B vaccines for even a few months will drive up infections, long-term health complications and deaths. The researchers behind the analysis, which has not been peer-reviewed or published in a medical journal, had previously developed hepatitis B vaccination models to inform ACIP decisions. So far, they say they haven’t heard from the committee about their new research.
The new study found that delaying the birth dose to 2 months for babies whose mothers are not known to have hepatitis B — either because they tested negative or because their results are unknown — could lead to at least 1,400 preventable infections among children and 480 deaths for each year the delay is in place. Delaying the dose for 12 years could surge preventable infections to 2,700 and deaths to nearly 800 for each year of the recommendation.
Even if there was “perfect adherence” to vaccine recommendations, a 2-month delay among children whose parents tested negative for hepatitis B would lead to 90 acute infections, 75 chronic infections and 29 deaths for every year of the policy. Delaying it by 12 years pushes those numbers even higher.
Any delays would drive up health care costs by tens or hundreds of millions of dollars every year, the study found.
“When it turns into a chronic disease, it does not have a cure, and so infections that progress to a chronic condition end up needing, potentially, a lot of medical management and care and monitoring throughout life,” said Dr. Eric Hall, lead author of the study and an assistant professor at Oregon Health & Science University.
“My hope is that the committee understands that universal infant vaccination has been the cornerstone of hepatitis B elimination efforts” for decades, Hall said. “We’ve made a lot of good progress towards that, and it’s important that we don’t undo that important progress now.”
Finding hope in community
Ellis’ diagnosis landed him with a liver biopsy, medication and regular visits to the doctor. He learned that hepatitis B didn’t mean his life was over. He began to exercise and ride his bike. Rather than hiding his condition, he wondered, what if he was radically open about it?
At 17, he organized a 1,200-mile bike ride from Pensacola to Philadelphia, where the Hepatitis B Foundation is based. He rode with his best friend and his grandma in a chase car. His high school principal spoke at their sendoff. They biked about 60 miles every day for weeks, and for the last stretch — just as Ellis turned 18 — they were joined by Dr. Baruch Blumberg, the Nobel Prize-winning doctor who had discovered the hepatitis B virus and developed the vaccine against it.
Ellis said it was “a full-circle moment.” He can see how science was helping him and others, and how his mom, friends and community surrounded him and showed what it meant to live with hepatitis B. Nearly two decades later, it’s still fresh in his mind.
But, Ellis said, his experience is not typical. He knows other hepatitis B patients whose families dismissed them. It can feel impossible to explain to friends or potential romantic partners.
He said some of the rhetoric from the federal government paints everyone with hepatitis B as drug users or people with risky sexual behaviors, as if it makes it OK to “other” them. As if the disease could never hit that close to home.
“We’re people that got exposed. We didn’t ask for it,” Ellis said.
“I’m like anybody else. I’m trying to live a full life and be as unburdened by my condition as I can.”
So far, he’s been fortunate. He owns his real estate business in his hometown and has lifelong friends. His viral load is low, and he’s generally healthy. But he wonders how long it will last. There’s a reason hepatitis B is called “the silent killer,” he said.
Parents can make their own vaccine decisions for their babies, he said, and they should be empowered with information, including the realities of the risks of hepatitis B.
“If we’re making it harder for people who do choose to vaccinate, that’s what I take issue with,” Ellis said. “I would much rather vaccination be available at birth than to have someone else live the experience that I’ve lived.
“I’m a living, breathing example of what the risks are.”
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