The influential vaccine advisory committee that Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. remade to reflect his views will meet this week to vote on childhood hepatitis B vaccinations for newborns as well as children’s immunization schedules.
After months of delay, the panel is poised to tackle the topic on Thursday and Friday, as some medical professionals and lawmakers question the possible policy change.
“It’s a good idea to review recommendations every now and then, especially if there has been new evidence coming out or new innovations in a particular field,” Chari Cohen, president of the Hepatitis B Foundation, told The Hill. “And especially if that review is done systematically, methodically, scientifically and transparently.”
“Right now, we have a situation where none of that has happened,” she added.
In September, the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention (CDC) delayed a vote on a recommendation to push back the timing of newborns’ hepatitis B vaccination, which typically happens within 24 hours of birth.
The committee was asked to consider postponing the immunization to when an infant is one month old if their mother tests negative for the virus, with an added caveat that the shot could be administered sooner based on “individual based decision-making.”
This move was criticized by medical organizations as well as Republican Sen. Bill Cassidy (La.), a hepatologist and chair of the Senate Committee on Health, Education, Labor and Pensions.
Vaccine critic Martin Kulldorff, who was appointed to a role within HHS earlier this week but served as ACIP chair at the time of the September meeting, argued that getting rid of vaccine mandates would help reestablish trust in public health.
However, there is no hepatitis B vaccine mandate in the U.S., and parents can decide whether to vaccinate their newborn against the infection.
Some ACIP members have taken issue with the confusing wording of the recommendation. Cody Meissner, a member, spoke out, saying, “We will increase the risk of harm based on no evidence of benefit, because there will be fewer children who will get the full hepatitis B vaccine series.”
Others expressed concerns that endorsing the recommendation would result in children losing insurance coverage for vaccinations, including those who rely on the federal Vaccines for Children program.
Now, the committee will confront these questions about modifying hepatitis B vaccine guidance once again.
Those in the hepatology space are already anxious over potential changes to decades-old guidance that has helped to drastically bring down hepatitis infections in the U.S.
The Center for Infectious Disease Research and Policy and the Vaccine Integrity Project issued an independent evidence review Tuesday supporting this conclusion.
“The hepatitis vaccine has consistently been shown to be a safe vaccine, regardless of timing of vaccination. This analysis found no differences in short-term or long-term adverse events related to the birth dose compared with a delayed first dose,” the report concluded.
“No benefits of vaccine efficacy, effectiveness, or long-term protection were identified in delaying the first dose compared with vaccination at birth,” it continued.
As of November, Cassidy also remains concerned about the possible policy change.
“This is policy by people who don’t understand the epidemiology of hepatitis B, or who have grown comfortable with the fact that we’ve been so successful with our recommendation that now the incidence of hepatitis B is so low, they feel like we can rest on our laurels,” the Louisiana Republican said on CBS’s “Face The Nation.”
The Hill has reached out to Cassidy’s office for comment.
One of the arguments against immunizing newborns against hepatitis B is that the virus is sexually transmitted and infants aren’t at risk of infection.
But mothers can pass the virus onto their child, and Cohen noted only a “microscopic” amount of blood can lead to an infection.
“We know that in the U.S., 70 percent of people that are living with the hepatitis B virus are undiagnosed,” said Cohen. “So, we don’t know when babies go home, who’s going to be caring for them, whether it’s in the house, in the neighborhood, in the community, in daycare. We don’t know who has hepatitis B or not, and we shouldn’t have to rely on that.”
In September, the ACIP recommended that all pregnant women get tested for hepatitis B. Cohen is supportive of this guidance, but said that 16 percent of pregnant women are unaware of their hepatitis status.
The consequences of contracting hepatitis B as an infant or child can be fatal. An individual who contracts the virus in early childhood has a 25 percent chance of dying young due to liver cancer, Cohen said.
A report from HepVu, the Hepatitis B Foundation and the National Viral Hepatitis Roundtable projected that delaying hepatitis B vaccination could lead to thousands of preventable infections.
Modeling found that, if immunization is delayed by two months, there would be 238 additional infections among children and an added $21.6 million in healthcare costs.
“The main takeaway here is that our modeling efforts indicate that even short delays across any time points of vaccination will lead to substantially more infections, long term health complications and sharp increases in health care spending,” said Eric Hall, an assistant professor at Oregon Health and Science University and co-author of the report.
“The further out those delays are pushed, the more infections will occur, and the higher health care related costs will be,” he added, noting the modeling was carried out in direct response to the changes under consideration by ACIP.