The US Centers for Disease Control and Prevention (CDC) vaccine advisory panel today voted to postpone a vote on delaying the birth dose of hepatitis B vaccine, given that most members felt more data was needed to inform the wording of the recommendation.
In another vote, the Advisory Committee on Immunization Practices (ACIP) reversed a Vaccines for Children (VFC) program vote it took yesterday on the measles, mumps, rubella, and varicella (MMRV) vaccine for children younger than 4 years old. The reversal removes the vaccine from the federal program that provides free vaccine to uninsured and underinsured children.
The vote is unusual, because yesterday on the main voting question the group removed its recommendation that children in the youngest age-group can get the MMRV vaccine when caregivers consult with doctors about the low risk of febrile seizures, but kept in place VFC inclusion for the vaccine, whose varicella component protects against chickenpox.
Demands for formal, science-based recommendation proposals
The decision to table the hepatitis B vaccines measures passed on an 11-to-1 vote, with ACIP Chair Martin Kulldorff, PhD, as the only no vote. Kulldorff is a statistician and epidemiologist formerly at Harvard University.
Ahead of the vote, the advisers unanimously passed the first part of the hepatitis B voting question, which recommends that all pregnant women be screened for hepatitis B, which is already the standard of care in the United States and many other countries.
Multiple members, however, said the wording of the proposed recommendations to postpone the hepatitis vaccine birth dose to 1 month after birth lacked evidence and had wording that created ambiguity regarding clinical decision making.
Tell the public how you’re vetting vaccines.
Confusion about the vote prompted strong demands from some ACIP and liaison member members that, going forward, ACIP use the usual work group format to formulate the voting questions and back the recommendations with science, using its long-standing grading and methodology that takes into account risk-benefit and equity analyses.
Jason Goldman, MD, a representative with the American College of Physicians and an assistant professor of clinical biomedical science at Florida Atlantic University, said he applauded the group's delaying of the hepatitis B vote, but said that ACIP members need to be transparent about how they’re evaluating vaccines. “Tell the public how you’re vetting vaccines.”
Vote challenges strong public health track record
Hepatitis B spreads through infected body fluids and is much more infectious than HIV. The CDC has estimated that 640,000 US adults have chronic hepatitis B infections, though many are asymptomatic, increasing the risk of household exposure. Antiviral drugs can help prevent liver damage, but there is no cure. Compared to adults, children who contract the virus are at sharply greater risk of developing chronic disease.
Infected mothers can pass the virus to babies during birth, and though pregnant women are typically screened for hepatitis B during the first trimester, tests aren’t perfect, and women can still contract infections during the last two trimesters.
To prevent impacts from screening gaps, in 1991 ACIP recommended that all infants receive their first dose of hepatitis B vaccine at birth, which is credited with dropping the rate of infections in children and teens by 99% in the decades that followed. Babies typically receive three doses, the first one at birth.
During yesterday’s ACIP presentations, Adam Langer, DVM, MPH, associate director for Science at CDC's National Center for HIV, Viral Hepatitis, STD, and TB Prevention, whose presentation addressed questions raised earlier by ACIP members, noted that 36 countries have hepatitis B birth-dose policies, with others vaccinating soon after. He said none have reversed their birth-dose policies and that more countries are working toward adopting birth-dose policies.
Sen Bill Cassidy, MD, (R-LA), who leads the Senate HELP committee, has been vocal about the benefits of hepatitis B vaccine. Earlier this month on X, he said people objecting to the vaccine have never treated patients who died from liver disease or required transplantation. Alongside slides of physical symptoms in sick patients, he wrote, “This is about preventing illnesses like this. I have the experience of treating patients infected with hepatitis B at birth, who end up terribly ill like this. Why would anyone want someone to end up like this?”
'We will increase the risk of harm'
In yesterday’s deliberations, some ACIP members questioned the scientific basis of the proposed recommendation. Cody Meissner, MD, who has served on both CDC and Food and Drug Administration vaccine advisory committees and is a professor of pediatrics at Dartmouth Geisel School of Medicine, said he’s not aware of any data that the hepatitis B vaccine is safer when given at 2 months or 3 months, for example. “I’m not sure what we’re gaining by avoiding that first dose,” he said.
“If we change the recommendation for neonatal administration, we will increase the risk of harm, with no evidence of benefit,” he added. “This is an extremely safe, pure vaccine. We will be creating new doubts in the public that aren’t justified.”
He also pointed out that the practice of medicine isn’t precise, and that, as with HIV, it’s difficult to identify all patients with risk factors. Meissner also raised concerns about the overall effort to narrow vaccine target groups. “The more we try to define a target group, the less successful we are.”
This is an extremely safe, pure vaccine. We will be creating new doubts in the public that aren’t justified.
At the end of the main policy discussion, several liaison members representing medical groups asked ACIP members to explain what problems in the childhood vaccine schedule are prompting the proposed changes, which some said raises equity questions about potential consequences for a growing underinsured population
Robert Malone, MD, vaccinologist and scientist who was involved in early mRNA vaccine research, replied that ACIP has proposed the changes due to Americans’ lack of trust in vaccines in the wake of COVID and sensitivities to a medical intervention delivered during the newborn period.
