Committee revotes on Vaccines for Children program resolution
After kicking off Friday’s meeting with a roll call of members and liaisons, ACIP chair Martin Kulldorff said there was discussion on “what to do” about two conflicting votes that took place the day prior.
During Thursday’s meeting, after much confusion among the members over the vote on vaccine coverage under the Vaccines for Children program, which helps certain groups pay for immunizations, the majority voted no. This meant coverage would stay as is for covering both the combined MMRV and two separate MMR+V vaccines for those under age 4 — even though the committee had previously voted against recommending the combined MMRV shot for this age group.
In Friday’s meeting, the vote changed to 9 yes and 3 abstentions.
“I just want to stress that what all this means is that every child, including every child in the vaccine program — the Vaccines for Children program — will have access to be vaccinated against measles” mumps, rubella and chickenpox, Kulldorff said.
Committee shares proposed hepatitis B vaccine recommendation changes ahead of vote
On the topic of hepatitis B, there will be votes Friday on two different recommendation changes.
The language for the first proposed change was presented as: “All pregnant women should be tested for hepatitis B infection.”
The second proposed change would say that if the mother tests negative for hepatitis B:
- The first dose of the hepatitis B vaccine is not given until the child is at least one month old.
- Infants may receive a dose of hepatitis B vaccine before one month according to individual based decision-making. (Also referred to as shared clinical decision-making.)
ACIP expected to consider COVID-19 vaccine recommendations
Ahead of the meetings this week, CDC insiders said they expected the panel to consider potentially narrowing of the list of conditions that would classify someone as being at high risk for severe COVID. That shift could mean fewer people would be recommended for vaccination, even if they might still benefit.
Dr. Lakshmi Panagiotakopoulos, a prior ACIP working group lead who resigned from the CDC earlier this year, warned that limiting recommendations could send the wrong signal, saying, “People may interpret a narrower recommendation as meaning the vaccine doesn’t work, when in fact it’s still highly protective against severe disease.”
The possible exclusion of healthy pregnant women and healthy infants from the high-risk category is also drawing attention. Pregnancy and early infancy have long been recognized as periods of elevated vulnerability, and experts worry that dropping these groups from the recommendation would not only reduce their protection but would erode public confidence in maternal and pediatric vaccination.
Last month, the American Academy of Pediatrics (AAP) recommended that all infants and toddlers aged 6 to 23 months receive the COVID vaccine. The group cited data showing that children under 2 have the highest COVID hospitalization rates among pediatric age groups, and that more than half of those hospitalized had no underlying conditions.
The Society for Maternal-Fetal Medicine, the national organization representing high-risk pregnancy experts, has reaffirmed its recommendation that all pregnant and breastfeeding women receive the COVID vaccine.
Day 1 of meetings focused on measles and hepatitis B vaccines
The Advisory Committee on Immunization Practices’ Thursday session focused on hepatitis B and the combined measles, mumps, rubella and varicella (MMRV) vaccines.
The committee voted to change its recommendation on the MMRV vaccine, saying “the combined MMRV vaccine is not recommended” before age 4. Instead, the group recommends children in this age group receive a separate measles-mumps-rubella vaccine and varicella vaccine, or MMR+V.
After completing presentations and discussions on the hepatitis B topics, the vote on that was pushed to Friday.
Some ACIP members clashed in discussion on hepatitis B shots
After presentations Thursday on the potential risks and benefits of hepatitis B vaccination at birth, some members of the advisory committee clashed on what the data meant for the vote they will be taking.
Dr. Cody Meissner, a pediatrics professor who previously served as a member of the Food and Drug Administration’s vaccines panel, called the vaccine “safe” with “no evidence of harm.”
If the recommendation changes, he said, it would “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.”
“This an absolutely safe vaccine,” he said. “I’m not sure what we’re gaining by avoiding that first dose within 12 to 24 hours after birth.”
Member Vicky Pebsworth, a regional director of the National Association of Catholic Nurses, disagreed, saying “there are gaps in what we know and understand about the effects of hepatitis B, particularly on very young infants, and I think that the conclusion that it is safe is perhaps premature.”
Changing hep B recommendation could put more infants at risk, presenter said
In a presentation Thursday on the hepatitis B vaccine, Dr. Adam Langer with the CDC outlined how changing the current recommendation could put more children at risk. The vaccine is currently recommended for newborns at birth.
Some argue the vaccine isn’t needed if a baby’s mother isn’t infected. But Langer listed a number of situations where unvaccinated infants could be at risk even if their mother tested negative for the disease when they were born:
- They live with a person who has chronic hepatitis B, not necessarily their mother.
- Someone who has an infection comes to visit their home.
- They go to daycare or other places where even “minuscule amounts of infectious blood or fluids might be present.”
“About half of people with HBV infection are unaware of their infection so they could unknowingly expose infants that are in their care,” he said.
The only potential benefit to rescinding the current recommendation is a potential reduction in rare cases of adverse effects from the birth dose vaccine, according to the presentation.
“When they do occur, these adverse events tend to be mild. The worst adverse event you could imagine, anaphylaxis, has been very rarely reported at only 1.1 cases per 1 million vaccine doses administered,” Langer said.
Current recommendations for hepatitis B vaccine
The panel is considering whether to support changes to the CDC’s recommendations for hepatitis B vaccination.
The CDC currently recommends the first dose of hep B vaccine for newborns within 24 hours after birth. Universal infant vaccination became the norm in 1991 after data showed too many cases of hepatitis B among pregnant women were missed during prenatal care.
Medical experts say a universal birth dose acts as a safety net, protecting infants whose parent’s infection might have been missed. Before birth-dose policies, the U.S. saw an estimated 1,000 preventable infections in newborns each year.
Proposed changes to the timeline would suggest delaying the first shot for one month if the mother tests negative, though families could choose to get it sooner.
Infection with hepatitis B can lead to serious health problems later in life, including liver damage, cirrhosis and liver cancer.
Kennedy’s newly appointed ACIP members include allies and vaccine critics
After firing all 17 of the committee’s previous members in June, HHS Secretary Robert F. Kennedy Jr. named eight new advisers to the ACIP, one of whom later withdrew. They include several allies he has worked with closely over the years and some who have a history as vaccine critics.
Kennedy appointed the new members directly, breaking with the past practice of agency officials vetting potential experts before sending them to the secretary for approval.
Then earlier this week, five more members were announced. The latest additions include some who have questioned established medical research on immunizations and the COVID-19 pandemic.
