CDC’s vaccine advisory panel to vote on hepatitis B, COVID-19 vaccines for fall season

The Advisory Committee on Immunization Practices’ Thursday session targeted on hepatitis B and the mixed measles, mumps, rubella and varicella (MMRV) vaccines. 

The committee voted to vary its advice on the MMRV vaccine, saying “the mixed MMRV vaccine will not be beneficial” earlier than age 4. As a substitute, the group recommends youngsters on this age group obtain a separate measles-mumps-rubella vaccine and varicella vaccine, or MMR+V.

After finishing displays and discussions on the hepatitis B matters, the vote on that was pushed to Friday.

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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.”

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. 

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.

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.