Kennedy's Advisers Weigh Hepatitis B Vaccine Timing

A group of vaccine advisers to Robert F. Kennedy Jr. will consider on Thursday whether to delay hepatitis B shots for the vast majority of American children in what would be the most significant change yet to U.S. vaccination policy under the health secretary.

The two-day meeting of the CDC's Advisory Committee on Immunization Practices will also see a vote on whether parents, in consultation with healthcare providers, should be able to choose between giving newborns the hepatitis B vaccine at birth or waiting until at least two months, if the mother tests negative or has not been tested for the virus.

The vaccine advisers will also consider whether parents should consult with healthcare providers about getting a blood test before the next hepatitis B vaccine dose, and whether insurance should cover that test.

Kennedy, who has been known for his criticism of certain vaccine policies prior to becoming the nation’s top health official, has introduced several policy changes. These include ending broad federal recommendations for Americans to receive COVID-19 vaccinations, advising that the measles-mumps-rubella and varicella vaccines be administered separately for children under age 4, implementing new requirements for vaccine trials, and reducing federal funding for mRNA-based vaccine programs.

Currently, the U.S. Centers for Disease Control and Prevention recommends three doses of the hepatitis B shot, with the first given within 24 hours of birth. The subsequent doses at 1 to 2 months and 6 to 18 months are generally administered as part of combination shots to prevent other diseases like polio and pertussis.

The committee has not settled on exactly how long to recommend pushing them back, Dr. Kirk Milhoan, a pediatric cardiologist who chairs ACIP, said in an interview on Monday.

If the recommendation for the hepatitis B vaccine is delayed past ages 2 or 3 months, pediatricians might avoid using those combination vaccines, Demetre Daskalakis, former director at the CDC's National Center for Immunization and Respiratory Diseases, said ahead of the meeting.

That could lead to supply problems for at least a year, he and other manufacturing experts said.

The committee advises the CDC on what recommendations to adopt, which affects health insurance coverage in the United States, and plays a key role in assisting physicians in choosing appropriate vaccines for patients.

The U.S. universal birth dose policy, adopted in 1991, has cut infections in children by more than 95%, according to a review of more than 400 studies and reports by independent vaccine experts released on Tuesday.

Hepatitis B, a viral infection spread through blood and other body fluids, can cause serious liver disease. Infants infected in their first year have a 90% chance of developing chronic infection, increasing the risk of serious liver disease such as cirrhosis or cancer.

Sources at manufacturers told Reuters the committee has not asked for data or details on how a significant inoculation schedule change could impact vaccine supply.

Merck and GSK make hepatitis B shots and Sanofi makes a combination shot with Merck that includes six different vaccines.

In September, the restructured ACIP panel postponed a vote on whether to delay the hepatitis B birth dose. Kennedy had earlier replaced the 17 members who previously served on the committee.
President Donald Trump had suggested delaying the first hepatitis B dose until age 12, arguing the virus is largely sexually transmitted.

But more than 10% of infected children had mothers who tested negative, Daskalakis said, noting caregivers can spread the virus at home or in daycare.

Delaying the hepatitis B birth dose to 2 months for infants whose mothers are not known to have the virus could lead to at least 1,400 preventable infections in children, 300 additional liver cancer cases and 480 avoidable deaths, according to an analysis by researchers and public health practitioners in partnership with hepatitis advocacy groups.