ACIP Changed Hepatitis B Birth Dose Recommendations. Now What?

The Advisory Committee on Immunization Practices (ACIP) made some big decisions this week that carry significant implications for America’s babies and children. The meeting, which took place December 4 and 5 at the Centers for Disease Control and Prevention (CDC), brought together the committee members (all added by Robert F. Kennedy Jr. in recent months) to vote on the hepatitis B birth dose and to discuss childhood vaccine schedules and aluminum adjuvants.

Changes to the Hepatitis B Birth Dose 

• The committee voted to end the recommendation for universal hepatitis B vaccinations at birth.
• Instead, they recommended that, for babies born to hepatitis B negative mothers, parents consult with a medical provider about if or when to start the hepatitis B vaccine series—including the birth dose—with the suggestion to not begin earlier than 2 months.
• The recommendations suggest that babies not vaccinated at birth should receive a first shot at two months, with additional shots in the three-part series recommended based on the results of antibody testing.
• This is a major departure from the previous guidance, which advised vaccination at birth.

Options for Parents and Families

• People can still choose for their babies to receive the hepatitis B birth dose in consultation with their doctor.
• Families without insurance will still be able to receive hepatitis B vaccines (including a birth dose, if they choose it) for free through the Vaccines for Children Program.

Why the Hepatitis B Birth Dose Matters

 People who contract hepatitis B before the age of 1 have a 90% chance of developing chronic hepatitis B. The infectious disease is incurable and can lead to severe illness, including cancer. About 25% of people with chronic hepatitis B will die from it. 

• The hepatitis B birth dose is a safe and effective community health practice that provides both infant and community benefits.
• Since the United States began administering the hepatitis B vaccine at birth, the rates of pediatric hepatitis B have declined by 99%.
• Administering the hepatitis B vaccine later leaves babies vulnerable to hepatitis B at a time when they are at greatest risk for developing severe illness and chronic disease. 

"We give the hepatitis B vaccines early on, and we give it routinely,” says Stephen Patrick, MD, chair of the Department of Health Policy and Management at Rollins. “It is very well tolerated. It also reduces the risk of transmission from mom to baby or from communities. We know that infants are at much higher risk of developing chronic inflammation of their liver if they are infected.”

Delaying the Birth Dose Could Be Expensive for Americans and Bad for Health

In advance of the ACIP meeting, Heather Bradley, PhD, associate professor of epidemiology at Rollins, and colleagues developed a model to predict how expensive this change could be—both to Americans’ health, and their wallets. She and colleagues published the findings as a pre-print in advance of the ACIP meeting.

Bradley and team estimated that delaying the hepatitis B vaccination to 2 months among infants of mothers not known to be living with hepatitis B could lead to: 

• 1,437 preventable infections
• 300 cases of liver cancer
• 480 deaths
• $222 million in excess health costs for each year the recommendations are in place.

Negative health outcomes and costs would only increase the older the child is before they begin the series.

“It is important to understand these costs accumulate for each year the new recommendation is in place,” says Bradley. “These avoidable health care costs should be weighed against a vaccine for which we have decades of safety and effectiveness data. There is no evidence to support delaying the birth dose and plenty of evidence to support maintaining the current recommendation, including from our model.”

The Medical Community Disagrees with Delaying the Birth Dose

Earlier this week, the Northeast Public Health Collaborative put out a statement recommending that all newborns receive the Hepatitis B vaccine within 24 hours of life. The American Academy of Pediatrics also continues to recommend vaccination within 24 hours of birth, with additional shots at 1 or 2 months, and a third between 6 and 18 months.