Last December, the Centers for Disease Control and Prevention (CDC) recommended a change in the schedule for the hepatitis B virus (HBV) vaccine. Instead of vaccinating all children at birth, the children of mothers who test negative for HBV would receive their first vaccine dose at 2 months of age.

 

Following an investigation into the safety and efficacy of the HBV vaccine, the American Academy of Pediatrics (AAP) found no evidence supporting this change in vaccine recommendations.

 

“Chronic hepatitis B remains an incurable disease, underscoring the importance of primary prevention of infection,” wrote the study’s authors.

 

Hep B is a highly contagious virus that spreads through bodily fluids, including blood or semen. Thus, pregnant women who have HBV can pass it on to their infants during childbirth. Vaccines are the best way to prevent the spread of infection. Untreated HBV infection, or chronic hepatitis B, can cause serious liver complications, including cirrhosis and liver cancer.

 

To learn more about HBV, read Hep’s Hepatitis B Basics.

 

Since 1991, the CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended routine hep B screening during pregnancy and HBV vaccination of children at birth with periodic reviews of data confirming the safety and effectiveness of the practice.

 

Thanks to routine HBV vaccination, the number of new hep B cases in the United States has declined from about 260,000 a year in the 1980s to 21,000 in 2016, with the greatest decline occurring in children and adolescents.

 

The December rollback of HBV vaccinations at birth alarmed various health organizations, including the American Association for the Study of Liver Diseases.

 

“This irresponsible and purposely misleading guidance will lead to more hepatitis B infections in infants and children,” said AAP president Susan J. Kressly, MD, in a press release. “I want to reassure parents and clinicians that there is no new or concerning information about the hepatitis B vaccine that is prompting this change, nor has children’s risk of contracting hepatitis B changed. Instead, this is the result of a deliberate strategy to sow fear and distrust among families.”

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Researchers with the Vaccine Integrity Project of the Center for Infectious Disease Research and Policy at the University of Minnesota performed a comprehensive review of evidence related to newborn HBV vaccination since 1981 to determine the safety, immune response and efficacy of a birth dose and delayed dose. They gathered data from various sources, including clinical trials, public surveillance and safety data, clinical studies, vaccine formula changes and revised guidance.

 

The data confirmed the safety of the hep B vaccine, regardless of age at vaccination, and found no benefit to delaying the birth dose. Strengthened vaccine recommendations led to a 99% reduction in childhood HBV cases in the United States.

 

“The birth dose has served to close real-world gaps in prenatal screening and follow-up that left infants vulnerable to infection, including postnatal infections, errors across the continuum of care, missed opportunities for vaccination, gaps in early pediatric care and equitable access,” wrote the study’s authors. “The ACIP reviews did not present an analysis of the potential risks associated with delaying vaccination, including in the context of health equity.”

 

The study found no evidence supporting a change in the HBV vaccine schedule.

 

“These types of changes in recommendations are being done without full transparency by the current ACIP and by HHS [the Department of Health and Human Services, which is led by Robert F. Kennedy Jr.],” said the study’s lead author, Angela Ulrich, PhD, in a Medscape press release. “We would point people back to these four decades’ worth of information and evidence that we have that the vaccine is remarkably safe and it has protected thousands of young kids from getting a lifelong illness.”

 

To learn more about changes to HBV vaccine recommendations, click #Hepatitis B Vaccine.