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Safety of neonatal hepatitis B vaccine administration

Lewis, Edwin MPH; Shinefield, Henry R. MD; Woodruff, Bradley A.*; Black, Steven B. MD; Destefano, Frank MD; Chen, Robert T. MD; Ensor, Richard MAThe Vaccine Safety Datalink Workgroup

The Pediatric Infectious Disease Journal: November 2001 - Volume 20 - Issue 11 - p 1049-1054
Original Studies

Objective. To determine whether hepatitis B vaccination of newborns increases the incidence of fever and/or suspected sepsis.

Methods. A prospective clinical study was undertaken at the Kaiser Permanente San Francisco Medical Center involving normal full term newborns born between November 1, 1991, and April 30, 1994. During this time 3302 infants were vaccinated within 21 days of birth with hepatitis B vaccine, and 2353 were not. Clinical and demographic data were collected from Kaiser Permanente’s existing clinical information systems, and laboratory data for blood and cerebrospinal fluid (CSF) cultures were obtained from the comprehensive automated regional laboratory reporting system.

Results. There were no significant differences between vaccinated and unvaccinated newborns in the proportion of infants who received care for fever (0.8% vaccinated and 1.1% unvaccinated, P = 0.28), allergic reactions, seizures or other neurologic events in the first 21 days of life. Vaccinated newborns were significantly less likely to undergo microbiologic evaluation for possible sepsis. Among vaccinated newborns 4.0% had blood cultures and 1.6% had CSF cultures. Among infants who were not vaccinated 8.3% had blood cultures and 1.6% had CSF cultures (P <0.001 for both tests).

Conclusion. This study found no evidence that newborn hepatitis B vaccination is associated with an increase in the number of febrile episodes, sepsis evaluations or allergic or neurologic events. In addition our data did not support any increase in medical procedures attributed to receipt of hepatitis B vaccine.

From the Kaiser Permanente Vaccine Study Center, Oakland, CA (EL, HRS, SBB, RE); and the Hepatitis Branch (BAW) and National Immunization Program (FD, RTC), Centers for Disease Control and Prevention, Atlanta, GA.

Accepted for publication June 1, 2001.

*Current address: International Emergency and Refugee Health Branch, CDC, Atlanta, GA.

Address for reprints: Henry R. Shinefield, M.D., Kaiser Permanente Vaccine Study Center, One Kaiser Plaza 16th Floor, Oakland, CA 94610. Fax 510-267-7524; E-mail

© 2001 Lippincott Williams & Wilkins, Inc.