The researchers determined whether hepatitis B vaccination of newborns increases the incidence of fever and/or suspected sepsis, and reported their findings in the November issue of the Pediatric Infectious Disease Journal.
A prospective clinical study was undertaken at the Kaiser Permanente San Francisco Medical Center, involving normal full term newborns born between 1 November 1991 and 30 April 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. Laboratory data for blood and cerebrospinal fluid (CSF) cultures were obtained from the comprehensive automated regional laboratory reporting system.
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), allergic reactions, seizures, or other neurologic events in the first 21 days of life.
The investigators found that 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.
| Vaccinated newborns less likely to undergo evaluation for sepsis.
| Pediatric Infectious Disease Journal |
Edwin Lewis, of the Kaiser Permanente Vaccine Study Center, Oakland, California, said on behalf of fellow authors, "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," it was concluded.