NEW YORK (Reuters Health) – Hepatitis B vaccine administration within the first 21 days of life is not associated with an increase in febrile episodes, allergic or neurologic events or suspected sepsis, according to the results of a study conducted at Kaiser Permanente San Francisco Medical Center.
Although the vaccine is recommended for routine use in infants by the American Academy of Pediatrics, there have been anecdotal reports of an increased incidence of fever among newborns who receive this vaccine.
To further investigate, Dr. Henry R. Shinefield, of the Kaiser Permanente Vaccine Study Center, in Oakland, California, and multicenter colleagues conducted a randomized trial of neonatal hepatitis B vaccination with more than 5000 infants born between November 1, 1991, and April 30, 1994. A total of 3302 infants were vaccinated within 21 days of birth and the remaining 2353 were not. All infants were full-term and healthy.
The researchers found no differences between the two groups of infants in the incidence of fever, allergic reactions, seizures, or other neurologic events, they report in the November issue of The Pediatric Infectious Diseases Journal. Moreover, vaccinated infants were significantly less likely than unvaccinated infants to undergo evaluation for sepsis, contrary to prior anecdotal reports (p < 0.001).
The findings should allay concerns about the safety of neonatal hepatitis B vaccination, a potential obstacle to routine infant vaccination.
Pediatr Infect Dis J 2001;20:1049-1054.
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