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Recombinant hepatitis B vaccination of neonates and infants: emerging safety data from the Vaccine Adverse Event

M T Niu1, D M Davis, S Ellenberg

  • 1Division of Biostatistics and Epidemiology, Office of Establishment Licensing, US Food and Drug Administration, Rockville, MD 20852-1448, USA. Niu@al.cber.fda.gov

The Pediatric Infectious Disease Journal
|September 1, 1996
PubMed

Insights

Postmarketing surveillance of the recombinant hepatitis B (HB) vaccine in US infants and neonates revealed no unexpected serious adverse events. This safety review analyzed reports from the Vaccine Adverse Events Reporting System (VAERS).

Area of Science:

  • Immunology
  • Vaccinology
  • Public Health

Background:

  • The recombinant hepatitis B (HB) vaccine is widely administered to neonates and infants in the US.
  • Postmarketing surveillance is crucial for assessing vaccine safety in real-world settings.
  • Understanding adverse events temporally associated with HB vaccination is essential for public health.

Purpose of the Study:

  • To evaluate the postmarketing safety profile of the recombinant hepatitis B (HB) vaccine in neonates and infants.
  • To identify and characterize adverse events reported following HB vaccination in young children.
  • To assess the safety of HB vaccine when administered alone or in combination with other routine childhood vaccines.

Main Methods:

  • A case series review of reports submitted to the national Vaccine Adverse Events Reporting System (VAERS) in the US.
  • Analysis of reports received between January 1, 1991, and May 31, 1995, specifically for neonates and infants.
  • Comparison of adverse events reported for HB vaccine alone versus HB vaccine in combination with diphtheria-tetanus-pertussis (DTP) vaccine.

Main Results:

  • Over 12,500 VAERS reports were associated with HB vaccination between 1991-1994, with 14% concerning neonates and infants.
  • Serious adverse outcomes were more frequently reported in neonates (<0.1 years) compared to older age groups (40% vs. 6-15%).
  • Adverse events in infants receiving HB/DTP were similar to those receiving DTP alone, suggesting a potential association with DTP rather than HB vaccine.

Conclusions:

  • The review found no unexpected serious adverse events associated with the recombinant hepatitis B vaccine in neonates and infants.
  • Despite limitations in distinguishing coincidental events from true vaccine reactions, the VAERS database provides valuable safety insights.
  • Over 12 million doses of HB vaccine administered to these age groups did not reveal new safety concerns.
Abstract

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