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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
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.
Objectives:
To evaluate the postmarketing safety of recombinant hepatitis B (HB) vaccine given to neonates and infants in the US.
Methods:
US reports associated with HB vaccination and received between January 1, 1991, and May 31, 1995, by the national Vaccine Adverse Events Reporting System (VAERS) were reviewed as a case series.
Results:
During 1991 through 1994, 12,520 (32%) VAERS reports were received for events temporally associated with administration of HB vaccine, of which 14% were received for neonates and infants. More reports described serious outcomes for neonates (< 0.1 year old) than for other age groups (40% vs. 6 to 15%). HB alone was administered to 58 (97%) neonates; review of these reports did not reveal unexpected serious events. Among infants (0.1 to 0.9 years old) 192 (9%) received HB vaccine alone and 1469 (66%) received HB in combination with diphtheria-tetanus-pertussis (DTP) vaccine. Similar serious adverse events reported in neonates and infants included fever, agitation and apnea. Events reported for infants receiving HB/DTP and DTP alone were similar and differed from reports filed for infants receiving HB vaccine alone, suggesting that these events may be associated with use of DTP vaccine.
Conclusions:
This review shows no unexpected adverse events in neonates and infants given HB vaccine despite use of at least 12 million doses of vaccine given in these age groups. Although VAERS lacks the ability to distinguish coincidental events from true vaccine reactions, this database represents the largest case series of events temporally associated with HB vaccination of neonates and infants.