Neonatal Deaths After Hepatitis B Vaccine
The Vaccine Adverse Event Reporting System, 1991-1998
Manette T. Niu, MD; Marcel E. Salive, MD, MPH; Susan S. Ellenberg, PhD
Objective To evaluate reports of neonatal deaths (aged 0-28 days) after
hepatitis B (HepB) immunization reported to the national Vaccine Adverse
Event Reporting System (VAERS).
Design Case series; review of autopsy reports.
Setting Voluntary reports submitted to VAERS, a passive surveillance system,
from the US population.
Patients All US neonates (0-28 days of age) whose deaths after HepB
vaccination given alone were reported to VAERS, occurring from January 1,
1991, through October 5, 1998.
Intervention None (observational database).
Results Of 1771 neonatal reports, there were 18 deaths in 8 boys and 9 girls
(1 patient unclassified). The mean age at vaccination for these 18 cases was
12 days (range, 1-27 days); median time from vaccination to onset of symptoms
was 2 days (range, 0-20 days); and median time from symptoms to death was 0
days (range, 0-15 days). The mean birth weight of the neonates (n = 15) was
3034 g (range, 1828-4678 g). The causes of death for the 17 autopsied cases
were sudden infant death syndrome for 12, infection for 3, and 1 case each of
intracerebral hemorrhage, accidental suffocation, and congenital heart
Conclusion Few neonatal deaths following HepB vaccination have been
reported, despite the use of at least 86 million doses of pediatric vaccine
given in the United States since 1991. While the limitations of passive
surveillance systems do not permit definitive inference, these data suggest
that HepB immunization is not causing a clear increase in neonatal deaths.
Arch Pediatr Adolesc Med. 1999;153:1279-1282
Editor's Note: This report should help allay the fears of the antivaccine
groups; it should, but will it?-Catherine D. DeAngelis, MD
From the Division of Biostatistics and Epidemiology, Center for Biologic
Evaluation and Research, US Food and Drug Administration, Rockville, Md.
Reprints: Manette T. Niu, MD, Food and Drug Administration, Center for
Biologic Evaluation and Research, Division of Biostatistics and Epidemiology,
1401 Rockville Pike, HFM-210, Rockville, MD 20852-1448 (e-mail:
Accepted for publication May 6, 1999.
We thank Frederick Varricchio, MD, PhD; Peter Patriarca, MD; and Gina T.
Mootrey, DO, MPH, for critical review of the manuscript, and Carol Krueger,
RN, BSN, for technical support.
© 1999 American Medical Association. All rights reserved.