Reactions 786 - 29 Jan 2000

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No clear increase in neonatal deaths after HBV vaccine A review of reports of neonatal death following hepatitis B virus (HBV) vaccination received by the US national Vaccine Adverse Event Reporting System (VAERS) may provide some reassurance that HBV vaccination is not associated with an increase in the risk of unexplained neonatal death in the US, say researchers from the US. In total, 1771 adverse events in neonates following HBV vaccination,* including 18 deaths, were reported to VAERS from 1 January 1991** to 5 October 1998. The causes of neonatal death as recorded by the medical examiner at autopsy† were as follows: sudden infant death syndrome (SIDS; 12 neonates), infection (3), intracerebral haemorrhage (1), accidental suffocation (1) and congenital heart disease (1). The mean age at the time of HBV vaccination was 12 days and the median time from vaccination to the onset of symptoms was 2 days. The researchers say that during the period when these adverse events were reported, at least 86 million doses of paediatric HBV vaccine were distributed in the US. They point out that from 1985 to 1996, the total number of neonatal deaths decreased from 7 to 4.8/1000 live births in the US. Also, from 1992–1996 the total number of SIDS cases reported to VAERS decreased by almost 50%. The researchers say that these indirect indices, despite having limited interpretability, provide some reassurance that HBV vaccination is not leading to a clear increase in unexplained neonatal or infant death in the US. * given alone rather than simultaneously with other vaccines ** In 1991, HBV vaccine became the first vaccine recommended for universal administration to neonates. † 1 neonate did not undergo autopsy Niu MT, et al. Neonatal deaths after hepatitis B vaccine: the vaccine adverse event reporting system, 1991-1998. Archives of Pediatrics and Adolescent Medicine 153: 800811303 1279-1282, Dec 1999

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Reactions 29 Jan 2000 No. 786