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Ann Pharmacother. 2002 May;36(5):776-80.

Clinical implications of endotoxin concentrations in vaccines.

Author information

1
Genetic Centers of America, 14 Redgate Court, Silver Spring, MD 20905-5726, USA.

Abstract

BACKGROUND:

A previous study suggested that high concentrations of endotoxin may be present in whole-cell diphtheria/tetanus/pertussis (DTP) vaccine, and the scientific literature contains many studies examining the reactivity of whole-cell DTP vaccine. The medical and scientific communities have previously reported that the presence of endotoxin in commercial vaccines may have negative effects on vaccine recipients.

OBJECTIVE:

To determine the endotoxin concentrations in whole-cell DTP, acellular DTP(DTaP), and DT vaccines and determine the clinical experience with each vaccine.

METHODS:

To study the endotoxin concentrations in vaccines, the Limulus amebocyte lysate (LAL) assay was used. The vaccines analyzed with the LAL assay were whole-cell DTP vaccine lots manufactured by Connaught, Lederle, the Michigan and Massachusetts Departments of Health, and Wyeth; DTaP vaccine lots manufactured by Merieux and Takeda; and DT vaccine lots manufactured by Wyeth and Lederle. The incidence of adverse reactions following whole-cell DTP, DTaP, and DT vaccines were determined based on analysis of the Vaccine Adverse Events Reporting System (VAERS) database.

RESULTS:

The results of the LAL assay showed that whole-cell DTP vaccines contained considerably more endotoxin than either DTaP or DT vaccines. The VAERS showed that statistically significantly more adverse reactions were associated with whole-cell DTP vaccine than DTaP or DT vaccines.

CONCLUSIONS:

This analysis confirmed higher concentrations of endotoxin in whole-cell DTP vaccines compared with DTaP or DT vaccines. As high concentrations of endotoxin may be correlated with a higher incidence of adverse events, the switch from whole-cell DTP to DTaP for routine vaccinations in the US seems well justified.

PMID:
11978151
DOI:
10.1345/aph.1A410
[Indexed for MEDLINE]

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