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“The results indicated that whole-cell DTP vaccine contained high levels of endotoxin<br />

and was statistically significantly more reactogenic than acellular DTaP vaccine.”<br />

Pediatric Rehabilitation • July 2002<br />

Serious neurological conditions following pertussis immunization:<br />

an analysis of endotoxin levels, the vaccine adverse events reporting<br />

system (VAERS) database and literature review<br />

Author information<br />

Geier DA1, Geier MR.<br />

MedCon, Inc., Silver Spring, MD, USA<br />

Abstract<br />

The purpose of this study was to determine the potential risks for the development and outcome of serious neurological<br />

illnesses following whole-cell DTP vaccination and also to determine if the switch to using acellular DTaP<br />

vaccine in the US has had any effect on the incidence rate of serious neurological illnesses following vaccination.<br />

This study used the Limulus amebocyte lysate (LAL) endotoxin assay to determine the levels of endotoxin<br />

in various commercially available whole-cell and acellular DTaP vaccines, analysed the Vaccine Adverse Events<br />

Reporting System (VAERS) database to determine the clinical effects of the use of whole-cell DTP and acellular<br />

DTaP vaccines in the US and reviewed recently published pertinent studies that analysed the incidence rates of<br />

serious neurological illness following whole-cell DTP and acellular DTaP vaccines. The results indicated that<br />

whole-cell DTP vaccine contained high levels of endotoxin and was statistically significantly more reactogenic<br />

than acellular DTaP vaccine. The presence of bias in the VAERS database was not borne-out. The recommendation<br />

by the American Academy of Paediatrics to use acellular DTaP vaccine for the entire childhood vaccination<br />

schedule beginning in 1996 and the absence of the availability of whole-cell DTP in the US beginning in 2001<br />

seems well justified based upon the results of this study.<br />

http://www.ncbi.nlm.nih.gov/pubmed/12587565

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