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19 - Vaccine toxicology: nonclinical predictive strategies

from II - INTEGRATED APPROACHES OF PREDICTIVE TOXICOLOGY

Published online by Cambridge University Press:  06 December 2010

By
Sarah Gould  and
Raymond Oomen
Edited by
Jinghai J. Xu  and
Laszlo Urban
Jinghai J. Xu
Affiliation:
Merck Research Laboratory, New Jersey
Laszlo Urban
Affiliation:
Novartis Institutes for Biomedical Research, Massachusetts
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Summary

INTRODUCTION

Vaccines are one of the safest and most effective preventative treatments against infectious diseases. The first vaccine was against smallpox, and developed by Edward Jenner (1796) as a simple preparation of crude vaccinia. Today's vaccines are composed of a diverse range of products, which may include live attenuated or inactivated bacteria, virus or parasites, living irradiated cells, crude fractions or purified parts of microorganisms, polysaccharides, toxoids, recombinant proteins/polypeptides, and vector-based and DNA vaccines. Formulations may include novel adjuvants, excipients, and multiple antigen combinations and be delivered by novel routes via viral vectors or new delivery systems. Vaccines also offer wider possibilities with the promise of therapeutic benefit against various disorders such as cancer, prevention or treatment of immune-mediated diseases, and antismoking therapy.

Vaccines have an exemplary safety record, with a benefit that is immeasurable. With today's risk-averse society and heightened awareness, vaccine safety attracts intense scrutiny, particularly in the case of preventative vaccines, which are given to healthy adults, infants, and children. The safety benefit ratio is skewed heavily toward safety and as many infectious diseases are not prevalent today, many people may not perceive the benefit. In fact, in recent years, there has been a shift toward a risk benefit for the individual, and as a result of certain alleged safety issues, there has been a reduction in vaccinations, (e.g., Japan and DTP vaccines, MMR in UK, polio in African regions); this will ultimately lead to decreased herd immunity, and the prevalence of certain diseases may return.

Type
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Predictive Toxicology in Drug Safety , pp. 344 - 370
Publisher: Cambridge University Press
Print publication year: 2010

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