Assessing the safety of adjuvanted vaccines.

Abstract:

:Despite the very low risk-to-benefit ratio of vaccines, fear of negative side effects has discouraged many people from getting vaccinated, resulting in reemergence of previously controlled diseases such as measles, pertussis, and diphtheria. Part of this fear stems from the lack of public awareness of the many preclinical and clinical safety evaluations that vaccines must undergo before they are available to the general public, as well as from misperceptions of what adjuvants are or why they are used in vaccines. The resultant "black box" leads to a preoccupation with rare side effects (such as autoimmune diseases) that are speculated, but not proven, to be linked to some vaccinations. The focus of this review article is to open this black box and provide a conceptual framework for how vaccine safety is traditionally assessed. We discuss the strengths and shortcomings of tools that can be and are used preclinically (in animal studies), translationally (in biomarker studies with human sera or cells), statistically (for disease epidemiology), and clinically (in the design of human trials) to help ascertain the risk of the infrequent and delayed adverse events that arise in relation to adjuvanted vaccine administration.

journal_name

Sci Transl Med

authors

Ahmed SS,Plotkin SA,Black S,Coffman RL

doi

10.1126/scitranslmed.3002302

subject

Has Abstract

pub_date

2011-07-27 00:00:00

pages

93rv2

issue

93

eissn

1946-6234

issn

1946-6242

pii

3/93/93rv2

journal_volume

3

pub_type

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