Potential use of inflammation and early immunological event biomarkers in assessing vaccine safety

Abstract

Highly effective vaccines have traditionally been designed in a rather empirical way, often with incomplete understanding of their mode of action. Full assessment of efficacy and reactogenicity takes time and, as a result, vaccine introduction to the market is usually slow and expensive. In addition, in rare cases, unacceptable reactogenicity may only become apparent after years of development or even widespread use. However, recent advances in cell biology and immunology offer a range of new technologies and systems for identifying biological responses or " biomarkers" that could possibly be used to evaluate and predict efficacy and safety during vaccine development and post-marketing surve..