New Method of Vaccine Safety Evaluation?

[SaneVax: Is there a new method available to evaluate vaccine safety? To date vaccine safety in the United States has been monitored via a voluntary adverse event reporting system. There is no penalty assessed against medical professionals who fail to recognize and/or report vaccine injuries. Vaccine injuries do occur. Those at risk deserve to be identified, quantified and excluded from vaccination programs. Nothing less is acceptable.]

A New Method for the Evaluation of Vaccine Safety Based on Comprehensive Gene Expression Analysis

1Department of Safety Research on Blood and Biological Products, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan
2Division of Quality Assurance, National Institute of Infectious Diseases, 4-7-1 Gakuen, Musashimurayama, Tokyo 208-0011, Japan

Received 30 September 2009; Accepted 2 April 2010

Academic Editor: Yongqun Oliver He

Copyright © 2010 Haruka Momose et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


For the past 50 years, quality control and safety tests have been used to evaluate vaccine safety. However, conventional animal safety tests need to be improved in several aspects. For example, the number of test animals used needs to be reduced and the test period shortened. It is, therefore, necessary to develop a new vaccine evaluation system. In this review, we show that gene expression patterns are well correlated to biological responses in vaccinated rats. Our findings and methods using experimental biology and genome science provide an important means of assessment for vaccine toxicity.

1. Introduction

Vaccination effectively enables the control of many infectious diseases. However, we cannot always avoid the problem of adverse reactions accompanied by vaccination. While most adverse reactions are mild and local, some vaccines have been associated with very rare but severe systemic reactions. Therefore, all vaccines for public use are made in compliance with Good Manufacturing Practices (GMP) to prevent safety problems. Furthermore, manufacturers must submit samples and results of their in-house tests for each vaccine batch to the national control authorities before vaccines are released into the market. Among many quality control tests, conventional animal safety tests are performed to detect vaccine toxicity because residual vaccine toxicity has the potential to cause adverse reactions. For example, the animal body weight change test is the most commonly used test to evaluate the toxicity of vaccines [1]. Although a good correlation of the body weight loss with a vaccine’s toxicity has been shown [23], a greater understanding of the molecular mechanisms involved in the reaction to a vaccines’ toxicity is needed. We, therefore, attempted to measure animals’ responses to vaccines by determining changes in gene expression profiles.

Gene expression profiling is a unique way to characterize how cells or tissues are affected by abnormal conditions. The measurement of gene expression levels upon exposure to toxicants can be used to identify toxic products, and to provide information about the mechanism of toxicity [4]. DNA microarray technology has opened the way for the parallel detection and analysis of expression patterns of thousands of genes in a single experiment. Furthermore, the development of high-quality gene arrays has allowed DNA microarray technology to become a standard tool in molecular toxicology. Recently, the field of toxicogenomics has validated the concept of gene expression profiles as “signatures” of toxicant classes [57]. These signatures have effectively directed the analytical search for predictive toxicant biomarkers and they have contributed to the understanding of the dynamic responses of molecular mechanisms associated with toxic responses. In fact, many studies of gene-expression profiles have now been reported in the toxicology field. For example, Hamadeh et al. reported patterns of gene expression in liver tissue taken from rats exposed to different chemicals [8]. DNA microarray assays have also been applied to the analysis of the side effects of medicines [9]. Recently, the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) have, either individually or together, started to review submissions for the qualification of biomarkers for medical products for specific purposes proposed by industry [10]. The introduction of pharmacogenomics, or pharmacogenetics, to the evaluation of medicines is a global trend.

For a better understanding of the molecular toxicology regarding vaccines, DNA microarray analysis promises to be an ideal method, as has been the case for pharmaceuticals.

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