Vaccines: predicting the risk of allergy and autoimmunity

The field of vaccines is markedly evolving with the introduction and development of many new concepts and formulations, as well as new indications. Based on the current clinical experience, vaccines can be considered safe in most cases. Nevertheless, allergy and, to a lesser extent, autoimmunity have repeatedly been described or suspected as rare adverse consequences of human vaccines. The mechanisms of these adverse reactions are ill-elucidated, if at all. No animal models have been adequately standardized and validated to predict the risk of allergy and autoimmunity associated with vaccines. However, a number of existing models can be considered for use, but need refinement to be applied to vaccine evaluation. Finally, because the preclinical safety evaluation has not received much attention in the past, efforts should be paid to design specific and cost-effective procedures to meet the current expectations.