Vaccine Safety: An examination of the value and necessity of Phase III trials

Abstract

Phase III trials of vaccines may be holding back the benefits of, and increasing the costs of vaccines, to an extent that is harmful to society. The safety of a vaccine is assessed, in the main, in Phases I and II trials. Were Phase III trials to be rendered unnecessary, it would be desirable to more extensively and stringently examine the performance of the vaccine in the field as part of a post licensure Phase IV exercise. The acceptance of such costs (risk of disbenefit * the magnitude of the disbenefit) is discussed in relation to costs that are commonly incurred while engaged in a modern 21st century life.