An annual vaccine: seasonal influenza.
ABSTRACT The accelerated development process for annual vaccines such as seasonal influenza presents unique challenges for the evaluation of vaccine stability. Real-time real-condition studies provide limited information at the time of registration, while regulators seek evidence that the current vaccine will perform satisfactorily in the field. Participants in the IABS Workshop on Stability Evaluation of Vaccines, a Life Cycle Approach, were offered a case study from the development of the 2007 influenza vaccine. The case study was introduced with preliminary data from the long-term study, as well as results from the completed year long study. The manufacturer also offered a proposed protocol for stability evaluation of vaccines developed in subsequent seasons. Participants were asked to answer a series of questions posed by the regulator, and critique the proposed stability protocol according to the principles described during the workshop.