Assuring the Quality of Vaccines: Regulatory Requirements for Licensing and Batch Release

Ensuring the consistent safety and efficacy of a vaccine has long been recognized as an essential element in a successful disease-control program. Indeed, the development of appropriate laboratory methods to characterize a vaccine with respect to its component antigens, safety, and potency must be a prerequisite to the routine clinical use of any new bacterial, viral, or antiparasite vaccines, Adequate control measures serve to safeguard vaccinees both against unacceptable adverse effects and inadequate protection.