Assuring the Quality and Safety of Vaccines: Regulatory Expectations 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 against both unacceptable adverse events and inadequate protection.