Any decision made to extend the dating period of a vaccine is predicated and sustained by the data submitted by the manufacturer that verifies the sterility and potency of the product. Because of the complex manufacturing process for most biological products, each lot undergoes thorough testing by the manufacturer. The manufacturer performs specific tests as specified in their license application. The manufacturer submits samples of each licensed vaccine lot and the results of their own tests for potency, safety, and sterility to the Agency. The manufacturer may not distribute a lot of the product into interstate commerce until CBER releases it.
All vaccines are subject to lot release.
The lot release program is part of FDA s multi-part strategy that helps assure biological product safety by providing a quality control check on product specifications. Any event set forth in the Reportable Events Table that occurs within the time period specified. Any event listed in the manufacturer's package insert as a contraindication to subsequent doses of the vaccine. There are no penalties specified in the law for health care providers who do not report adverse events. However, FDA takes active steps to educate physicians, nurses and other health care workers about the importance of reporting adverse vaccine events.