Final answer:
VAERS is administered by the CDC and FDA and is used to detect safety issues with U.S.-licensed vaccines. Sponsors must report adverse events to the FDA post-NDA approval, with serious events requiring reporting within 15 days.
Step-by-step explanation:
The Vaccine Adverse Event Reporting System (VAERS) is administered by the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). VAERS is a national early warning system to detect possible safety problems in U.S.-licensed vaccines. By collecting and analyzing information from reports of adverse events following vaccination, VAERS helps ensure that the vaccines are as safe as possible. After obtaining the New Drug Application (NDA) approval, the sponsor must review and report every patient adverse drug experience to the FDA. Serious and fatal adverse events must be reported within 15 days, while other events are reported on a quarterly basis. MedWatch, another FDA program, also collects voluntary reports of adverse drug events directly.