Once the vaccine sponsor believes it has generated sufficient data to meet FDA’s safety and effectiveness requirements, the sponsor can submit a Biologics License Application (BLA) or request for an Emergency Use Authorization (EUA)(when appropriate) to FDA. This session will describe these procedures, as well as the rigorous process FDA uses to review the data in consultation with the Vaccines and Related Biological Products Advisory Committee (VRBPAC). We will also discuss other considerations such as the role of other government entities and post-approval pharmacovigilance. The illustration of COVID-19 vaccines in relation to this process will also be discussed.
- BLA Standard
- EUA Standard
- Role and Process of VRBPACVa
- Role of Other Government Entities
- Post-Approval Pharmacovigilance
Colleen M. Heisey, Partner, Jones Day
This session was recorded as part of FDLI’s Virtual Fundamentals of Vaccine Regulation Course in February 2021.