Answer: The regulatory approval pathways are summarized below. The FDA will rely on the Vaccines and Related Biological Products Advisory Committee (VRBPAC) to make recommendations based on its evaluation of safety, efficacy, and appropriate use data available for the COVID-19 vaccine candidates.
Once preclinical and clinical development programs have been successfully completed, companies submit a BLA to the FDA. A BLA is a comprehensive submission which includes preclinical and clinical data and information, as well as details of the manufacturing process and facility(ies). The BLA is the official request for permission to introduce a biologic product, including a vaccine, into interstate commerce.
This allows investigational drugs, biologics, or medical devices that have not yet been approved or cleared by FDA to be used for a patient with an immediately life-threatening condition or serious disease for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Currently, expanded access is one pathway for use of COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible for or who are unable to participate in randomized clinical trials.