After sufficient safety and efficacy data exist for a new COVID-19 vaccine, which application is required to launch?

After sufficient safety and efficacy data exist for a new COVID-19 vaccine, which application is required to launch?

• A. NDA (New Drug Application)
• B. BLA (Biologics License Application)
• C. PMA (Pre-market Approval)
• D. IND (Investigational New Drug)

Answer: (B)

Vaccines are regulated as biologics, so the step to bring one to market after demonstrating adequate safety and efficacy is a Biologics License Application. This submission to FDA’s Center for Biologics Evaluation and Research compiles all clinical trial data, manufacturing processes, quality controls, and labeling plans. If the FDA finds the benefit–risk profile favorable and the product can be manufactured consistently, the biologic license is granted, allowing marketing of the vaccine. The other pathways don’t fit this stage: an NDA is for non-biologic drugs, PMA is for medical devices, and an IND is the preclinical/early-stage authorization required to start human trials, not for final market approval.

Vaccines are regulated as biologics, so the step to bring one to market after demonstrating adequate safety and efficacy is a Biologics License Application. This submission to FDA’s Center for Biologics Evaluation and Research compiles all clinical trial data, manufacturing processes, quality controls, and labeling plans. If the FDA finds the benefit–risk profile favorable and the product can be manufactured consistently, the biologic license is granted, allowing marketing of the vaccine.

The other pathways don’t fit this stage: an NDA is for non-biologic drugs, PMA is for medical devices, and an IND is the preclinical/early-stage authorization required to start human trials, not for final market approval.