The approval process for vaccines is arduous and involves the following steps:
- Preclinical: Laboratory and animal testing to determine potential use in humans.
- IND (Investigational New Drug) Application: Submission of R&D and preclinical data to the FDA for review and initiation of human trials.
- Phase 1: Generally, a small trial conducted in 20-100 healthy people to determine safety, dosage, and immune response.
- Phase 2: Mid-range trial conducted in several hundred people to assess dose-response and adverse events associated with the vaccine.
- Phase 3: Large RCT (Randomized Controlled Trial) involving thousands of people to assess efficacy (does the vaccine work under ideal conditions?) and safety (does the vaccine cause harm?) versus a placebo.
- BLA (Biologics Licensing Application): Comprehensive submission of all preclinical and clinical data to the FDA for review. There is no timeline for approval. In emergency situations like the COVID-19 pandemic, approval may be granted under an EUA (Emergency Use Authorization).
- Phase 4: Post-approval oversight and ongoing monitoring that may require post-marketing studies to further assess known or potential serious risks. Vaccines are closely monitored using multiple surveillance systems including: VAERS (Vaccine Adverse Event Reporting System), BEST (Biologics Effectiveness and Safety) program, the FDA Sentinel Program, the FDA and CMS (Centers for Medicare & Medicaid Services) partnership program, the V-Safe phone app, and the CDC Vaccine Safety Datalink.