I’m optimistic about … COVID-19 vaccines (part 2).

Vaccine Approval.

 The approval process for vaccines is arduous and involves the following steps:

  1. Preclinical: Laboratory and animal testing to determine potential use in humans.
  2. IND (Investigational New Drug) Application: Submission of R&D and preclinical data to the FDA for review and initiation of human trials.
  3. Phase 1: Generally, a small trial conducted in 20-100 healthy people to determine safety, dosage, and immune response.
  4. Phase 2: Mid-range trial conducted in several hundred people to assess dose-response and adverse events associated with the vaccine.
  5. 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.
  6. 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).
  7. 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.

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