food and drug administration (fda)

How does the vaccine approval process work?

The vaccine approval process involves multiple stages:
Preclinical Research: Laboratory studies and animal testing to gather initial data on safety and efficacy.
Clinical Trials: Human trials conducted in three phases:
Phase 1: Small group of healthy volunteers to assess safety and dosage.
Phase 2: Larger group to evaluate efficacy and side effects.
Phase 3: Thousands of participants to confirm efficacy, monitor side effects, and compare with standard treatments.
FDA Review: Detailed review of all data from clinical trials. This includes inspections of manufacturing facilities.
Post-Market Surveillance: Monitoring of the vaccine’s performance and safety once it is in use.

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