The following is a table showing the difference between the classical and emergency vaccination development phases. This information is taken from https://www.sciencedirect.com/science/article/pii/S1876034120307814.
Please read the CARM disclaimer about this information.
Classical Vaccination Phases |
Emergency Pandemics Vaccination Phases |
Preclinical Stage of Vaccination About 18-30 months |
Preclinical State of Vaccination 0 Months |
Phase 1 Dozens of Clinical Trials More than 30 Months |
Phase 1 Dozens of Clinical Trials About 6 Months |
Phase 2 Hundreds of Clinical Trials More than 32 Months |
Phase 2 Hundreds of Clinical Trials About 6 Months |
Phase 3 Thousands of Clinical Trials More than 30 Months |
Phase 3 Thousands of Clinical Trials 0 Months |
Phase 4 Approval, Manufacture From 12 to 24 Months |
Phase 4 Approval, Manufacture Billions of Individual/Doses 6 Months |
Phases Evaluation | Actions |
Phase 1 | In a small number of closely monitored subjects, immunogenicity and safety studies performed. |
---|---|
Phase 2 | Enroll hundreds of subjects and do dose-ranging studies. |
Phase 3 | Provide critical documentation about important and effectiveness additional safety data required for licensing by enrolling thousands of people |