Stages | Processes |
Exploratory Stage | ・ Basic laboratory research (~2 - 4 years) ・ Identify natural or synthetic antigens with possibility to prevent or treat a disease ・ Examples of antigens: virus-like particles, weakened viruses or bacteria, weakened bacterial toxins, or other substances derived from pathogens |
Pre-clinical Stage | ・ Tissue-culture/cell-culture systems and animal testing (~1 - 2 years) ・ Assess safety and immunogenicity, or ability to provoke an immune response |
IND Application | ・ Investigational New Drug (IND) submitted to the FDA ・ Describes the manufacturing and testing processes, summarizes the laboratory reports and describes the proposed study |
Phase I | ・ Vaccine administered to healthy humans (small sample size <100) ・ Assess vaccine safety & immunogenicity |
Phase II | ・ Vaccine administered to humans (moderate sample size 100 - 1000)―effect of gender, age, and ethnicity assessed ・ Assess vaccine’s safety, immunogenicity, proposed doses, schedule of immunizations and method of delivery |
Phase III | ・ Vaccineadministered to humans (large sample size 1000 - 10,000) ・ Randomized, double blind and involve the experimental vaccine being tested against a placebo ・ Assess the efficacy and adverse reactions of the vaccine |
Approval and Licensure | ・ Submit Biologics License Application (BLA) to FDA ・ Inspection of vaccine development factory and approve the labelling of vaccine ・ After licensure, FDA continues to monitor the production of the vaccine: inspecting facilities and reviewing the manufacturer’s tests for potency, safety and purity of vaccines |
Phase IV | ・ Optional studies by companies conducted after a vaccine is released ・ Continue to test the vaccine for safety, efficacy, and other potential uses |