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