STAGES OF VACCINE DEVELOPMENT

About:

1. Exploratory: This research-intensive phase of the vaccine development process is designed to identify “natural or synthetic antigens that might help prevent or treat a disease.”
   
   
2. Pre-clinical: During this phase, researchers use tissue-culture or cell-culture systems and animal testing to determine whether the candidate vaccine will produce immunity.
   
   
3. Clinical development: It is a three-phase process.
   1. During Phase I, small groups of people receive the trial vaccine.
      
      
   2. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics similar to those for whom the new vaccine is intended.
      
      
   3. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
      
      
   
   
   
4. Regulatory review and approval: If a vaccine passes through all three phases of clinical development, the vaccine developer submits a Biologics License Application (BLA) to the FDA.
   
   
5. Manufacturing: Major drug manufacturers provide the infrastructure, personnel and equipment necessary to create mass quantities of vaccines.
   
   
6. Quality control: Stakeholders must adhere to procedures that allow them to track whether a vaccine is performing as anticipated.