The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (CBER) is responsible for regulating vaccine use in the United States.
The general stages of vaccine development are:
- Research and Discovery
- Proof of Concept
- Testing the Vaccine
- The Manufacturing Process
- Approving the Vaccine
- Recommending the Vaccine for Use
- Monitoring Safety After Approval
Research and Discovery
In this early stage of vaccine development, researchers explore their idea for a potential vaccine. Vaccine development often takes 10-15 years of laboratory research, usually at a company in private industry, but often involves collaboration with researchers at a university.
Proof of Concept
Before a vaccine can be tested in people, researchers study its ability to cause an immune response with small animals, like mice. At this stage, researchers may make adjustments to the vaccine to make it more effective. Vaccine effectiveness is important because it measures how well vaccination protects people against outcomes such as infection, symptomatic illness, hospitalization, and death.
If the vaccine shows promising enough results, it moves forward to clinical trials for testing in people.
Testing the Vaccine
Next, the vaccine enters a clinical development stage, which is also called a clinical trial. To do this, researchers submit an Investigational New Drug (IND) application to FDA, which includes data from animal studies, information on manufacturing technology, and the quality of the vaccine. Vaccine quality is important because it affects how well it will work to provide long- and short-term protection against disease. The clinical development stage is a three-phase process, which may include a fourth phase if the vaccine is approved by FDA.
The following is one of the sources where on-going clinical trials on vaccines can be found: https://clinicaltrials.gov/search?cond=Vaccines
