Vaccine Testing and the Approval Process
This page leads to other pages that describe vaccine development and testing such as basic research, clinical studies, side effects and adverse reactions, vaccines of the future, and the vaccine product approval process.
The general stages of the development cycle of a vaccine are:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Quality control
Clinical development is a three-phase process. During Phase I, small groups of people receive the trial vaccine. In Phase II, the clinical study is expanded and vaccine is given to people who have characteristics (such as age and physical health) similar to those for whom the new vaccine is intended. In Phase III, the vaccine is given to thousands of people and tested for efficacy and safety.
Many vaccines undergo Phase IV formal, ongoing studies after the vaccine is approved and licensed.
For more information and to find out about new vaccines on the horizon, see the World Health Organization’s (WHO’s) Development of New VaccinesExternal web page.
The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and ResearchExternal (CBER) is responsible for regulating vaccines in the United States.
The sponsor of a new vaccine product follows a multi-step approval process, which typically includes
- An Investigational New Drug application
- Pre-licensure vaccine clinical trials
- A Biologics License Application (BLA)
- Inspection of the manufacturing facility
- Presentation of findings to FDA’s Vaccines and Related Biological Products Advisory CommitteeExternal (VRBPAC)
- Usability testing of product labeling
After approving a vaccine, FDA continues to oversee its production to ensure continuing safety. Monitoring of the vaccine and of production activities, including periodic facility inspections, must continue as long as the manufacturer holds a license for the vaccine product.
FDA can require a manufacturer submit the results of their own tests for potency, safety, and purity for each vaccine lot. FDA can require each manufacturer submit samples of each vaccine lot for testing.
To learn about FDA’s role in the vaccine approval process, consult FDA’s Vaccine Product Approval ProcessExternal web page.
The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program co-sponsored by the Food and Drug Administration (FDA) and the CDC.
VAERS collects and analyzes information from reports of adverse events (side effects) that occur after the administration of US licensed vaccines. Reports are welcome from all concerned individuals: patients, parents, healthcare providers, pharmacists, and vaccine manufacturers. To submit a report, use VAERS’ reporting pageExternal.
For more information on VAERS, consult VAERS websiteExternal.
- Vaccine Development, Testing and RegulationExternal
Source: History of Vaccines
- Vaccine RegulationExternal
(World Health Organization)
- FDA’s Vaccine Safety & AvailabilityExternal
- Vaccine Adverse Event Reporting SystemExternal (VAERS)
- CDC’s Vaccine Safety