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 Vaccines web page.
Vaccine Product Approval Process
The U.S. Food and Drug Administration’s (FDA’s) Center for Biologics Evaluation and Research (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 Committee (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 Process web page.
Tracking Side Effects Once a Vaccine is Adminstered
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 page.
For more information on VAERS, consult VAERS website.
Related Topics and Sources
- Vaccine Development, Testing and Regulation
Source: History of Vaccines
- Vaccine Regulation
(World Health Organization)
- FDA's Vaccine Safety & Availability
- Vaccine Adverse Event Reporting System (VAERS)
- CDC’s Vaccine Safety
Images and logos on this website which are trademarked/copyrighted or used with permission of the trademark/copyright or logo holder are not in the public domain. These images and logos have been licensed for or used with permission in the materials provided on this website. The materials in the form presented on this website may be used without seeking further permission. Any other use of trademarked/copyrighted images or logos requires permission from the trademark/copyright holder...more
This graphic notice means that you are leaving an HHS Web site. For more information, please see the Exit Notification and Disclaimer policy.