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Every authorized or approved vaccine goes through safety testing, including:
Vaccines are tested before they’re recommended for use
Before a vaccine is ever recommended for use, it’s tested in labs. This process can take several years. FDA uses the information from these tests to decide whether to test the vaccine with people.
During a clinical trial, a vaccine is tested on people who volunteer to get vaccinated. Clinical trials usually start with 20 to 100 volunteers, but eventually include thousands of volunteers. These tests can take several years and answer important questions like:
Throughout the process, FDA works closely with the company producing the vaccine to evaluate the vaccine’s safety and effectiveness. All safety concerns must be addressed before FDA licenses or authorizes a vaccine.
Every batch of vaccines is tested for quality and safety
Once a vaccine is approved or authorized, it continues to be tested. The company that makes the vaccine tests batches to make sure the vaccine is:
FDA reviews the results of these tests and inspects the factories where the vaccine is made. This helps make sure the vaccines meet standards for both quality and safety.