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    Every authorized or approved vaccine goes through safety testing, including:

    • Testing and evaluation of the vaccine before it’s licensed by the Food and Drug Administration (FDA) and recommended for use by the Centers for Disease Control and Prevention (CDC)
    • Monitoring the vaccine’s safety after it is recommended for infants, children, or adults

    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:

    • Is the vaccine safe?
    • What dose (amount) works best?
    • How does the immune system react to it?

    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:

    • Potent (It works like it’s supposed to)
    • Pure (Certain ingredients used during production have been removed)
    • Sterile (It doesn’t have any outside germs)

    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.

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