Updated Oct. 28, 2022
Millions of people in the United States have received COVID-19 vaccines, which are continuously monitored for safety by the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA). The Pfizer-BioNTech, Moderna, Johnson & Johnson Janssen, and Novavax COVID-19 vaccines have all undergone Phase III clinical trials conducted worldwide and have received emergency use authorizations (EUA) from the FDA for use in the prevention of COVID-19 in the United States. The Pfizer and Moderna vaccines may be used in individuals as young as 6 months. The Novavax vaccine is authorized for use in individuals 12 and older. The Johnson & Johnson vaccine is authorized for use in individuals 18 and older.
The Pfizer-BioNTech and Moderna COVID-19 vaccines have received full FDA approval for use in individuals 16 and older and 18 and older, respectively. FDA approval for both vaccines was followed by an independent review by the CDC Advisory Committee on Immunization Practices (ACIP), which provided its recommendations for use of the vaccines. The Pfizer-BioNTech vaccine is marketed as Comirnaty (koe-mir’-na-tee) for use in the prevention of COVID-19 in individuals 16 and older. The Moderna vaccine is marketed as Spikevax for use in the prevention of COVID-19 in individuals ages 18 and older.
The Pfizer-BioNTech vaccine is available to youth 6 months to 15 years under its emergency use authorization and labeled as Pfizer-BioNTech. The Moderna vaccine is available for youth 6 months to 17 years under emergency use authorization and labeled as Moderna. The vaccines are labeled as such because the vaccines are authorized and not yet approved for individuals in those age ranges.
NOTE: CDC recommends that people who are starting their vaccine series or getting a booster dose get either Pfizer-BioNTech or Moderna (mRNA COVID-19 vaccines) or the Novavax vaccine. The Novavax and mRNA vaccines are preferred over Johnson & Johnson’s Janssen COVID-19 vaccine in most circumstances. Learn more
Additionally, the Novavax vaccine is recommended for individuals who have not yet received any of the COVID-19 vaccines. Additional doses of the Novavax vaccine are not authorized for individuals with compromised immune systems.
Data Collection and Review
Vaccine makers are required to track any adverse reactions that vaccine clinical trial participants have. To do this for the COVID-19 vaccines, they collected data on thousands of participants for at least one month after both doses to ensure that they hadn’t had any unexpected reactions to the vaccine. The FDA next reviewed all data from the clinical trials before granting EUA for each vaccine.
Once EUA was granted, the federal Advisory Committee on Immunization Practices (ACIP) met to review the vaccines and determine whether or not they could safely recommend the vaccines and for which populations. Once ACIP recommended each COVID-19 vaccine (and later, boosters for each vaccine), they were next reviewed by the Western States Scientific Safety Review Workgroup, which reviews the vaccines to ensure their safety before they are used in Washington, Oregon, Nevada, Colorado and California. The Scientific Safety Review Workgroup includes Washington, Oregon, Nevada, Colorado and California; panel members include nationally recognized experts appointed by each of the member states. Learn more
For more information, see our Vaccine FAQ and Vaccine Development. Other information provided on the Resources tab above.
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