Updated Sept. 21, 2021
The Pfizer-BioNTech, Moderna, and Johnson & Johnson Janssen Biotech COVID-19 vaccines have all undergone Phase III clinical trials conducted worldwide with almost 120,000 volunteers and have received emergency use authorizations (EUA) from the Food and Drug Administration (FDA) for use in the prevention of COVID-19 in the United States.
In addition, on Aug. 23, 2021, the FDA approved the Pfizer-BioNTech COVID-19 vaccine for use in individuals 16 years and older for the prevention of COVID-19. It is the first COVID-19 vaccine to receive full approval. FDA approval was followed by an independent review by the CDC Advisory Committee on Immunization Practices (ACIP), which subsequently provided its recommendation for use of the vaccine. The vaccine will now be marketed as Comirnaty (koe-mir’-na-tee). The vaccine is still available for use in individuals ages 12-15 under its previous EUA.
Data Collection and Review
Vaccine makers are required to track any adverse reactions that vaccine trial participants have. To do this for the COVID-19 vaccines, they have collected data on thousands of participants for at least one month after both doses to ensure that they haven’t had any unexpected reactions to the vaccine.
The vaccines are then reviewed by the federal advisory committee, ACIP and the FDA’s Vaccines and Related Biological Products Advisory Committee, a group of infectious disease, pediatric and vaccine medical experts, who will only grant an EUA to use a vaccine that has demonstrated quality and safety during clinical trials.
Before they can be used in Washington state, the vaccines must also be 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
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