FDA grants Pfizer COVID-19 vaccine full approval
On Monday, August 23, the Food and Drug Administration (FDA) granted full approval to Pfizer’s COVID-19 vaccine for individuals 16 or older.
More than 200 million Pfizer doses have been administered in the U.S., but up to now, they were distributed under what is known as emergency use authorization from the FDA.
“Several surveys revealed that unvaccinated individuals would be more willing to consider receiving the COVID-19 vaccine if it received FDA approval,*” said Dr. Darren Wethers, Vice President of Clinical Operations at Blue Cross® Blue Shield® of Arizona. “I hope that this recent action by the FDA will influence more people to get vaccinated as soon as possible.”
The Pfizer vaccine also continues to be available under emergency use authorization for individuals 12 through 15 years of age, and for the administration of a third dose in certain immunocompromised individuals, until the FDA completes its standard review process.
Key Achievement for Public Health
"The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic," Acting FDA Commissioner Janet Woodcock said in a statement. "While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product."
Scientists and medical experts evaluated hundreds of thousands of pages of scientific data and information from 40,000 trial participants, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. The vaccine was found to be 91% effective in preventing COVID-19 in fully vaccinated individuals.
For additional COVID-19 vaccine administration information, please visit cdc.gov or azblue.com/coronavirus.
If you have not yet received the vaccine and would like to, or you are eligible to receive the additional dose, please visit azdhs.gov/findvaccine.
How the Vaccine Works
It’s important to have factual, straightforward information about these vaccines. Watch this 3-minute video to learn how the Pfizer COVID-19 vaccine is made, why it is safe and effective, and how it works with your body to protect you from the coronavirus.
FDA News Release
*Kaiser Family Foundation
Last Updated: 08/24/2021