August 23, 2021

FDA Approves First COVID-19 Vaccine

Nurse in foreground prepares a syringe, patient, out of focus in background waits to get vaccinated.

This post was updated Aug. 23, 2021

Medically reviewed by Baptist Health

The Food and Drug Administration (FDA) has officially approved the Pfizer COVID-19 vaccine, making it the first COVID-19 vaccine to receive full FDA approval.

This is the first COVID-19 vaccine to have completed a full review by the regulatory agency, offering added legitimacy and putting it in the same category as other widely marketed and accepted vaccines.

“The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older,” the FDA said in its announcement on Monday.

Don’t take a chance with your health.

Getting the COVID-19 vaccine is the best way to prevent COVID-19 infection and end the pandemic. The vaccine cannot give you COVID-19, but it can help protect you from serious illness. Learn more about the COVID-19 vaccine and make a vaccination appointment at a location near you. 

The Pfizer/BioNTech COVID-19 vaccine was authorized for emergency use in the United States in December 2020 for those 16 and older. In May 2021, that emergency use authorization was expanded to include those 12 and older. 

“The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals,” according to the FDA.

Full FDA approval could encourage more people to get vaccinated.

A recent poll from the Kaiser Family Foundation found that 31% of unvaccinated people said they would be more likely to get a COVID-19 vaccine once full FDA approval is granted.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” acting FDA Commissioner Janet Woodcock said in a statement. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

The FDA’s full approval of the Pfizer COVID-19 vaccine applies to those 16 years and older. Children ages 12-15 can still receive the vaccine under the emergency use authorization granted last December. 

The Moderna COVID-19 vaccine remains under FDA review for people ages 18 and older, and is expected to receive full approval in the near future. Johnson & Johnson has not yet applied for full FDA approval of its COVID-19 vaccine. 

Protect Yourself Against Serious Infection by Getting Vaccinated

To learn more about COVID-19, visit the Baptist Health COVID-19 Resources page. Getting vaccinated is the best way to protect yourself from serious illness related to COVID-19. Learn more about COVID-19 vaccines and schedule your first dose vaccination appointment today.

Next Steps and Useful Resources:

Start Your COVID-19 Test Online
Schedule Your Vaccine Appointment
Coronavirus Vaccine: EUA vs. FDA Approval
My Why: Vaccine Testimonies from the Frontline
Delta Variant FAQ

Learn More.