FDA Approval, Explained
How FDA approval differs from Emergency Use Authorization.
Published
The Pfizer-BioNTech vaccine has full FDA approval as of August 23. FDA previously granted emergency use authorization on December 11, 2020, for individuals ages 16 and older, and on May 10, 2020, expanded that EUA to include those ages 12–15. (Source.)
So, what’s changed now that the vaccine has full FDA approval for individuals 16 and older?
| Emergency Use Authorization | Full Approval/Licensure | |
|---|---|---|
| Use is permitted during a declared emergency, such as the COVID-19 pandemic. | ✓ |
✓ |
| Use is permitted even when there is no public health emergency. | ✓ | |
| Physicians can prescribe the vaccine “off-label,” for specific purposes (although such use is generally not recommended at this time). | ✓ | |
| The manufacturer can market the product to health care providers and the public, subject to applicable laws and regulations. | ✓ | |
| Vaccine mandates are possible in states where laws prohibit mandating vaccines authorized only for emergency use. | ✓ |
