Pfizer Emergency Use Authorization and FDA Approval
An Emergency Use Authorization (EUA) for Pfizer-BioNTech COVID-19 Vaccine was issued by the Food and Drug Administration (FDA) on December 11, 2020.
FDA granted full approval for:
- Primary (2-dose) series for persons 16 years of age and older on August 23, 2021
- Primary (2-dose) series for persons 12 – 15 years of age on July 8, 2022
An EUA allows access to critical medial products that may help during a public health emergency. EUAs differ from approval/licensure in they are authorized to use for a serious or life-threatening disease or condition and there is no adequate FDA-approved alternative. Approval/licensure means vaccines have received full approval for use after additional data has been reviewed.
The COMIRNATY Vaccine is available under approval/licensure for a primary (2-dose) series for people 12 years of age and older.
The Pfizer-BioNTech Vaccine is available under EUA for people:
- 6 months through 4 years of age for a primary 3-dose series
- 5 through 11 years of age for a primary 2-dose series
- 5 years of age and older who are moderately or severely immunocompromised for an additional primary (3rd) dose
- 5 years of age and older for a booster dose
- 12years of age and older who are moderately or severely immunocompromised for a 2nd booster dose
- 50 years of age and older for a 2nd booster dose