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
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COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine


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Page last reviewed: July 13, 2022