On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and the approved vaccine is marketed as Comirnaty, for the prevention of COVID-19 in individuals 12 years of age and older. 

Comirnaty is a monovalent COVID-19 vaccine that is approved for use as a two-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. 

Pfizer-BioNTech COVID-19 Vaccine is a monovalent COVID-19 vaccine that is authorized for emergency use to prevent COVID-19 as: 

• The first two doses of the three-dose primary series for children 6 months through 4 years of age. 
• A two-dose primary series for individuals 5 years of age and older. 
• A third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise. 

Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for emergency use to prevent COVID-19 as:

• The third dose of the three-dose primary series following two doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine in children 6 months through 4 years of age. 
• A single booster dose at least two months after completion of either primary vaccination with any authorized or approved COVID-19 vaccine or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine in individuals 5 years of age and older.

 

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Comirnaty Information

 

Pfizer-BioNTech Fact Sheets (English) and FAQs

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