Indication & Authorized Use
Indication
COMIRNATY® (COVID-19 Vaccine, mRNA) is a vaccine indicated for active immunization to prevent coronavirus disease 2019
Interchangeability
When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.
Because of the potential for vaccine administration errors, including dosing errors, COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.
For vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.
Authorized Use
COMIRNATY® (
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a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
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a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA) -
a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved
COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination -
a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved
COVID-19 vaccine -
a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved
COVID-19 vaccine
The Pfizer-BioNTech
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a 3-dose 3 mcg modRNA primary series to individuals 6 months through 4 years of age
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a 2-dose 10 mcg modRNA primary series to individuals 5 through 11 years of age
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a 2-dose 30 mcg modRNA primary series to individuals 12 years of age and older
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a third 10 mcg modRNA primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise
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a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
-
a single 10 mcg modRNA booster dose to individuals 5 through 11 years of age who have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine -
a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with
Pfizer-BioNTech COVID-19 Vaccine or
COMIRNATY® (COVID-19 Vaccine, mRNA) -
a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination
-
a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved
COVID-19 vaccine -
a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine