- Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap.
Pfizer and BioNTech; March 29, 2022. - Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap.
Pfizer and BioNTech; March 29, 2022.
Indication
COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019
Interchangeability
The FDA-approved COMIRNATY®
Authorized Use
COMIRNATY®
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a 2-dose 30 mcg modRNA primary series to individuals 12 through 15 years of age
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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)
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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
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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; and
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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 COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to provide:
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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 who have been determined to have 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
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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)
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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
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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; and
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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