#CHE VOLUME SERIAL KEY SERIES#
The Pfizer-BioNTech COVID-19 Vaccine is administered as a primary series of 2 doses (0.3 mL each) 3 weeks apart in individuals 12 years of age or older.Ī third primary series dose of the Pfizer-BioNTech COVID-19 Vaccine (0.3 mL) at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age with certain kinds of immunocompromise. The Pfizer-BioNTech COVID-19 Vaccine is a suspension for intramuscular injection. See " MANDATORY REQUIREMENTS FOR PFIZER-BIONTECH COVID-19 VACCINE ADMINISTRATION UNDER EMERGENCY USE AUTHORIZATION" for reporting requirements.
Vaccination providers enrolled in the federal COVID-19 Vaccination Program must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine. SUMMARY OF INSTRUCTIONS FOR COVID-19 VACCINATION PROVIDERS
2ĬOMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 6 months through 11 years of age because of the potential for vaccine administration errors, including dosing errors. 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 when prepared according to their respective instructions for use can be used interchangeably. 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. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. 1ĬOMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer for BioNTech that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.a 2-dose primary series to individuals 12 years of age and older and.Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap is authorized for use to provide: This Fact Sheet pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a purple cap, which is authorized for use in individuals 12 years of age and older and MUST BE DILUTED PRIOR TO USE. The formulation supplied in a multiple dose vial with a gray cap and label with a gray border IS NOT DILUTED PRIOR TO USE. There are 2 formulations of Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 12 years of age and older: The formulation supplied in a multiple dose vial with a purple cap MUST BE DILUTED PRIOR TO USE. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) to permit the emergency use of the unapproved product, Pfizer-BioNTech COVID-19 Vaccine, for active immunization to prevent COVID-19 in individuals 6 months of age and older. FACT SHEET FOR HEALTHCARE PROVIDERS ADMINISTERING VACCINE (VACCINATION PROVIDERS)ĮMERGENCY USE AUTHORIZATION (EUA) OF THE PFIZER-BIONTECH COVID-19 VACCINE TO PREVENT CORONAVIRUS DISEASE 2019 (COVID-19) PRIMARY SERIES FOR 12 YEARS OF AGE AND OLDER
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