Pfizer-BioNTech COVID-19 Vaccine, Multiple Dose Vial with Purple Cap Age Rangeĭilute with 1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to useĭuring storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.Ĭartons of Pfizer-BioNTech COVID-19 Vaccine multiple dose vials with purple caps arrive in thermal containers with dry ice. The storage, preparation, and administration information in this Fact Sheet apply to the Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, which is supplied in a multiple dose vial with a purple cap and MUST BE DILUTED before use. Symptoms may include: fever or chills cough shortness of breath fatigue muscle or body aches headache new loss of taste or smell sore throat congestion or runny nose nausea or vomiting diarrhea. Symptoms may appear 2 to 14 days after exposure to the virus. People with COVID-19 have reported a wide range of symptoms, ranging from mild symptoms to severe illness. It is predominantly a respiratory illness that can affect other organs. For the most recent Fact Sheet, please see For information on clinical trials that are testing the use of the Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent COVID-19, please see DESCRIPTION OF COVID-19Ĭoronavirus disease 2019 (COVID-19) is an infectious disease caused by the novel coronavirus, SARS-CoV-2, that appeared in late 2019. See this Fact Sheet for instructions for preparation and administration. 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. PRIMARY SERIES FOR 12 YEARS 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)
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