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EUA Fact Sheets for Vaccination Providers
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6 months through 4 years of age
Pfizer-BioNTech COVID-19 Vaccine for children 6 months through 4 years of age cannot be used for individuals 5 years of age and older.
Primary Series
Vaccine is administered as a primary series of 3 doses as follows:
0.2 mL Intramuscular Injection
3 weeks after the first dose
0.2 mL Intramuscular Injection
at least 8 weeks after the second dose
0.2 mL Intramuscular Injection
Pfizer-BioNTech COVID-19 Vaccine that is supplied in vials with purple, gray, or orange caps, Pfizer-BioNTech COVID-19 Vaccine, Bivalent that is supplied in vials with gray caps, and Pfizer-BioNTech COVID-19 Vaccine, Bivalent that is supplied in vials with orange caps should not be used for individuals 6 months through 4 years of age because of the potential for vaccine administration errors, including dosing errors.
The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a maroon cap and a label with a maroon border contains a volume of 0.4 mL, and is supplied as a frozen suspension that does not contain preservative
Each vial must be thawed before dilution
Vials may be thawed in the refrigerator (2°C to 8°C) or at room temperature (up to 25°C)
Refer to thawing instructions in the panels below
Dilution
Dilute the vial contents using 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine
ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 2.2 mL of diluent
After dilution, 1 vial contains 10 doses of 0.2 mL
Pfizer-BioNTech COVID-19 Vaccine Vial with Maroon Cap and Label with Maroon Border – VIAL VERIFICATION
THAWING PRIOR TO DILUTION
Thaw vial(s) of the vaccine before use either by:
DILUTION
WITHDRAWAL OF INDIVIDUAL 0.2 mL DOSES
Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be a white to off-white suspension. During the visual inspection,
Verify the final dosing volume of 0.2 mL
Confirm there are no particulates and that no discoloration is observed
Do not administer if vaccine is discolored or contains particulate matter
Administer the vaccine intramuscularly.
After dilution, vials of Pfizer-BioNTech COVID-19 Vaccine with maroon caps and labels with maroon borders contain 10 doses of 0.2 mL of vaccine. Low dead volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:
Each dose must contain 0.2 mL of vaccine
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and content
Do not pool excess vaccine from multiple vials
Contact Pfizermedicalinformation.com
EUA Fact Sheet Updates
Please be aware that Pfizer-BioNTech COVID-19 Vaccine is now available in 6 formulations. For additional information on differences across age groups and formulations, please see Vaccine Formulations Guide on the home page of this website.
Label Update: Effective 22 December 2022
Updated shelf life for all formulations. Please see the Shelf Life & Storage page of this website for more information.
Available data supporting transportation of thawed vials increased up to 48 hours.
Click below to view:
• EUA Fact Sheet for Vaccination Providers - 12 years of age and older Dilute Before Use, Purple Cap
• EUA Fact Sheet for Vaccination Providers - 12 years of age and older Do Not Dilute, Gray Cap
• EUA Fact Sheet for Vaccination Providers - 12 years of age and older Do Not Dilute, Bivalent (Original and Omicron BA.4/BA.5), Gray Cap
• EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Orange Cap
• EUA Fact Sheet for Vaccination Providers - 5 through 11 years of age Dilute Before Use, Bivalent (Original and Omicron BA.4/BA.5), Orange Cap
• EUA Fact Sheet for Vaccination Providers - 6 months through 4 years of age Dilute Before Use, Maroon Cap
For healthcare professionals only