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EUA Fact Sheets for Vaccination Providers
EUA Fact Sheets for Recipients
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12 years of age and older
Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older is indicated for primary series only and cannot be used for children 6 months through 11 years of age.
Primary Series
Vaccine is administered as a primary series of 2 doses
0.3 mL Intramuscular Injection
3 weeks after the first dose
0.3 mL Intramuscular Injection
A third primary series dose of the vaccine (0.3 mL) administered at least 28 days following the second dose is authorised for administration to individuals at least 12 years of age with certain kinds of immunocompromise.*
*Certain kinds of immunocompromise refers to individuals who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Each vial MUST BE DILUTED before administering the vaccine.
Prior to Dilution
The Pfizer-BioNTech COVID-19 Vaccine multiple dose vial with a purple cap contains a volume of 0.45 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 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine. Do not add more than 1.8 mL of diluent
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
After dilution, 1 vial contains 6 doses of 0.3 mL
Pfizer‐BioNTech COVID‐19 Vaccine Vial with Purple Cap – VIAL VERIFICATION
THAWING PRIOR TO DILUTION
Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by:
Allowing vial(s) to thaw in the refrigerator (2°C to 8°C). A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month
Allowing vial(s) to sit at room temperature (up to 25°C) for 30 minutes
Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours
Before dilution invert vaccine vial gently 10 times
Do not shake
Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles
Do not use if liquid is discolored or if other particles are observed
DILUTION
Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent
Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle)
Cleanse the vaccine vial stopper with a single-use antiseptic swab
Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial
Gently invert the vial containing the vaccine 10 times to mix
Do not shake
Inspect the vaccine in the vial
The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter
Record the date and time of dilution on the vaccine vial label
Store between 2°C to 25°C
Discard any unused vaccine 6 hours after dilution
WITHDRAWAL OF INDIVIDUAL 0.3 mL DOSES
Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the vaccine preferentially using low dead-volume syringes and/or needles
Each dose must contain 0.3 mL of vaccine
If the amount of vaccine remaining in a single vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
Administer immediately
Verify the final dosing volume of 0.3 mL
Confirm there are no particulates and that no discoloration is observed
Do not administer if vaccine is discolored or contains particulate matter
Each dose must contain 0.3 mL of vaccine
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 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