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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, Bivalent for individuals 12 years of age and older is indicated for a booster dose only and cannot be used for children 6 months through 11 years of age. A different presentation of Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in multiple dose vials with orange caps and labels with orange borders is available for use in individuals 5 through 11 years of age.
Booster Dose
EITHER
Individuals 12 Years of Age and OlderSINGLE BOOSTER DOSE
At least 2 months after completion of primary vaccination with any authorised or approved COVID-19 vaccine
0.3 mL Intramuscular Injection
OR
Individuals 12 Years of Age and OlderSINGLE BOOSTER DOSE
At least 2 months after receipt of the most recent booster dose with any authorised or approved monovalent* COVID-19 vaccine
0.3 mL Intramuscular Injection
*Monovalent refers to any authorised or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent Vial with Gray Cap and Label with Gray Border – VIAL VERIFICATION
Verify that the vial of Pfizer-BioNTech COVID-19 Vaccine, Bivalent:
has a gray cap and a label with a gray border
states Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)
THAWING PRIOR TO USE
Allowing vial(s) to thaw in the refrigerator (2°C to 8°C)
A carton of 10 single dose vials may take up to 2 hours to thaw
A carton of 10 multiple dose vials may take up to 6 hours to thaw
Allowing vial(s) to sit at room temperature (up to 25°C) for 30 minutes
PREPARATION OF INDIVIDUAL 0.3 mL DOSES
Single Dose Vial
Withdraw a single 0.3 mL dose of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent
Administer immediately
Discard vial and any excess volume
Multiple Dose Vial
Multiple dose vials contain 6 doses of 0.3 mL each
Withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent preferentially using low dead volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial
Administer immediately
If the amount of vaccine remaining in a multiple dose vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
Multiple Dose Vial - Record Date and Time of First Puncture
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The vaccine will be a white to off-white suspension. Do not administer if vaccine is discolored or contains particulate matter.
After withdrawing a single 0.3 mL dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent, administer immediately.
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