Pfizer-BioNTech COVID-19 Vaccine
The Pfizer-BioNTech COVID-19 Bivalent Booster Vaccine has not been approved or licensed by FDA, but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older.
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
- FDA Emergency Use Authorization Letter
- EUA Fact Sheet for Providers
- EUA Fact Sheet for Recipients & Caregivers
- Pfizer-BioNTech COVID-19 Vaccine Consent and Screening Form for Individuals Under 18 Years of Age | Spanish | Vietnamese | Japanese
As the vaccination provider, you must communicate to the recipient or their caregiver information consistent with the “Fact Sheet for Recipients and Caregivers” (and provide a copy or direct the individual to the website https://www.cvdvaccine-us.com/ to obtain the Fact Sheet) prior to the individual receiving the COVID-19 vaccine. Information to be communicated includes:
- FDA has authorized the emergency use of the COVID-19 vaccine, which is not an FDA-approved vaccine.
- The recipient or their caregiver has the option to accept or refuse the COVID-19 vaccine.
- The significant known and potential risks and benefits are unknown.
- Information about available alternative vaccines and the risks and benefits of those alternatives.
Adult Dose Pfizer-BioNTech COVID-19 Vaccine Overview
Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with a gray cap and a label with a gray border. This is for adult doses and should not be used in individuals 11 years of age and younger.
Age Indication: 12 years or older
Dose: 0.3 mL
Route: Intramuscular
Schedule: Primary and Booster Series
Dose preparation: Multi-dose; 6 doses per vial | DO NOT MIX with diluent
Adolescent Dose Pfizer-BioNTech COVID-19 Vaccine Overview
Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with a orange cap and a label with a orange border. This is for pediatric doses and should not be used in individuals outside of the 5 – 11 age range.
Age Indication: 5 through 11 years of age
Dose: 0.2 mL
Route: Intramuscular
Schedule: Primary and Booster Series
Dose preparation: Multi-dose; 10 doses per vial | 1.3 mL of diluent
Pediatric Dose Pfizer-BioNTech COVID-19 Vaccine Overview
Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with a maroon cap and a label with a maroon border. This is for pediatric doses and should not be used in individuals outside of the 6 month – 4 age range.
Age Indication: 6 months through 4 years of age
Dose: 0.2 mL
Route: Intramuscular
Schedule: Primary and Booster Series
Dose preparation: Multi-dose; 10 doses per vial | 2.2 mL of diluent
Pfizer-BioNTech & COMIRNATY COVID-19 Storage and Handling
Vial Storage Prior To Use
Ultra-Low-Temperature (ULT) Freezer
-90°C to -60°C | -130°F to -76°F
- Remove vial trays immediately from the shipper, then transfer to an ultra-low temperature freezer.
- Unopened vials: Up to 6 months
Freezer
DO NOT STORE IN FREEZER
Refrigerator
2°C to 8°C | 36°F to 46°F
- Unopened vials: store up to 10 weeks
- Punctured vials: viable up to 12 hours
Vial Storage During Use
Thawing Frozen Vials
Up to 25°C | Up to 77°F
- A carton 25 vials or 195 vials may take 2-3 hours to thaw
- Fewer number of vials will thaw in less time
- Unopened vials: viable up to 12 hours
- Punctured vial: viable up to 12 hours after once punctured
Thawed vaccine CANNOT be refrozen.
Vial Expiration Date Look Up
You must look up the expiration date for the Pfizer-BioNTech vaccine through their Look Up Vial Expiration Date tool.
- Go to lotexpiry.cvdvaccine.com. The expiration date tool will display.
- Enter your lot number, printed on the carton and vial on the vaccine, in the Enter Lot # field.
- Click Submit. The expiration date will display.
- Key in the expiration date in LINKS.
For more information or to view LINKS training videos, visit lalink.org.
Temperature Excursions for Pfizer-BioNTechIn the event of a temperature excursion, contact Pfizer-BioNTech:
Phone: (800) 666-7248 Email: [email protected]