Adolescent Pfizer-BioNTech COVID-19 Vaccine

The U.S. 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 5 years of age and older.

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.

Adolescent Dose of Pfizer-BioNTech COVID-19 Vaccine Overview

Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with an orange cap and a label with an orange border. This is for adolescent doses and should not be used in individuals 12 years of age and older. 

Age Indication: 5 to 11 years of age

Dose: 0.2 mL

Route: Intramuscular

Schedule: 0, 21 days

Dose Preparation: Multi-dose; 10 doses per vial | Reconstitute with dilute (1.3 mL sterile 0.9% Sodium Chloride Injection, USP prior to use) 

Adolescent Pfizer-BioNTech COVID-19 Vaccine Storage and Handling

Vial Storage Prior to Use 

Ultra-Low-Temperature (ULT) Freezer

-90°C and -60°C | -130°F and -76°F
  • Store vaccine vials upright in the tray or box.
  • Protect from light.
  • Vaccine may be stored until the expiration date. Vaccine expires 6 months after the manufacture date.
    • The manufacture date is printed on the vial (orange cap)
    • Count out 6 months, using the month printed on the vial as month 1.
  • The vaccine expires on the last day of the 6th month
  • Expired vaccine should NEVER be administered. To prevent this, use CDC’s COVID-19 Vaccine Expiration Date Tracking Tool
  • As the expiration date approaches, contact the manufacturer to determine if it has been extended. Do not discard vaccine without ensuring the expiration date has passed.

Freezer

DO NOT store in a freezer. 

Refrigerator 

2°C and 8°C | 36°F and 46°F
  • Before mixing, the vaccine can be stored in the refrigerator for up to 10 weeks.
  • Monitor how long the vaccine has been in the refrigerator using CDC’s beyond-use date labels for Pfizer-BioNTech COVID-19 Vaccine.
  • Store the vaccine in the tray or box.
  • Protect from light.
  • Do NOT refreeze thawed vaccine.

Vial Storage During Use

Thawing Frozen Vials

up to 25ºC | 77ºF
  • If not previously thawed at 2ºC to 8ºC (35ºF to 46ºF), allow vials to thaw at room temperature [up to 25ºC (77ºF)] for 30 minutes.
  • Pfizer-BioNTech COVID-19 Vaccine multiple-dose vials with orange caps and labels with orange borders may be stored at 8°C to 25°C (46°F to 77°F) for a total
    of 12 hours prior to dilution.
  • After dilution, the vial should be held between 2ºC to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution. 
  • Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information from the Fact Sheet supersedes the number of hours printed on vial labels and cartons.

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: cvgovernment@pfizer.com