Adult Dose Pfizer-BioNTech & COMIRNATY COVID-19 Vaccine

The Pfizer-BioNTech COVID-19 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 and to provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

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.

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 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.

COMIRNATY COVID-19 VaccineCOMIRNATY (Koe-mir'-na-tee) (COVID-19 vaccine, mRNA) is an FDA-approved COVID-19 vaccine made by Pfizer-BioNTech. It is approved as a 2-dose series for the prevention of COVID-19 in individuals 16 years of age and older and is also authorized for emergency use in individuals 12 through 15 years and to provide a third dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise.

The FDA-approved COMIRNATY and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

For more information on the Pfizer-BioNTech COVID-19 Vaccine, visit

Adult Dose Pfizer-BioNTech COVID-19 Vaccine Overview

Pfizer-BioNTech COVID-19 Vaccine is supplied in a multiple-dose vial with a purple cap and a label with a purple 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: 0, 21 days

Dose preparation: Multi-dose; 5-6 doses per vial | DO NOT MIX with 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




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 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

Temperature Excursions for Pfizer-BioNTechIn the event of a temperature excursion, contact Pfizer-BioNTech: 

Phone:  (800) 666-7248