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.
- FDA Emergency Use Authorization Letter
- EUA Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)
- EUA Fact Sheet for Vaccine 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.
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 cvdvaccine-us.com/.
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
Schedule: 0, 21 days
Dose preparation: Multi-dose; 5-6 doses per vial | Reconstitute with diluent (1.8 mL sterile 0.9% Sodium Chloride Injection, USP prior to use)
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
-25°C to -15°C | -13°F to 5°F
- Remove vial trays immediately from the shipper, then transfer to a freezer.
- Unopened vials: Up to 2 weeks. Vials must be kept frozen and protected from light until ready to use.
- The total cumulative time the vials are stored at freezer temperatures should be tracked and should not exceed 2 weeks.
- Vials stored at -25° to -15°C (-13° to 5°F) for up to two weeks may be returned one time to the recommended storage condition of -80° to -60°C (-112° to -76°F).
Pfizer Thermal Shipper with Dry Ice
-80°C to -60°C | -112°F to -76°F
- Quickly inspect the vaccine vial trays, then close the shipper. A new shipment of dry ice will arrive within 24 hours. Replace the dry ice in the shipper as soon as you receive the shipment. Replace every 5 days to maintain the desired temperature. You will only receive the initial shipment of dry ice; You must supply the remainder of dry ice needed.
- Unopened vials: Up to 30 days – Louisiana guidelines state the goal should be to administer any allocated vaccine within 14 days of receipt.
- The thermal shipper should only be opened twice daily at a maximum of 3 minutes each.
2°C to 8°C | 36°F to 46°F
- Unopened vials: 30 days
- Punctured vials: up to 6 hours after dilution | 2°C to 25°C (35°F to 77°F)
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: Up to 2 hours, undiluted
- Punctured vial: Up to 6 hours after dilution | 2°C to 25°C (35°F to 77°F)
- Must be reconstituted within the first 2 hours. After dilution, use within 6 hours from the time of dilution.
Thawed vaccine CANNOT be refrozen.
Temperature Excursions for Pfizer-BioNTechIn the event of a temperature excursion, contact Pfizer-BioNTech: