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.
- 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.
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
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.
DO NOT store in a freezer.
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.
Temperature Excursions for Pfizer-BioNTechIn the event of a temperature excursion, contact Pfizer-BioNTech: