Full Prescribing Information & EUA Fact Sheets

FDA EUA Letter Full Prescribing Information (FDA Approved - 16 Years & Up) EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DILUTE BEFORE USE, Purple Cap EUA Fact Sheet for Vaccination Providers (12 Years & Up) – DO NOT DILUTE, Gray Cap EUA Fact Sheet for Vaccination Providers (5 to <12 Years Old) – DILUTE BEFORE USE, Orange Cap EUA Fact Sheet for Recipients and Caregivers - 12 Years & Up EUA Fact Sheet for Recipients and Caregivers (5 to <12 Years Old)

Three vaccine presentations are now available with different preparation and storage guidelines.
See immediately below for information on Gray Cap and Orange Cap vials.

For dosing, preparation, and storage guidelines for Ages 12 years and older DO NOT DILUTE Gray Cap presentation:

View the EUA Fact Sheet for Vaccination Providers

Click here for expiry information.

For dosing, preparation, and storage guidelines for Ages 5 through 11 years DILUTE BEFORE USE Orange Cap presentation:

View the EUA Fact Sheet for Vaccination Providers

Click here for expiry information.

Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation.

Dosing and Administration1

Vaccination Schedule

PRIMARY SERIES2

The vaccine is administered as a primary series of 2 doses three weeks apart in individuals 12 years of age and older
Day 0

30 mcg (0.3 mL)

Intramuscular Injection
Day 21

30 mcg (0.3 mL)

Intramuscular Injection

For Immunocompromised Individuals with Certain Conditions:

A third primary series dose of the vaccine 30 mcg (0.3 mL) administered at least 28 days following the second dose is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

BOOSTER DOSE2 - To Be Updated

The vaccine is administered as a single booster dose at least 6 months after completing the primary series to individuals:
65 years of age and older

30 mcg (0.3 mL)

Intramuscular Injection
18 through 64 years of age at high risk of severe COVID-19

30 mcg (0.3 mL)

Intramuscular Injection
18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2

30 mcg (0.3 mL)

Intramuscular Injection

For those who have completed primary vaccination with a different authorized COVID-19 vaccine:

A single booster dose may be administered to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the two EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for ages 12 years and older can be used interchangeably without presenting any safety or effectiveness concerns, but  should not be used for individuals 5 through 11 years of age, because of the potential for vaccine administration errors, including dosing errors.

Multiple Dose Vial – Six Doses

After dilution, vials of the vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Do not pool excess vaccine from multiple vials

Description

The vaccine is a sterile suspension for injection for intramuscular use. It is supplied as a frozen suspension in multiple dose vials; each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine. Each dose of the vaccine contains 30 mcg of a nucleoside-modified messenger RNA (mRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2.

Each 0.3 mL dose of the vaccine also includes the following ingredients: lipids (0.43 mg ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate), 0.05 mg 2-(polyethylene glycol 2000)-N, N-ditetradecylacetamide, 0.09 mg 1, 2-distearoyl-sn-glycero-3-phosphocholine, and 0.2 mg cholesterol), 0.01 mg potassium chloride, 0.01 mg monobasic potassium phosphate, 0.36 mg sodium chloride, 0.07 mg dibasic sodium phosphate dihydrate, and 6 mg sucrose. The diluent (0.9% Sodium Chloride Injection, USP) contributes an additional 2.16 mg sodium chloride per dose.

The vaccine does not contain preservative.

The vial stoppers are not made with natural rubber latex.

Dose Preparation

  • The Multiple Dose Vial contains a volume of 0.45 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration
  • Vials may be thawed in the refrigerator [2°C to 8°C (35°F to 46°F)] or at room temperature [up to 25°C (77°F)]
  • Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles
  • The contents of the vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form the vaccine
  • After dilution, the vial contains 6 doses of 0.3 mL of vaccine
  • 0.9% Sodium Chloride Injection, USP is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. Do not add more than 1.8 mL of diluent. Please see the Q&A section for more information on dose preparation
  • After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discoloration is observed
  • Strict adherence to aseptic techniques must be followed

Thawing Prior to Dilution
Thaw
  • Thaw vial(s) of the vaccine before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month
    • Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes
  • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours
First Mix

Invert

  • Before dilution invert vaccine vial gently 10 times
  • Do not shake
  • Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles
  • Do not use if liquid is discolored or if other particles are observed
Inject Saline

Dilute

  • ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent
  • Using aseptic technique, withdraw 1.8 mL of diluent into a transfer syringe (21-gauge or narrower needle)
  • Cleanse the vaccine vial stopper with a single-use antiseptic swab
  • Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial
Remove Air

Equalize

  • Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL of air into the empty diluent syringe
Second Mix

Invert

  • Gently invert the vial containing the vaccine 10 times to mix
  • Do not shake
  • Inspect the vaccine in the vial
  • The vaccine will be an off-white suspension. Do not use if vaccine is discolored or contains particulate matter
text B&W

Record and Store

  • Record the date and time of dilution on the vial label
  • Store between 2°C to 25°C (35°F to 77°F)
  • Discard any unused vaccine 6 hours after dilution

Preparation of Individual 0.3 mL Doses of the Vaccine

Draw Dose

Cleanse

  • Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the vaccine preferentially using low dead-volume syringes and/or needles
  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in a single vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Administer immediately

Administration

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off-white suspension. During the visual inspection,

  • verify the final dosing volume of 0.3 mL
  • confirm there are no particulates and that no discoloration is observed
  • do not administer if vaccine is discolored or contains particulate matter

Administer the vaccine intramuscularly.

After dilution, vials of the vaccine contain six doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract six doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:

  • Each dose must contain 0.3 mL of vaccine
  • If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume
  • Do not pool excess vaccine from multiple vials

Review the Product Safety Data Sheet for the vaccine. In the event of vial breakage, damage, or leakage, to prevent cuts and exposure to the vaccine, do not handle the vial with bare hands; wear protective gloves. Remove broken glass with forceps, tongs, or other appropriate tools. Dispose of the vial and vial pieces in a medical sharps container.

  • Important Safety Information

    Indication & Authorized Use

    Important Safety Information

    • Do not administer to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccine.

    • Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of the vaccine.

    • Monitor vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

    • Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose.

    • Syncope (fainting) may occur in association with administration of injectable vaccines, in particular in adolescents. Procedures should be in place to avoid injury from fainting.

    • Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.

    • The vaccine may not protect all vaccine recipients.

    • Primary Series Adverse Events:
      In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).

    • In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) were pain at the injection site (78.2%), fatigue (56.9%), headache (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).

    • In a clinical study (30 mcg modRNA) of adolescents 12 through 15 years of age, adverse reactions following the administration of the primary series included pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

    • In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of any primary series dose included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), nausea (0.4%), rash (0.3%), malaise (0.1%), and decreased appetite (0.1%).

    • Booster Dose Adverse Events:
      In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

    • Before administration of the vaccine, please click to see
      Fact Sheets and Prescribing Information for individuals 12 years of age and older
      Full Prescribing Information (16 years of age and older)
      EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
      EUA Fact Sheet for Vaccination Providers (12 years of age and older), DO NOT DILUTE, Gray Cap
      Recipients and Caregivers Fact Sheet (12 years of age & older)
      Fact Sheets for individuals 5 through 11 years of age
      EUA Fact Sheet for Vaccination Providers (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap
      Recipients and Caregivers Fact Sheet (5 through 11 years of age)

    Indication & Authorized Use

    The FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the 2 EUA-authorized formulations of Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older, when prepared according to their respective instructions for use, can be used interchangeably.


    COMIRNATY® (COVID-19 Vaccine, mRNA) and the 2 formulations of Pfizer-BioNTech COVID-19 Vaccine intended for individuals 12 years of age and older should not be used for individuals 5 through 11 years of age because of the potential for vaccine administration errors, including dosing errors.


    Indication

    COMIRNATY® is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

    Authorized Use

    The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 in individuals 5 years of age and older to provide:

    • a 10 mcg modRNA 2-dose primary series to individuals 5 through 11 years of age
    • a 30 mcg modRNA 2-dose primary series to individuals 12 years of age and older
    • a 30 mcg modRNA third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination

    COMIRNATY® (COVID-19 Vaccine, mRNA) is authorized for emergency use to provide:

    • a 30 mcg modRNA 2-dose primary series to individuals 12 through 15 years of age
    • a 30 mcg modRNA third primary series dose to individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY®
    • a 30 mcg modRNA single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorized for a booster dose of the vaccine used for primary vaccination

Ensuring the Authenticity of Pfizer-BioNTech COVID-19 Vaccine and Registered Trademark Name COMIRNATY®

If you suspect the vaccine you have purchased may be counterfeit, contact us at 1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.

To learn more, visit https://www.pfizer.com/counterfeiting/frequently-asked-questions.

References
  1. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information. Pfizer and BioNTech; August 23, 2021.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers). Pfizer and BioNTech; October 20, 2021.
  3. Data on File. Pfizer Inc. New York, NY.
  4. COVID-19 Vaccination Program Interim Playbook for Jurisdiction Operations – September 16, 2020 Version 1.0. Centers for Disease Control and Prevention; 2020.
  5. McCurry MC. Secure disposal of vaccine vials and packaging recommendations. US Department of Defense; 2020.

For more information

Pfizer Customer Service
Call 1-800-879-3477.

Medical Information
Visit PfizerMedicalInformation.com or call 1-800-438-1985.

General Product Inquiries
Call 1-877-829-2619.

Shipment Support
US Trade Customer Service
Call 1-800-666-7248.

Label Update: Effective 11/19/21

Changes include (but are not limited to) the following sections:
New Language in Teal

2.3 Vaccination Schedule
Booster Dose
A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.3 mL) may be administered intramuscularly at least 6 months after completing the primary series to individuals 18 years of age and older.

Click below to view:

Selected Safety Information
Booster Dose Adverse Events - In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), joint pain (25.3%), lymphadenopathy (5.2%), nausea (0.7%), decreased appetite (0.3%), rash (0.3%), and pain in extremity (0.3%).

Label Update: Effective 10/29/21

THREE VACCINE PRESENTATIONS ARE NOW AVAILABLE

Three vaccine presentations are now available with different preparation and storage guidelines.

Children ages 5 through 11 years old should only be vaccinated with the Ages 5 through 11 years (“Age 5y to <12y” on vial label) Dilute Before Use Orange Cap presentation. No other vaccine presentation should be used for children 5 through 11 years old because of the potential for vaccine administration errors, including dosing errors. For children who will turn 12 between their first and second dose, consult the EUA Fact Sheets for Vaccination Providers.

For questions, contact US Medical Information at 1-800-438-1985 or visit PfizerMedicalInformation.com.

Description Dilute Before Use Do Not Dilute Dilute Before Use
Age Group 12 years and older 12 years and older 5 through 11 years
("Age 5y to <12y" on vial label)
Vial Cap Color PURPLE
 GRAY
 ORANGE
Dose 30 mcg 30 mcg 10 mcg
Dose Volume 0.3 mL 0.3 mL 0.2 mL
Amount of Diluent Needed per Vial* 1.8 mL NO DILUTION 1.3 mL
Doses per Vial 6 doses per vial
(after dilution)		 6 doses per vial 10 doses per vial
(after dilution)
Emergency Use Authorization (EUA) Fact Sheet Click here Click here Click here
Storage Conditions
Ultra-Low-Temperature (ULT) Freezer
[-90°C to -60°C (-130°F to -76°F)]		 9 months† 6 months‡ 6 months‡
Freezer
[-25°C to -15°C (-13°F to 5°F)]		 2 weeks DO NOT STORE DO NOT STORE
Refrigerator
[2°C to 8°C (35°F to 46°F)]		 1 month 10 weeks 10 weeks
Room Temperature
[8°C to 25°C (46°F to 77°F)]		 2 hours prior to dilution
(including any thaw time)		 12 hours prior to first puncture
(including any thaw time)		 12 hours prior to dilution
(including any thaw time)
After First Puncture
[2°C to 25°C (35°F to 77°F)] 		Discard after 6 hours Discard after 12 hours Discard after 12 hours
Description Dilute Before Use
Age Group 12 years and older
Vial Cap Color PURPLE
Dose 30 mcg
Dose Volume 0.3 mL
Amount of Diluent Needed per Vial* 1.8 mL
Doses per Vial 6 doses per vial
(after dilution)
Emergency Use Authorization (EUA) Fact Sheet Click here
Storage Conditions
Ultra-Low-Temperature (ULT) Freezer
[-90°C to -60°C (-130°F to -76°F)]		 9 months†
Freezer
[-25°C to -15°C (-13°F to 5°F)]		 2 weeks
Refrigerator
[2°C to 8°C (35°F to 46°F)]		 1 month
Room Temperature
[8°C to 25°C (46°F to 77°F)]		 2 hours prior to dilution
(including any thaw time)
After First Puncture
[2°C to 25°C (35°F to 77°F)] 		Discard after 6 hours
Description Do Not Dilute
Age Group 12 years and older
Vial Cap Color GRAY
Dose 30 mcg
Dose Volume 0.3 mL
Amount of Diluent Needed per Vial* NO DILUTION
Doses per Vial 6 doses per vial
Emergency Use Authorization (EUA) Fact Sheet Click here
Storage Conditions
Ultra-Low-Temperature (ULT) Freezer
[-90°C to -60°C (-130°F to -76°F)]		 6 months‡
Freezer
[-25°C to -15°C (-13°F to 5°F)]		 DO NOT STORE
Refrigerator
[2°C to 8°C (35°F to 46°F)]		 10 weeks
Room Temperature
[8°C to 25°C (46°F to 77°F)]		 12 hours prior to first puncture
(including any thaw time)
After First Puncture
[2°C to 25°C (35°F to 77°F)] 		Discard after 12 hours
Description Dilute Before Use
Age Group 5 through 11 years
("Age 5y to <12y" on vial label)
Vial Cap Color ORANGE
Dose 10 mcg
Dose Volume 0.2 mL
Amount of Diluent Needed per Vial* 1.3 mL
Doses per Vial 10 doses per vial
(after dilution)
Emergency Use Authorization (EUA) Fact Sheet Click here
Storage Conditions
Ultra-Low-Temperature (ULT) Freezer
[-90°C to -60°C (-130°F to -76°F)]		 6 months‡
Freezer
[-25°C to -15°C (-13°F to 5°F)]		 DO NOT STORE
Refrigerator
[2°C to 8°C (35°F to 46°F)]		 10 weeks
Room Temperature
[8°C to 25°C (46°F to 77°F)]		 12 hours prior to dilution
(including any thaw time)
After First Puncture
[2°C to 25°C (35°F to 77°F)] 		Discard after 12 hours

*Diluent: sterile 0.9% Sodium Chloride Injection, USP. Bacterostatic saline or other diluents must NOT be used.
†Regardless of storage condition, vaccine should not be used past the 9 month expiry (6 months printed on the vial plus additional 3 months).
‡Regardless of storage condition, vaccines should not be used after 6 months from the date of manufacture printed on the vial and cartons.

I acknowledge that this website is being updated on an ongoing basis. Unless otherwise specified, the remainder of the website applies only to the Ages 12 & Up DILUTE BEFORE USE Purple Cap Presentation. I will check back for further updates.

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