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Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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Indication & Authorized Use


Indication

COMIRNATY® (COVID-19 Vaccine, mRNA) 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 12 years of age and older.

Interchangeability

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY® (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older can be used interchangeably without presenting any safety or effectiveness concerns.

Because of the potential for vaccine administration errors, including dosing errors, COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

For vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.

Authorized Use

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

  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved 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
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from FDA to prevent COVID-19 to provide:

  • a 3-dose 3 mcg modRNA primary series to individuals 6 months through 4 years of age
  • a 2-dose 10 mcg modRNA primary series to individuals 5 through 11 years of age
  • a 2-dose 30 mcg modRNA primary series to individuals 12 years of age and older
  • a third 10 mcg modRNA primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise
  • a third 30 mcg modRNA primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise
  • a single 10 mcg modRNA booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine
  • a first 30 mcg modRNA booster dose to individuals 12 years of age and older who have completed a primary series with
    Pfizer-BioNTech COVID-19 Vaccine or
    COMIRNATY® (COVID-19 Vaccine, mRNA)
  • a first 30 mcg modRNA booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved 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
  • a second 30 mcg modRNA booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine
  • a second 30 mcg modRNA booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine

Important Safety Information

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

Management of Acute Allergic Reactions

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).

Myocarditis and Pericarditis

Myocarditis and pericarditis have been reported following administration of the vaccine.

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

Syncope

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.

Altered Immunocompetence

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

Limitation of Effectiveness

The vaccine may not protect all vaccine recipients.

Primary Series Adverse Events:

In a clinical study (3 mcg modRNA) of participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) of participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).

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%).

In clinical studies (30 mcg modRNA) of adolescents 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) were 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%), and injection site redness (8.6%).

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%).

Booster Dose Adverse Events:

In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

In a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first 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%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, have been reported following administration of the vaccine.

Myocarditis and pericarditis have been reported following administration of the vaccine.

Before administration of the vaccine, please click to see

Fact Sheets for individuals 6 months through 4 years of age
EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap
Recipients and Caregivers Fact Sheet (6 months through 4 years of age)
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)
Fact Sheets and Prescribing Information for individuals 12 years of age and older
Full Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap
Full Prescribing Information (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
EUA Fact Sheet for Vaccination Providers (12 years of age and older), DILUTE BEFORE USE, Purple Cap
Recipients and Caregivers Fact Sheet (12 years of age and older)


For More Information

Medical Information Medical Information

Medical Information

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

General Product Inquiries General Product Inquiries

General Product Inquiries

Call 1-877-829-2619

Shipment Support US Trade Customer Service Shipment Support US Trade Customer Service

Shipment Support
US Trade Customer Service

Call 1-800-666-7248

Pfizer Customer Service Pfizer Customer Service

Pfizer Customer Service

Call 1-800-879-3477

Labeling Update: Effective 07/08/22
NOW FDA APPROVED FOR USE IN INDIVIDUALS 12 THROUGH 15 YEARS OF AGE, IN ADDITION TO THE ALREADY APPROVED INDICATION FOR INDIVIDUALS 16 YEARS OF AGE AND OLDER

New Information In Teal

The Full Prescribing Information has been updated. Changes include (but are not limited to) the following sections:


1 INDICATIONS AND USAGE

COMIRNATY® (COVID-19 Vaccine, mRNA) 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 12 years of age and older.


6 ADVERSE REACTIONS

In a clinical study, the most commonly reported (≥8%) adverse reactions in adolescents 12 through 15 years of age following any dose were 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%), and injection site redness (8.6%).

Click below to view:


Selected Safety Information

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%).


Labeling Update: Effective 06/17/22
NOW AUTHORIZED FOR EMERGENCY USE FOR INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE

Click to view the recently issued EUA Fact Sheet for Vaccination Providers (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap.

Emergency Use Authorization

Emergency uses of the vaccine have not been approved or licensed by FDA, but have been authorized by FDA, under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals 6 months of age and older. The emergency uses are 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.

Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 6 months of age and older.

The 6 month through 4 years of age, Dilute Before Use, Maroon Cap, EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine supplied in a multiple dose vial with a maroon cap and a label with a maroon border, which is authorized for use in individuals 6 months through 4 years of age.

The vial labels may state “Age 2y to < 5y” or “Age 6m to < 5y” and carton labels may state “For age 2 years to < 5 years” or “For age 6 months to < 5 years.” Vials with either printed age range can be used for individuals 6 months through 4 years of age.

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of 3 doses (0.2 mL each). The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose in individuals 6 months through 4 years of age.

Individuals who will turn from 4 years to 5 years of age between any doses in the primary series may receive:

  • a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 through 11 years of age (each 0.2 mL dose containing 10 mcg modRNA, supplied in multiple dose vials with orange caps and labels with orange borders)

    • OR

  • a 3-dose primary series initiated with the Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (each 0.2 mL dose containing 3 mcg modRNA, supplied in multiple dose vials with maroon caps). Each of Doses 2 and 3 may be with:
    • Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 6 months through 4 years of age (supplied in multiple dose vials with maroon caps), or
    • Pfizer-BioNTech COVID-19 Vaccine authorized for use in individuals 5 years through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders)

Selected Safety Information

In a clinical study (3 mcg modRNA) of participants 6 through 23 months of age, adverse reactions following administration of any dose included irritability (68.4%), decreased appetite (38.6%), tenderness at the injection site (26.4%), injection site redness (17.8%), fever (14.4%), injection site swelling (7.3%), and lymphadenopathy (0.2%).

In a clinical study (3 mcg modRNA) of participants 2 through 4 years of age, adverse reactions following administration of any dose included pain at the injection site (47.0%), fatigue (44.8%), injection site redness (18.9%), fever (10.5%), headache (8.7%), injection site swelling (8.4%), chills (5.7%), muscle pain (5.0%), joint pain (2.4%), and lymphadenopathy (0.1%).


Labeling Update: Effective 05/17/22
INDIVIDUALS 5 THROUGH 11 YEARS OF AGE ARE AUTHORIZED TO RECEIVE A SINGLE BOOSTER DOSE

The Emergency Use Authorization (EUA) Fact Sheet for Vaccination Providers for individuals 5 through 11 years of age has been updated. Changes include (but are not limited to) the following sections:


2.3 Vaccination Schedule

Booster Dose
A single Pfizer-BioNTech COVID-19 Vaccine booster dose (0.2 mL) may be administered at least 5 months after completing a primary series of the Pfizer-BioNTech COVID-19 Vaccine to individuals 5 through 11 years of age.

Click to view the EUA Fact Sheet for Vaccination Providers (5 Through 11 Years), DILUTE BEFORE USE, Orange Cap.

Selected Safety Information

Booster Dose Adverse Events:
In a clinical study (10 mcg modRNA) in children 5 through 11 years of age, adverse reactions following administration of a single booster dose were injection site pain (73.9%), fatigue (45.6%), headache (34.0%), muscle pain (18.3%), injection site swelling (16.4%), injection site redness (15.6%), chills (10.5%), fever (6.7%), joint pain (6.7%), diarrhea (4.9%), lymphadenopathy (2.5%), and vomiting (2.4%).

EXPIRY INFORMATION

EXPIRY INFORMATION

AVAILABLE VACCINE PRESENTATIONS

As of 6/17/2022, the 6 months through 4 years of age, DILUTE BEFORE USE (Maroon Cap) presentation is available.

As of 4/13/2022, the shelf life for Ages 12 years and older, DO NOT DILUTE (Gray Cap) and 5 through 11 years of age, DILUTE BEFORE USE (Orange Cap) has been extended from 9 months to 12 months.

As of 4/26/2022, the shelf life for Ages 12 years and older, DILUTE BEFORE USE (Purple Cap) has been extended from 9 months to 12 months.

Because of the potential for vaccine administration errors, including dosing errors, COMIRNATY® (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine presentations should only be used for the ages specified on the vial labels, cartons, or the respective age-based Fact Sheet. The information in the Fact Sheets supersedes the information printed on the vial labels and cartons.

For vaccination of individuals advancing into the next age group (4 years of age turning 5 years of age or 11 years of age turning 12 years of age) between any primary series dose, refer to the respective age-based Fact Sheet for Healthcare Providers for instructions for administration.

Individuals 12 years of age and older should only be vaccinated with the 12 years of age and older DILUTE BEFORE USE, Purple Cap or DO NOT DILUTE, Gray Cap presentation. No other vaccine presentations should be used for individuals 12 years of age and older because of the potential for vaccine administration errors, including dosing errors. For individuals 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.

The vial labels may state “Age 2y to < 5y” or “Age 6m to < 5y” and carton labels may state “For age 2 years to < 5 years” or “For age 6 months to < 5 years.” Vials with either printed age range can be used for individuals 6 months through 4 years of age.

Description Dilute Before Use Do Not Dilute Dilute Before Use Dilute Before Use
Age Group 12 years and older 12 years and older 5 through 11 years
("Age 5y to <12y" on vial label) 		6 months through 4 years
(See information in maroon above the table.)
Vial Cap Color Purple
 Gray
 Orange
 Maroon
Dose 30 mcg 30 mcg 10 mcg 3 mcg
Dose Volume 0.3 mL 0.3 mL 0.2 mL 0.2 mL
Amount of Diluent Needed per Vial* 1.8 mL NO DILUTION 1.3 mL 2.2 mL
Doses per Vial 6 doses per vial
(after dilution)		 6 doses per vial 10 doses per vial
(after dilution)		 10 doses per vial
(after dilution)
Emergency Use Authorization (EUA) Fact Sheet Click here Click here Click here Click here
Storage Conditions
Ultra-Low-Temperature (ULT) Freezer
[-90°C to -60°C (-130°F to -76°F)] 		12 months† 12 months‡ 12 months‡ 12 months‡
Freezer
[-25°C to -15°C (-13°F to 5°F)] 		2 weeks DO NOT STORE DO NOT STORE DO NOT STORE
Refrigerator
[2°C to 8°C (35°F to 46°F)] 		1 month 10 weeks 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)		 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 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)] 		12 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)] 		12 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)] 		12 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
Description Dilute Before Use
Age Group 6 months through 4 years
(See information in maroon above the table.)
Vial Cap Color Maroon
Dose 3 mcg
Dose Volume 0.2 mL
Amount of Diluent Needed per Vial* 2.2 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)] 		12 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. Bacteriostatic saline or other diluents must NOT be used.

† Regardless of storage condition, purple cap vaccine should not be used past the 12-month expiry. For vials with expiry dates of October 2021 through March 2022, the printed date on the label/carton reflects 6-month expiry. For vials with expiry dates of June 2022 through December 2022, the printed date on the label/carton reflects 9-month expiry. The vaccine should not be used past the 12-month (updated) expiry date as noted in the Fact Sheet.

‡ Regardless of storage condition, gray, orange, and maroon cap vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons.

§ Vials should be discarded 12 hours after dilution, even though some vial and carton labels may state that a vial should be discarded 6 hours after dilution. The information in the Fact Sheet supersedes the information printed on vial labels and cartons.



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