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COVID-19 Vaccines

  • Pfizer-BioNTech COVID-19
    Vaccine

  • Pfizer-BioNTech
    COVID-19 Vaccine, Bivalent
    (Original and Omicron BA.4/BA.5)
12 Years of Age and Older
Primary Series
(Pfizer-BioNTech COVID-19 Vaccine)
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Bivalent Booster
(Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5))
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5 Through 11 Years of Age
Primary Series
(Pfizer-BioNTech COVID-19 Vaccine)
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Bivalent Booster
(Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5))
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6 Months Through 4 Years of Age
Primary Series
(Pfizer-BioNTech COVID-19 Vaccine & Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original & Omicron, BA.4/BA.5)) Pfizer-BioNTech COVID-19 Vaccine & Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron, BA.4/BA.5)
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AUTHORIZED FOR EMERGENCY USE1-6

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 aged 6 months and older as appropriate. 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

COMIRNATY® (COVID-19 Vaccine, mRNA) IS FDA APPROVED FOR 12 YEARS OF AGE AND OLDER7,8

In individuals 12 years of age and older, COMIRNATY® (COVID-19 Vaccine, mRNA) has been approved as a two-dose primary series for active immunization to prevent COVID-19 caused by SARS-CoV-2. Please refer to Emergency Use Authorization Fact Sheets for Authorized Uses.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY 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.

Age-Specific Vaccine Presentation Information

Because of the potential for vaccine administration errors, including dosing errors, 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.

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IMPORTANT MAROON CAP VIAL INFORMATION FOR
PFIZER-BIONTECH COVID-19 VACCINE:
6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE, MAROON CAP

The original monovalent Pfizer-BioNTech COVID-19 Vaccine 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.

Pfizer-BioNTech COVID-19 Vaccine is no longer supplied in vials with a purple cap in the US. For information related to Pfizer-BioNTech COVID-19 Vaccine, Dilute Before Use, purple cap, please review, the EUA Fact Sheet, the full Prescribing Information or visit cvdvaccine-us.com. Expiry information can be found at: https://lotexpiry.cvdvaccine.com/

Formulation/Presentation Guide

Refer to the information outlined below to understand the formulations and presentations of the vaccines.

Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5)
12 YEARS OF AGE AND OLDER,
DO NOT DILUTE, BIVALENT

Gray Caps

Gray Cap4

DOSE
30 mcg

DOSE VOLUME
0.3 mL

AMOUNT OF DILUENT NEEDED PER VIAL
NO DILUTION

DOSES PER VIAL
Single dose vial: 1 dose per vial
Multiple dose vial: 6 doses per vial

REFRIGERATED STORAGE TIME
10 weeks

Storage Conditions

ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
18 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

Pfizer-BioNTech COVID-19 Vaccine 12 YEARS OF AGE AND OLDER,
DO NOT DILUTE

Gray Caps

Gray Cap5

DOSE
30 mcg

DOSE VOLUME
0.3 mL

AMOUNT OF DILUENT NEEDED PER VIAL
NO DILUTION

DOSES PER VIAL
6 doses per vial

REFRIGERATED STORAGE TIME
10 weeks

Storage Conditions

ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
18 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

Pfizer-BioNTech COVID-19 Vaccine 12 YEARS OF AGE
AND OLDER, DILUTE BEFORE USE

Purple Caps

Purple Cap6

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)

REFRIGERATED STORAGE TIME
1 month

Storage Conditions

ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
18 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

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) 5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE, BIVALENT


Orange Caps

Orange Cap2

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)

REFRIGERATED STORAGE TIME
10 weeks

Storage Conditions

ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
18 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

Pfizer-BioNTech COVID-19 Vaccine 5 THROUGH 11 YEARS OF AGE,
DILUTE BEFORE USE


Orange Caps

Orange Cap3

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)

REFRIGERATED STORAGE TIME
10 weeks

Storage Conditions

ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
18 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

Pfizer-BioNTech COVID-19 Vaccine
AND
Pfizer-BioNTech COVID-19 Vaccine,
Bivalent (Original and Omicron BA.4/BA.5) 6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE
Primary Series

Maroon Caps Maroon Caps Ingredient

Maroon Cap1

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)

REFRIGERATED STORAGE TIME
10 weeks

Storage Conditions

ULTRA-LOW-TEMPERATURE (ULT) FREEZER [-90°C to -60°C (-130°F to -76°F)]
18 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§

*ONLY use sterile 0.9% Sodium Chloride Injection, USP as the diluent. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent. †Regardless of storage condition, maroon, orange, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vial and cartons. ‡Regardless of storage condition, purple cap vaccine should not be used past the 18-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 18-month (updated) expiry date as noted in the Fact Sheet. §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.
FORMULATION/PRESENTATION GUIDE

References
  1. Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5). Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap. Pfizer and BioNTech; December 8, 2022.
  2. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5), (Booster Dose for 5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; December 8, 2022
  3. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (5 through 11 years of age), DILUTE BEFORE USE, Orange Cap. Pfizer and BioNTech; December 8, 2022
  4. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers), Bivalent (Original and Omicron BA.4/BA.5) (Booster Dose for 12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; December 8, 2022
  5. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech December 8, 2022
  6. Pfizer-BioNTech COVID-19 Vaccine. Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; November 22, 2022.
  7. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DILUTE BEFORE USE, Purple Cap. Pfizer and BioNTech; July 8, 2022.
  8. COMIRNATY® (COVID-19 Vaccine, mRNA). Prescribing Information (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; July 8, 2022.

INDICATION AND AUTHORIZED USE

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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INDICATION AND AUTHORIZED USE


COMIRNATY® (COVID-19 Vaccine, mRNA)


Indication & Authorized Use

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. It is also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Authorized Use

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent are 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.

Interchangeability of COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine (Primary Series for Individuals 12 Years of Age and Older)

When prepared according to their respective instructions for use, the FDA-approved COMIRNATY 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.

Age-Specific Vaccine Presentation Information

Because of the potential for vaccine administration errors, including dosing errors, 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.


Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY (COVID-19 Vaccine, mRNA), or Pfizer-BioNTech COVID-19 Vaccine, Bivalent to individuals with known history of a severe allergic reaction (eg, anaphylaxis) to any component of the vaccines.

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 Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

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

Postmarketing data with authorized or approved monovalent mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following receipt of the second primary series dose or first booster dose, with most booster doses likely administered at least 5 months after completing primary vaccination. For Pfizer-BioNTech COVID-19 Vaccine, the observed risk is higher among adolescent males and adult males under 40 years of age than among females and older males, and 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 Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Limitation of Effectiveness

Pfizer-BioNTech COVID-19 Vaccine, COMIRNATY, or Pfizer-BioNTech COVID-19 Vaccine, Bivalent may not protect all vaccine recipients.

Adverse Reactions

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (individuals 5 years of age and older) and for the third dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated a booster dose of Pfizer-BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1),
  • safety data from clinical trials which evaluated primary (6 months of age and older) and booster (5 years of age and older) vaccination with Pfizer-BioNTech COVID-19 Vaccine, and
  • postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent

The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

In a clinical study (3 mcg modRNA) of participants 6 through 23 months of age, adverse reactions following administration of any dose of Pfizer-BioNTech COVID-19 Vaccine 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 of Pfizer-BioNTech COVID-19 Vaccine 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) of participants 5 through 11 years of age, adverse reactions following administration of any primary series dose of Pfizer-BioNTech COVID-19 Vaccine 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 a clinical study (10 mcg modRNA) of participants 5 through 11 years of age, adverse reactions following administration of a single booster dose of Pfizer-BioNTech COVID-19 Vaccine 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 clinical studies (30 mcg modRNA) of participants 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) following any dose of Pfizer-BioNTech COVID-19 Vaccine 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%) following any dose of Pfizer-BioNTech COVID-19 Vaccine 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 a clinical study (30 mcg modRNA) of participants 18 through 55 years of age, adverse reactions following administration of a first booster dose of Pfizer-BioNTech COVID-19 Vaccine 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%). Severe allergic reactions (including anaphylaxis), myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine.

In clinical studies (30 mcg modRNA) of participants 56 years of age and older, the most commonly reported adverse reactions (≥10%) following any dose of Pfizer-BioNTech COVID-19 Vaccine 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%).

The clinical study (30 mcg modRNA) that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

Post Authorization Experience

Severe allergic reactions, including anaphylaxis, and other hypersensitivity reactions (eg, rash, pruritus, urticaria, angioedema), diarrhea, vomiting, pain in extremity (arm), syncope, and dizziness have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Myocarditis and pericarditis have been reported following administration of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Additional adverse reactions, some of which may be serious, may become apparent with more widespread use of Pfizer-BioNTech COVID-19 Vaccine and post authorization use of Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Before administration, please click to see:


EUA Fact Sheet for Vaccination Providers

6 months through 4 years of age - Monovalent and Bivalent Primary Series - Maroon Cap
5 through 11 years of age - Monovalent Primary Series - Orange Cap
5 through 11 years of age - Bivalent Booster - Orange Cap
12 years of age and older - Monovalent Primary Series - Gray Cap
12 years of age and older - Monovalent Primary Series - Purple Cap
12 years of age and older - Bivalent Booster - Gray Cap

Full Prescribing Information

COMIRNATY Full Prescribing Information - 12 years of age and older - Gray Cap
COMIRNATY Full Prescribing Information - 12 years of age and older - Purple Cap

EUA Fact Sheet for Recipients and Caregivers

6 months through 4 years of age
5 through 11 years of age
12 years of age and older



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Now Authorized: Effective 12/08/22

Pfizer-BioNTech COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) IS NOW AUTHORIZED FOR EMERGENCY USE AS DOSE 3 IN A THREE-DOSE PRIMARY SERIES IN ELIGIBLE INDIVIDUALS 6 MONTHS THROUGH 4 YEARS OF AGE

Click to view the EUA Fact Sheet for Vaccination Providers, Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) (6 months through 4 years of age), DILUTE BEFORE USE, Maroon Cap

Emergency Use Authorization

Emergency uses of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 aged 6 months and older as appropriate. 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. Please see EUA Fact Sheets at www.cvdvaccine-us.com.

Changes include but are not limited to the following sections:

New Language in Teal

1 Authorized Use

Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) are 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.

This EUA Prescribing Information pertains only to Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), hereafter referred to as Pfizer-BioNTech COVID-19 Vaccine, Bivalent, supplied in multiple dose vials with maroon caps and labels with maroon borders, which are authorized for use in individuals 6 months through 4 years of age.

2.3 Vaccination Schedule

The Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 6 months through 4 years of age are supplied in multiple dose vials with maroon caps and labels with maroon borders and after dilution are administered intramuscularly as a 3-dose (0.2 mL each) primary series as follows:
Dose 1: Pfizer-BioNTech COVID-19 Vaccine
Dose 2: Pfizer-BioNTech COVID-19 Vaccine
Dose 3: Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Dose 1 and Dose 2 (Pfizer-BioNTech COVID-19 Vaccine) are administered 3 weeks apart. Dose 3 (Pfizer-BioNTech COVID-19 Vaccine, Bivalent) is administered at least 8 weeks after the Dose 2.

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

  • a 3-dose primary series comprised of Pfizer-BioNTech COVID-19 Vaccine (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Doses 1 and 2 and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (supplied in multiple dose vials with maroon caps and labels with maroon borders) for Dose 3, or
  • a 2-dose primary series with the Pfizer-BioNTech COVID-19 Vaccine authorized for use for individuals 5 through 11 years of age (supplied in multiple dose vials with orange caps and labels with orange borders).

6 OVERALL SAFETY SUMMARY

. . .

The safety of Pfizer-BioNTech COVID-19 Vaccine for the first and second dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months through 4 years of age,
  • safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 5 years of age and older, and
  • postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine.

The safety of the Pfizer-BioNTech COVID-19 Vaccine, Bivalent for the third dose of the primary series in individuals 6 months through 4 years of age is based on:

  • safety data from a clinical study which evaluated a booster dose with Pfizer BioNTech’s bivalent COVID-19 vaccine (Original and Omicron BA.1), not authorized or approved, hereafter referred to as bivalent vaccine (Original and Omicron BA.1) in individuals greater than 55 years of age,
    • The safety data accrued with the bivalent vaccine (Original and Omicron BA.1) and with the Pfizer-BioNTech COVID-19 Vaccine are relevant to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.
  • safety data from clinical studies which evaluated primary vaccination with Pfizer-BioNTech COVID-19 Vaccine in individuals 6 months of age and older and
  • safety data from clinical studies which evaluated booster vaccination with Pfizer-BioNTech COVID-19 Vaccine (previously, but no longer, authorized) in individuals 5 years of age and older, and
  • postmarketing safety data with the Pfizer-BioNTech COVID-19 Vaccine and the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

In a clinical study (Study 3) in participants 6 through 23 months of age who received Pfizer-BioNTech COVID-19 Vaccine containing 3 mcg of a nucleoside-modified messenger RNA encoding the spike (S) glycoprotein of SARS-CoV-2 (3 mcg nucleoside modified messenger RNA (modRNA)), 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 (Study 3) in participants 2 through 4 years of age who received Pfizer-BioNTech COVID-19 Vaccine (3 mcg modRNA), 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%).

The clinical study that evaluated a booster dose of the bivalent vaccine (Original and Omicron BA.1) included participants greater than 55 years of age. The bivalent vaccine (Original and Omicron BA.1) contained 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and 15 mcg of modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.1, for a total of 30 mcg modRNA per dose. Adverse reactions following administration of the bivalent vaccine (Original and Omicron BA.1) as a second booster dose included pain at the injection site (58.1%), fatigue (49.2%), headache (33.6%), muscle pain (22.3%), chills (13.0%), joint pain (11.3%), injection site redness (7.0%), injection site swelling (6.6%), fever (5.0%), lymphadenopathy (0.3%), nausea (0.3%), and malaise (0.3%).

Expiry Update: Effective 12/08/22

Expiry dates included in product labeling for maroon cap, orange cap, and gray cap presentations of Pfizer-BioNTech COVID-19 Vaccine and Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) have been updated from 12 to 18 months after the date of manufacture printed on the vials and cartons.

Verify the vials (including labels) prior to preparation and administration to help avoid dosing errors. Check gray cap, orange cap, and maroon cap vial labels to ensure that the name on the vial states “Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).” Please see the Formulation/Presentation Guide for more details.

Formulation/
Presentation Guide
Expiry Information

Regardless of storage condition, the maroon cap, orange cap, and gray cap vaccines should not be used after 18 months from the date of manufacture printed on the vials and cartons.

I acknowledge that this website is being updated on an ongoing basis. I have read the Important Safety Information below. I will check back for further updates.

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