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Pfizer-BioNTech
COVID-19 Vaccine

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

Booster Dose

12 Years of
Age and Older

AUTHORIZED FOR EMERGENCY USE1-6

Emergency uses of the vaccines 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 for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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 (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 for primary series doses without presenting any safety or effectiveness concerns.

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.

maroon-logo

IMPORTANT MAROON CAP VIAL INFORMATION:
6 MONTHS THROUGH 4 YEARS OF AGE, DILUTE BEFORE USE, MAROON CAP

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.

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
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)]
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

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)]
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

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)]
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

Pfizer-BioNTech COVID-19 Vaccine
6 MONTHS THROUGH
4 YEARS OF AGE,
DILUTE BEFORE USE

Maroon Caps

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)]
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§

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)]
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

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)]
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

*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 12 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 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. §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.

References
  1. Pfizer-BioNTech COVID-19 Vaccine. 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; August 31, 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; October 12, 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; October 12, 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; October 12, 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 August 31, 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; October 18, 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 & Authorized Uses

Indication & Authorized Use

Important Safety Information

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Important Safety Information

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Indication & Authorized Uses


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

Authorized Use

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.

Interchangeability (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.

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.

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

Authorized Use

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



Important Safety Information

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

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

Postmarketing safety data with Pfizer-BioNTech COVID-19 Vaccine are relevant to Pfizer-BioNTech COVID-19 Vaccine, Bivalent because these vaccines are manufactured using the same process.

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 the 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

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 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 clinical studies (30 mcg modRNA) of participants 12 through 15 years of age, the most commonly reported adverse reactions (≥8%) 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%).

In clinical studies (30 mcg modRNA) of participants 16 through 55 years of age, the most commonly reported adverse reactions (≥10%) following any dose 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%) following any dose 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

The safety of a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent 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 and booster vaccination with Pfizer-BioNTech COVID-19 Vaccine, and
  • post marketing safety data with Pfizer-BioNTech COVID-19 Vaccine

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.

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%).

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%).

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%).

Post Authorization Experience

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

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

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 the Pfizer-BioNTech COVID-19 Vaccine, Bivalent.

Before administration of primary series dose vaccination, please click to see




Before administration of booster dose vaccination, please click to see



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