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6 months through 4 years of age

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

FDA AUTHORIZED FOR EMERGENCY USE1

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.

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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 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.

There are differences in dosing and preparation instructions across select vaccine presentations.1-3
Please see the respective age-based Fact Sheets for dosing, preparation, and storage guidelines.

AGES 6 MONTHS THROUGH 4 YEARS, DILUTE BEFORE USE

6 MONTHS THROUGH
4 YEARS OF AGE DILUTE BEFORE USE
(MAROON CAP)

Storage & Handling Dosing & Preparation Resources
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) (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) (12 years of age and older), DO NOT DILUTE, Gray Cap. Pfizer and BioNTech; December 8, 2022.

Indication & Authorized Use

Indication & Authorized Use

Important Safety Information

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Important Safety Information

 


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:

  • 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 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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Information Updates

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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.

Now Authorized: Effective 03/14/23

Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is now authorized for use in individuals 6 months through 4 years of age to provide a single booster dose at least 2 months after completion of primary vaccination with 3 doses of the monovalent Pfizer-BioNTech COVID-19 Vaccine

NOTE: The original monovalent Pfizer-BioNTech COVID-19 Vaccine was previously but is no longer authorized for use as the third dose of the primary series in 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

Changes include but are not limited to the following sections:
New Language in Teal and Bold

2.3 Vaccination Schedule
. . .

Booster Dose

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is authorized for use in individuals 6 months through 4 years of age to provide a single booster dose (0.2 mL) at least 2 months after completion of primary vaccination with 3 doses of the Pfizer-BioNTech COVID-19 Vaccine.

NOTE: The original monovalent Pfizer-BioNTech COVID-19 Vaccine was previously but is no longer authorized for use as the third dose of the primary series in individuals 6 months through 4 years of age.


6 OVERALL SAFETY SUMMARY
. . .


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

  • safety data from clinical studies which evaluated a booster dose of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) in individuals 6 months of age and older,
  • 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

. . .

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

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is made up of equal parts of modRNA encoding the S-glycoprotein of SARS-CoV-2 Wuhan-Hu1 strain (Original) and modRNA encoding the S-glycoprotein of SARS-CoV-2 Omicron variant lineage BA.4 and BA.5.

In a clinical study C4591048 (Study 6) in participants 6 through 23 months of age who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (3 mcg modRNA), adverse reactions following administration of the vaccine included irritability (18.2%), drowsiness (9.1%), injection site redness (8.3%), decreased appetite (4.5%), fatigue (4.2%), fever (4.2%), pain at the injection site (4.2%), and injection site swelling (4.2%).

In a clinical study C4591048 (Study 6) in participants 2 through 4 years of age who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (3 mcg modRNA), adverse reactions following administration of the vaccine included fatigue (30.6%), pain at the injection site (27.8%), injection site redness (8.3%), diarrhea (5.6%), injection site swelling (2.8%), vomiting (2.8%) headache (2.8%), joint pain (2.8%), and chills (2.8%).

In a clinical study C4591048 (Study 6) in participants 5 through 11 years of age who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (10 mcg modRNA), adverse reactions following administration of the vaccine included pain at the injection site (64.0%), fatigue (40.5%), headache (25.2%), muscle pain (13.5%), joint pain (9.0%), chills (9.0%), injection site redness (7.2%), fever (4.5%), injection site swelling (4.5%), vomiting (3.6%), diarrhea (3.6%), and lymphadenopathy (0.9%).

In a clinical study C4591044 (Study 5) in participants 12 years of age and older who received a booster (fourth dose) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (30 mcg modRNA), adverse reactions following administration of the vaccine included pain at the injection site (68.5%), fatigue (56.4%), headache (41.4%), muscle pain (25.8%), chills (16.9%), joint pain (13.4%), diarrhea (9.6%), fever (7.3%), injection site swelling (5.4%), injection site redness (4.5%), vomiting (1.9%), and lymphadenopathy (0.3%).

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:

  • For original monovalent vaccine, the name on the vial label states: Pfizer-BioNTech COVID-19 Vaccine
  • For bivalent vaccine, the name on the vial label states: Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5)

Please see the Formulation/Presentation Guide for more details.

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.

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