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5 through 11 years of age

Pfizer-BioNTech COVID-19 Vaccine

FDA AUTHORIZED FOR EMERGENCY USE1-3

Emergency uses of Pfizer-BioNTech COVID-19 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 aged 6 months 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.

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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 5 THROUGH 11 YEARS, DILUTE BEFORE USE

5 THROUGH 11 YEARS OF AGE, DILUTE BEFORE USE (ORANGE CAP)

Storage & Handling Dosing & Preparation Resources
References
  1. 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.
  2. 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.
  3. 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.

Indication & Authorized Use

INDICATION AND 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
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 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 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

Postmarketing data with Pfizer-BioNTech COVID-19 Vaccine demonstrate increased risks of myocarditis and pericarditis, particularly within the period 0 through 7 days following the second dose of the primary series. 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.

Adverse Reactions

Primary Series Adverse Events:

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%) 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%).

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.

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 the vaccine.

EUA Fact Sheet for Vaccination Providers

5 through 11 years of age - Monovalent Primary Series - Orange Cap 12 years of age and older - Monovalent Primary Series - Gray Cap 12 years of age and older - Monovalent Primary Series - Purple 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

5 through 11 years of age
12 years of age and older


For More Information

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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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