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yellow cap

Yellow Cap

For Individuals 6 Months
Through 4 Years of Age

Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula

Refrigerated Storage Time:
10 Weeks

Dilution:
DILUTE BEFORE USE

Dose:
3 mcg

Dose per vial:
3 doses (after dilution)

Dose volume:
0.3 mL

blue cap

Blue Cap

For Individuals 5
Through 11 Years of Age

Pfizer-BioNTech COVID-19 Vaccine 2023-2024 Formula

Refrigerated Storage Time:
10 Weeks

Dilution:
DO NOT DILUTE

Dose:
10 mcg

Dose per vial:
Single dose

Dose volume:
0.3 mL

Dose Preparation & Administration1

Step 1: Verify Vials


Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) is a suspension for injection, for intramuscular use only.

During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

There are two presentations of the Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula):

orange-vial-icon

Yellow Cap

6 months through 4 years of age

DILUTE BEFORE USE

  • Multiple dose vials for individuals 6 months through 4 years of age have yellow caps and labels with yellow borders.
  • Yellow cap vials are supplied in a carton of 10 multiple dose vials.
  • Each multiple dose vial contains 3 doses of 0.3 mL per dose (after dilution).

blue-vial-icon

Blue Cap

5 through 11 years of age

DO NOT DILUTE

  • Single dose vials for individuals 5 through 11 years of age have blue caps and labels with blue borders.
  • Blue cap vials are supplied in a carton of 10 single dose vials.
  • Each single dose vial contains 1 dose of 0.3 mL (no dilution required).

Step 2:
Thaw Vials (If Frozen)


If vials are frozen, they must be thawed prior to use. Vials can be thawed in one of two ways:

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Thaw in the refrigerator

at 2°C to 8°C (35°F to 46°F)

May take up to 2 hours to thaw at this temperature.


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Thaw at room temperature for 30 min

up to 25°C (77°F)

Storage and Expiration for Vials

Verify that product has not expired. When stored at ULT, yellow and blue cap vials should be used within 12 months. When stored in a refrigerator, yellow and blue cap vials should be used within 10 weeks. Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials and cartons.

Thawed vials can be stored in the refrigerator [2°C to 8°C (35°F to 46°F)] for 10 weeks* and at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After dilution, multiple dose vials should be held between 2°C to 25°C (35°F to 77°F) and discarded after 12 hours.

*The 10-week refrigerated expiry date should be recorded on the carton and should not exceed the expiration date printed on the vial and cartons.

Step 3: Preparation


Check the contents of the vaccine during preparation and right before use. The liquid should be clear to slightly opalescent with no visible particles. Do not use if liquid is discolored or if other particles are observed.

orange-vial-icon

Yellow Cap

6 months through 4 years of age

DILUTE BEFORE USE

  • Add 1.1 mL sterile 0.9% Sodium Chloride Injection, USP into vaccine vial.
  • Before removing needle from vial, equalize vial pressure by withdrawing air into empty diluent syringe.
  • After dilution, mix by inverting thawed vial gently 10 times. Never shake the vials or vaccine.
  • Record date and time of dilution on vial label.
  • After dilution, multiple dose vials contain 3 doses of 0.3 mL each.
  • Store at 2°C to 25°C (35°F to 77°F) and discard after 12 hours.

NOTE: If amount of vaccine in vial cannot provide a full dose of 0.3 mL, discard vial and any excess volume. Do not pool excess vaccine from multiple vials.


blue-vial-icon

Blue Cap

5 through 11 years of age

DO NOT DILUTE

  • Prior to use, mix by inverting thawed vial gently 10 times. Never shake the vials or vaccine.
  • Withdraw a single 0.3 mL dose.
  • Discard single dose vial and any excess volume.

Step 4:
Administration


syringe-icon syringe-icon
  • Visually inspect for particulate matter and discoloration prior to administration.
  • Vaccine should be clear to slightly opalescent suspension.
  • DO NOT ADMINISTER if vaccine is discolored or contains particulate matter.

Administer a single 0.3 mL dose intramuscularly.

Ensuring the Authenticity and Registered Trademark Name COMIRNATY® (COVID-19 Vaccine, mRNA) 2023-2024 Formula

  • Pfizer is committed to patient safety and ensuring that people have accurate information about the vaccines, including how they are accessed and administered. We are actively monitoring for fraudulent offers of illegitimate vaccines to protect patients from products that might be dangerous and lead to serious and life-threatening harm.
    • The vaccines are only administered intramuscularly by a healthcare professional1
    • The vaccines are not taken orally and are not available in a capsule or tablet form1
  • Authentic vaccines, manufactured by Pfizer Inc., will include the Pfizer and BioNTech names on the label and can be visually verified via this page.
  • Ensure the security of the vaccine vials and prefilled syringes by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials and prefilled syringes in sharps containers and empty vaccine cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through established medical centers—such as doctor’s offices, pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals or other individuals who are approved vaccinators. Individual doses are not for sale.2,3
  • Ensure the security of the vaccine vials by limiting access to only authorized personnel. The location they are stored in must be secure and locked when not in use. To prevent counterfeits, discard vaccine vials in sharps containers and empty vial cartons as medical waste or deface or safely crush all materials so they cannot be reused. Remember, the vaccines are only available through established medical centers—such as doctor’s offices, pharmacies, outpatient clinics, community vaccination locations, and hospitals. The vaccines can only be administered by licensed healthcare professionals or other individuals who are approved vaccinators. Individual doses are not for sale.2,3

If you suspect the vaccine you have purchased may be counterfeit, contact us at 1-800-438-1985 or visit https://www.pfizer.com/products/product-contact-information.

To learn more, visit https://www.pfizer.com/products/medicine-safety/counterfeiting.

*The 10-week refrigerated expiry date should be recorded on the carton and should not exceed the expiration date printed on the vial and cartons.

References

  1. Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) Emergency Use Authorization Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) (6 months through 11 years of age); BioNTech Manufacturing GmbH and Pfizer Inc.; December 08, 2023.
  2. Centers for Disease Control and Prevention. COVID-19 Vaccination Program Interim Operational Guidance Jurisdiction Operations. Version 2.0. October 29, 2020. Accessed October 02, 2023. https://www.cdc.gov/vaccines/imz-managers/downloads/covid-19-vaccination-program-interim_playbook.pdf
  3. U.S. Department of Defense. Memorandum: Secure disposal of vaccine vials and packaging recommendations. February 02, 2021.

Eligible healthcare providers can order COVID-19 vaccines directly from Pfizer*

Learn about ordering vaccines through Pfizer
Prime online or by calling 1-800-533-4535.

*If preferred, orders may be placed with your facility's
wholesaler. All vaccine presentations may not be available directly through Pfizer.

IMPORTANT SAFETY INFORMATION

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AUTHORIZED USE

Indication & Authorized Use

IMPORTANT SAFETY INFORMATION

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Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.

Important Safety Information

Do not administer Pfizer-BioNTech COVID-19 Vaccine to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the Pfizer-BioNTech COVID-19 Vaccine or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

Management of Acute Allergic Reactions

Appropriate medical treatment 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.

Monitor Pfizer-BioNTech COVID-19 Vaccine recipients for the occurrence of immediate adverse reactions according to the Centers for Disease Control and Prevention (CDC) guidelines (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).

Myocarditis and Pericarditis

Postmarketing data with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within the first week following vaccination. For the Pfizer-BioNTech COVID-19 Vaccine, 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. Procedures should be in place to avoid injury from fainting.

Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished response to Pfizer-BioNTech COVID-19 Vaccine.

Limitation of Vaccine Effectiveness

Pfizer-BioNTech COVID-19 Vaccine may not protect all vaccine recipients.

Adverse Reactions

Solicited adverse reactions included:

  • 6 months through 23 months of age: Injection site redness; swelling and tenderness; decreased appetite; drowsiness; fever; irritability.
  • 2 through 11 years of age: Injection site pain; redness and swelling; chills; diarrhea; fatigue; fever; headache; new or worsened joint pain; new or worsened muscle pain; vomiting.

Vaccination providers must report all vaccine administration errors, all serious adverse events, cases of myocarditis, cases of pericarditis, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death following administration of Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) to the Vaccine Adverse Event Reporting System (VAERS) by submitting online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words “Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) EUA” in the description section of the report. To the extent feasible, report adverse events to Pfizer 1-800-438-1985 or provide a copy of the VAERS form to Pfizer https://
www.pfizersafetyreporting.com/

Please click for Pfizer-BioNTech COVID-19 Vaccine Vaccination Provider and
Recipient and Caregiver EUA Fact Sheets.

AUTHORIZED USE

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) 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 through 11 years of age.


For More Information

Pfizer Customer Service

Call 1-800-879-3477

Medical Information

Visit PfizerMedicalInformation.com

Shipment Support
U.S. Trade Customer Service

Call 1-800-666-7248

General Product Inquiries

Call 1-800-879-3477

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Call 1-844-966-5127

Emergency Use Authorization
(EUA)

Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 6 months through 11 years of age. The emergency use of this product is 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.

AUTHORIZED: Effective 09/11/23

PFIZER-BIONTECH COVID-19 VACCINE (2023-2024 FORMULA) IS AUTHORIZED FOR EMERGENCY USE 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 THROUGH 11 YEARS OF AGE.

Click to view the EUA Fact Sheet for Vaccination Providers.

To prevent vaccine administration errors, prior to preparation and administration:

  • Please verify that vial labels state Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula)
  • Verify the vial cap color and label for the respective appropriate age group.

Please see the Formulation/Presentation Guide for more details.

Important Reminder:

Previous COVID-19 vaccines, including original monovalent COVID-19 vaccines and bivalent (original and Omicron BA.4/BA.5) mRNA COVID-19 vaccines are no longer authorized for use in the United States.

FDA and CDC guidance is to check inventory and dispose of previous COVID-19 vaccines according to state and local regulations.

If cartons are received refrigerated at 2°C to 8°C (35°F to 46°F), they should be stored in a refrigerator at 2°C to 8°C (35°F to 46°F). Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vial and cartons.


Read the Important Safety Information below and check back for
further updates.

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