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Vaccination Schedule

COMIRNATY® (COVID-19 Vaccine, mRNA)
2023-2024 Formula

Teal Plus Icon Information Updates

COMIRNATY® (COVID-19 Vaccine, mRNA) 2023-2024 Formula is administered as a single dose for eligible individuals 12 years of age and older

Single dose of 0.3 mL
(30 mcg)

If previously vaccinated with any COVID-19 vaccine, COMIRNATY should be administered at least 2 months after the last dose of COVID-19 vaccine.

The Centers for Disease Control and Prevention has published considerations related to COVID-19 vaccination for individuals who are moderately to severely immunocompromised (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html).

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For eligibility, dosing schedule, and other important information, please see Full Prescribing Information and Patient Information.

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Reference
    COMIRNATY® (COVID-19 Vaccine, mRNA). Full Prescribing Information. BioNTech Manufacturing GmbH and Pfizer Inc. October 17, 2023.

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

INDICATION

IMPORTANT SAFETY INFORMATION

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INDICATION

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.

Do not administer COMIRNATY® (COVID-19 Vaccine, mRNA) to individuals with a known history of a severe allergic reaction (e.g., anaphylaxis) to any component of COMIRNATY 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 used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of COMIRNATY.

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 COMIRNATY, 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 Centers for Disease Control and Prevention (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, including COMIRNATY. 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 COMIRNATY.

Limitation of Vaccine Effectiveness

COMIRNATY may not protect all vaccine recipients.

Adverse Reactions

The most commonly reported adverse reactions (≥10%) after a dose of COMIRNATY were pain at the injection site (up to 90.5%), fatigue (up to 77.5%), headache (up to 75.5%), chills (up to 49.2%), muscle pain (up to 45.5%), joint pain (up to 27.5%), fever (up to 24.3%), injection site swelling (up to 11.8%), and injection site redness (up to 10.4%).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or https://www.pfizersafetyreporting.com or VAERS at 1-800-822-7967 or http://vaers.hhs.gov

Please click for COMIRNATY Full Prescribing Information and Patient Information.


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COMIRNATY (COVID-19 Vaccine, mRNA) PRESCRIBING INFORMATION: UPDATED 10/17/23

COMIRNATY Single dose Glass Prefilled Syringes 2023-2024 Formula Now Available

  • DO NOT FREEZE. COMIRNATY Single Dose Glass Prefilled Syringes are stored in the refrigerator.
  • If glass prefilled syringe has been frozen, discard.
  • Do not shake.
  • Refrigerator-stable for up to 6 months from date of manufacture to the expiration date printed on the carton and on the syringe labels.
  • Ready to use. Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle.
  • See COMIRNATY Full Prescribing Information for Preparation for Administration and Storage Prior to Use.

2023-2024 FORMULA FDA APPROVED: Effective 09/11/23

COMIRNATY® (COVID-19 Vaccine, mRNA) 2023-2024 FORMULA IS FDA APPROVED 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.

Click to view the Full Prescribing Information and Patient Information.

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

  • Please verify that vial labels or prefilled syringes state COMIRNATY® (COVID-19 Vaccine, mRNA) 2023-2024 Formula.
  • Verify the prefilled syringe or vial cap color and label are for the 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.

Regardless of storage condition, the vaccine should not be used after the expiration date printed on the vials, prefilled syringes, and cartons.

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

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