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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular use.

2.1 Preparation for Administration

COMIRNATY Single-Dose Prefilled Syringes for Individuals 65 Years of Age and Older and Individuals 12 Years Through 64 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19:

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Verify that the label on the prefilled syringe states 2025-2026 Formula.
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If prefilled syringe has been frozen, discard.
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Do not shake.
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Remove tip cap by slowly turning the cap counterclockwise while holding the Luer lock and attach a sterile needle. Use immediately. If COMIRNATY cannot be used immediately, it must be used within 4 hours.

COMIRNATY Single-Dose Vials for Individuals 5 Years Through 11 Years of Age with at Least One Underlying Condition that Puts Them at High Risk for Severe Outcomes from COVID-19:

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Verify that the label on the vial states 2025-2026 Formula.
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If vial is frozen, thaw vial in the refrigerator [2ºC to 8ºC (35ºF to 46ºF) for up to 2 hours] or at room temperature [up to 25ºC (77ºF) for 30 minutes] [see How Supplied/Storage and Handling (16)].
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Prior to use, mix by inverting vial gently 10 times. Do not shake.
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Withdraw a single 0.3 mL dose using a sterile needle and syringe.
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Discard vial and any excess volume.

2.2 Administration Information

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. For the prefilled syringe, the vaccine will be a white to off-white suspension and for the vial, the vaccine will be clear to slightly opalescent suspension. Do not administer if vaccine is discolored or contains particulate matter.

Administer the 0.3 mL dose intramuscularly immediately after preparation. For the prefilled syringe, administer the entire volume to deliver a single 0.3 mL dose.

2.3 Vaccination Schedule

COMIRNATY is administered as a single dose for individuals 5 years of age and older.

For individuals previously vaccinated with any COVID-19 vaccine, administer the dose of COMIRNATY at least 2 months after the last dose of COVID-19 vaccine.

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