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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 Preparation for Administration

COMIRNATY Single Dose Glass Prefilled Syringes

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Verify that the glass prefilled syringe states 2024-2025 Formula.
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If glass 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

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Verify that the vial states 2024-2025 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. The vaccine will be a white to off-white 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 12 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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