Preparation for Administration

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SPIKEVAX is supplied in two presentations:

o

multiple-dose vial containing 5.5 mL

o

multiple-dose vial containing 7.5 mL

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SPIKEVAX multiple-dose vials contain a frozen suspension that does not contain a preservative and must be thawed prior to administration.

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Thaw each vial before use following the instructions below.

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After thawing, do not refreeze.

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Swirl vial gently after thawing and between each withdrawal. Do not shake. Do not dilute the vaccine.

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Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

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SPIKEVAX is a white to off-white suspension. It may contain white or translucent product-related particulates. Do not administer if vaccine is discolored or contains other particulate matter.

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Each dose is 0.5 mL.

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If the amount of vaccine remaining in the vial cannot provide a full dose of 0.5 mL, discard the vial and contents. Do not pool excess vaccine from multiple vials.

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After the first dose has been withdrawn, the vial should be held between 2°C to 25°C (36°F to 77°F). Record the date and time of first use on the SPIKEVAX vial label. Discard vial after 12 hours. Do not refreeze.

Administration

Administer a single 0.5 mL dose.

Dosing and Schedule

SPIKEVAX is administered intramuscularly as a series of two doses (0.5 mL each) 1 month apart.

There are no data available on the interchangeability of SPIKEVAX with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received one dose of SPIKEVAX should receive a second dose of SPIKEVAX to complete the vaccination series.