Viral vaccines
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Comirnaty Dosage

Drug Detail:Comirnaty (Covid-19 vaccine, mrna)

Generic Name: TOZINAMERAN 0.225mg in 2.25mL

Dosage Form: injection, suspension

Drug Class: Viral vaccines

Contents
Uses Warnings Before Taking Dosage Side effects Interactions

For intramuscular injection only.

​The storage, preparation, and administration information in this Prescribing Information apply to COMIRNATY supplied in:

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​single dose vials with gray caps and labels with gray borders, and
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​multiple dose vials with gray caps and labels with gray borders.

​COMIRNATY supplied in vials with gray caps and labels with gray borders MUST NOT be diluted prior to use.

Preparation for Administration

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​COMIRNATY vials with gray caps and labels with gray borders contain a frozen suspension without preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
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​Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)].
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​Refer to thawing and preparation instructions in the panels below.
Preparation Instructions

COMIRNATY Vial with Gray Cap and Label with Gray Border –
Vial Verification
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Verify that the vial of COMIRNATY has a gray cap and a label with a gray border.

✔ Gray cap and label with gray border.

Thawing Prior to Use
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Thaw vial(s) of COMIRNATY before use either by:
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Allowing vial(s) to thaw in the refrigerator [2°C to 8°C (35°F to 46°F)].
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A carton of 10 single dose vials may take up to 2 hours to thaw.
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A carton of 10 multiple dose vials may take up to 6 hours to thaw.
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Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes.
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Thawed vials can be stored in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 10 weeks prior to use.
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Thawed vials may be stored at room temperature [up to 25°C (77°F)] for up to 12 hours prior to use.

Store in the refrigerator for up to 10 weeks prior to use.
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Before use, mix by inverting vaccine vial gently 10 times.
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Do not shake.
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Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles.
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After mixing, the vaccine should appear as a white to off-white suspension with no visible particles.
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Do not use if liquid is discolored or if particles are observed after mixing.

Gently × 10

Preparation of Individual 0.3 mL Doses
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Single Dose Vial

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Withdraw a single 0.3 mL dose of COMIRNATY vaccine.
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Administer immediately.
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Discard vial and any excess volume.

Multiple Dose Vial

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Multiple dose vials contain 6 doses of 0.3 mL each.
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Withdraw 0.3 mL of COMIRNATY preferentially using low dead-volume syringes and/or needles. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial.
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Administer immediately.
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If the amount of vaccine remaining in a multiple dose vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.

Withdraw 0.3 mL dose of vaccine.

Multiple Dose Vial – Record Date and Time of First Puncture
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Record the date and time of first vial puncture on the COMIRNATY multiple dose vial label.
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Store between 2°C to 25°C (35°F to 77°F).
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Discard any unused vaccine 12 hours after first puncture.

Record the date and time of first puncture.
Use within 12 hours after first puncture.

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.

​After withdrawing a single 0.3 mL dose of COMIRNATY, administer immediately.

Vaccination Schedule

COMIRNATY is administered intramuscularly as a series of 2 doses (0.3 mL each) 3 weeks apart.

There are no data available on the interchangeability of COMIRNATY with COVID-19 vaccines from other manufacturers to complete the vaccination series. Individuals who have received 1 dose of COMIRNATY should receive a second dose of COMIRNATY to complete the vaccination series.

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