Comirnaty Dosage
Generic name: TOZINAMERAN 0.225mg in 2.25mL
Dosage form: injection, suspension
Drug class: Viral vaccines
Medically reviewed by Drugs.com. Last updated on Aug 19, 2022.
For intramuscular injection only.
Preparation for Administration
The storage, preparation, and administration information in this Prescribing Information apply to COMIRNATY for individuals 12 years of age and older supplied in multiple dose vials with gray caps and labels with gray borders, which MUST NOT be diluted prior to use.
Age Range | Dilution Information | Doses Per Vial | Dose Volume |
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12 years and older | Do not dilute prior to use | 6 | 0.3 mL |
DO NOT DILUTE
- COMIRNATY multiple dose vial with a gray cap and label with a gray border contains a volume of 2.25 mL, supplied as a frozen suspension that does not contain preservative. Each vial must be thawed prior to administration. DO NOT DILUTE prior to use.
- Vials may be thawed in the refrigerator [2°C to 8°C (35°F to 46°F)] or at room temperature [up to 25°C (77°F)] [see How Supplied/Storage and Handling (16)].
- Refer to thawing instructions in the panels below.
- One vial contains 6 doses of 0.3 mL.
Preparation Instructions | |
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COMIRNATY Multiple Dose Vial with Gray Cap and Label with Gray Border – Vial Verification |
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✔ Gray plastic cap and label with gray border. | |
COMIRNATY Multiple Dose Vial with Gray Cap and Label with Gray Border – Thawing Prior to Use |
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Gently × 10 | |
COMIRNATY Multiple Dose Vial with Gray Cap and Label with Gray Border – Preparation of Individual 0.3 mL Doses |
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Withdraw 0.3 mL dose of vaccine. | |
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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.
Administer a single 0.3 mL dose of COMIRNATY intramuscularly.
Vials of COMIRNATY with gray caps and labels with gray borders contain 6 doses of 0.3 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 6 doses from a single vial. Irrespective of the type of syringe and needle,
- each dose must contain 0.3 mL of vaccine.
- if the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
- do not pool excess vaccine from multiple vials.
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.
Frequently asked questions
More about Comirnaty (sars-cov-2 mrna (tozinameran) vaccine)
- Check interactions
- Latest FDA alerts (1)
- Side effects
- During pregnancy
- FDA approval history
- Drug class: viral vaccines
Patient resources
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Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.