Vaccine Information: Comirnaty

COMIRNATY- tozinameran injection, suspension
Pfizer Laboratories Div Pfizer Inc

1 INDICATIONS AND USAGE

COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.

2 DOSAGE AND ADMINISTRATION

For intramuscular injection only.

2.1 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.

COMIRNATY Multiple Dose Vial with a Gray Cap and Label with a Gray Border
Age RangeDilution InformationDoses Per VialDose Volume
12 years and olderDo not dilute prior to use60.3 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
COMIRNATY Multiple Dose Vial with Gray Cap and Label with Gray Border – Vial Verification

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  • Verify that the vial of COMIRNATY has a gray plastic cap and a label with a gray border.
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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  • Thaw vial(s) of COMIRNATY before use either by:
    • Allowing vial(s) to thaw in the refrigerator [2°C to 8°C (35°F to 46°F)]. A carton of 10 vials may take up to 6 hours to thaw, and thawed vials can be stored in the refrigerator for up to 10 weeks.
    • Allowing vial(s) to sit at room temperature [up to 25°C (77°F)] for 30 minutes.
  • Vials may be stored at room temperature [up to 25°C (77°F)] for up to 12 hours prior to use.
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  • Before use, mix by inverting vaccine vial gently 10 times.
  • Do not shake.
  • Prior to mixing, the thawed vaccine may contain white to off-white opaque amorphous particles.
  • After mixing, the vaccine should appear as a white to off-white suspension with no visible particles.
  • Do not use if liquid is discolored or if particles are observed after mixing.
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 of COMIRNATY preferentially using low dead-volume syringes and/or needles.
  • Each dose must contain 0.3 mL of vaccine.
  • If the amount of vaccine remaining in a single vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
  • Administer immediately.
Withdraw 0.3 mL dose of vaccine.
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  • Record the date and time of first vial puncture on the COMIRNATY vial label.
  • Store between 2°C to 25°C (35°F to 77°F).
  • Discard any unused vaccine 12 hours after first puncture.
Record the date and time of first puncture. Use within 12 hours after first puncture.

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 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.

2.3 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.

3 DOSAGE FORMS AND STRENGTHS

COMIRNATY is a suspension for injection. Each dose of COMIRNATY supplied in vials with gray caps and labels with gray borders is 0.3 mL.

4 CONTRAINDICATIONS

Do not administer COMIRNATY to individuals with known history of a severe allergic reaction (e.g., anaphylaxis) to any component of the COMIRNATY [see Description (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Management of Acute Allergic Reactions

Appropriate medical treatment used to manage immediate allergic reactions must be immediately available in the event an acute anaphylactic reaction occurs following administration of COMIRNATY.

5.2 Myocarditis and Pericarditis

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 12 through 17 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

5.3 Syncope

Syncope (fainting) may occur in association with administration of injectable vaccines, including COMIRNATY. Procedures should be in place to avoid injury from fainting.

5.4 Altered Immunocompetence

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the COMIRNATY.

5.5 Limitation of Effectiveness

COMIRNATY may not protect all vaccine recipients.

6 ADVERSE REACTIONS

In clinical studies, the most commonly reported (≥10%) adverse reactions in participants 16 through 55 years of age following any dose were pain at the injection site (88.6%), fatigue (70.1%), headache (64.9%), muscle pain (45.5%), chills (41.5%), joint pain (27.5%), fever (17.8%), and injection site swelling (10.6%).

In clinical studies, the most commonly reported (≥10%) adverse reactions in participants 56 years of age and older following any dose were pain at the injection site (78.2%), fatigue (56.9%), headache, (45.9%), muscle pain (32.5%), chills (24.8%), joint pain (21.5%), injection site swelling (11.8%), fever (11.5%), and injection site redness (10.4%).

In a clinical study, the most commonly reported (≥8%) adverse reactions in adolescents 12 through 15 years of age following any dose were pain at the injection site (90.5%), fatigue (77.5%), headache (75.5%), chills (49.2%), muscle pain (42.2%), fever (24.3%), joint pain (20.2%), injection site swelling (9.2%), and injection site redness (8.6%).

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