Vaccine Information: Comirnaty

COMIRNATY- tozinameran injection, suspension
COMIRNATY- raxtozinameran 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

​ COMIRNATY Single Dose Vials

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Verify that the vial states 2023-2024 Formula.

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Thaw vial in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)].

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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.

​ COMIRNATY Single Dose Prefilled Syringes

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Thaw syringe in the carton in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)]. Do not remove syringe from carton to thaw.

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Do not shake.

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Remove tip cap and attach a sterile needle.

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.

3 DOSAGE FORMS AND STRENGTHS

COMIRNATY is a suspension for injection. A single dose 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 COMIRNATY [see Description (11)] or to individuals who had a severe allergic reaction (e.g., anaphylaxis) following a previous dose of a Pfizer-BioNTech COVID-19 vaccine.

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 ​with authorized or approved mRNA COVID-19 vaccines demonstrate increased risks of myocarditis and pericarditis, particularly within ​the first week following ​vaccination.​ For COMIRNATY, 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 Centers for Disease Control and Prevention (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 COMIRNATY [see Use in Specific Populations (8.6)].

5.5 Limitation of Effectiveness

COMIRNATY may not protect all vaccine recipients.

6 ADVERSE REACTIONS

An overview of clinical studies contributing to the safety assessment of COMIRNATY is provided in Table 1. Participants in these clinical studies received a 2-dose series, 3 weeks apart (referred to as a primary series) and subsequent doses referred to as booster doses.

Table 1: Clinical Studies

Abbreviation: SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2.
* COMIRNATY encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original). † Received COMIRNATY during placebo-control period. ‡ Vaccine encoding the viral spike (S) glycoprotein of SARS-CoV-2 Wuhan-Hu-1 strain (Original) and Omicron variant lineages BA.4 and BA.5 (Omicron BA.4/BA.5), authorized as Pfizer-BioNTech COVID-19 Vaccine, Bivalent.
Study	Age Group	Vaccine Strain Composition	Dosing	Number of Participants
Primary Series
Study 1 (NCT04380701)	18 through 55 years	Original *	Primary series	60
Study 2 (NCT04368728)	12 through 15 years of age	Original *	Primary series	1131†
	≥16 years of age	Original *	Primary series	22026†
Booster Dose
Study 2 (NCT04368728)	12 through 15 years of age	Original *	1st booster	825
	18 through 55 years of age	Original *	1st booster	306
Study 4 (NCT04955626)	12 through 17 years of age	Original *	1st booster	65
	≥16 years of age	Original *	1st booster	5081†
Study 5 (NCT05472038)	≥12 years of age	Original and Omicron BA.4/BA.5‡	2nd booster	726

Primary Series with COMIRNATY

Participants 12 through 15 years of age in Study 2: the most commonly reported adverse reactions (≥8%) 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%).

Participants 16 through 55 years of age in Study 2: the most commonly reported adverse reactions (≥10%) 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%).

Participants 56 years of age and older in Study 2: the most commonly reported adverse reactions (≥10%) 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%).

Booster Dose with COMIRNATY

Participants 12 years of age and older in Studies 2 and 4: the most commonly reported adverse reactions (≥5%) following administration of a first booster dose with COMIRNATY were similar to those reported by participants who received COMIRNATY in the primary series.

Booster Dose With Pfizer-BioNTech COVID-19 Vaccine, Bivalent

Participants 12 years of age and older in Study 5: the most commonly reported adverse reactions (≥5%) following administration of a second booster dose with Pfizer-BioNTech COVID-19 Vaccine, Bivalent were pain at the injection site (67.3%), fatigue (52.6%), headache (40.5%), muscle pain (24.6%), chills (18.0%), joint pain (13.3%), fever (5.3%), injection site swelling (5.3%), and injection site redness (5.3%).