Comirnaty (COVID-19 Vaccine, mRNA)

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Health Canada has granted full approval (Notice of Compliance or NOC) for COMIRNATY (COVID-19 Vaccine, mRNA) to prevent COVID-19 in individuals 5 years of age and older.

COMIRNATY (COVID-19 Vaccine, mRNA) and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap) cannot be used to prepare doses for individuals aged 5 years to <12 years.

Vials of COMIRNATY intended for individuals aged 5 years to <12 years (orange cap) cannot be used to prepare doses for individuals 12 years of age and older.

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

Comirnaty (COVID-19 Vaccine, mRNA) Quick Finder

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Product Monograph

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Note: the information below includes the Part I: Health Professional Information.

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1 Health Professional Information

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2 Contraindications

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3 Serious Warnings And Precautions

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4 Dosage And Administration

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4.1 Dosing Considerations

The storage, preparation and administration information differ depending on which presentation of the vaccine is considered. Careful attention should be paid to the vial cap and label border colour and the appropriate corresponding instructions must be followed under the subsections below.

For 12 Years of Age and Older
COMIRNATY is a suspension for intramuscular injection. There are two formulations of COMIRNATY authorized for use in individuals 12 years of age and older.

DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)
DO NOT DILUTE (Vials with Gray Cap and Gray Label Border)

After preparation, a single dose is 0.3 mL.

For Age 5 Years to <12 Years
COMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration.

DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border)

After preparation, a single dose is 0.2 mL.

Dosage Form	Vial Cap and Label Border Colour	Age Range	Dilution Information	Doses Per Vial	Dose Volume
* May be labeled as Pfizer-BioNTech COVID-19 vaccine
COMIRNATY* Multiple Dose Vial (for 12 years of age and older: DILUTE BEFORE USE)	Purple	12 years and older	Dilute with 1.8 mL 0.9% Sodium Chloride Injection, USP prior to use	6	0.3 mL
COMIRNATY* Multiple Dose Vial (for 12 years of age and older: DO NOT DILUTE)	Gray	12 years and older	DO NOT DILUTE prior to use	6	0.3 mL
COMIRNATY* Multiple Dose Vial (for age 5 years to <12 years: DILUTE PRIOR TO USE)	Orange	5 to <12 years	Dilute with 1.3 mL 0.9% Sodium Chloride Injection, USP prior to use	10	0.2 mL

4.2 Recommended Dose and Dosage Adjustment

4.2.1 Vaccination Schedule for Individuals 12 Years of Age and Older

COMIRNATY is administered intramuscularly as a primary series of two doses (0.3 mL each) 3 weeks apart in individuals 12 years of age and older.
A booster dose of COMIRNATY (0.3 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 18 years of age or older.

There are currently no data available from Pfizer and BioNTech clinical trials on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose.

When prepared according to their respective instructions, COMIRNATY for 12 years of age and older (DILUTE BEFORE USE: purple cap and purple label border) and COMIRNATY for 12 years of age and older (DO NOT DILUTE: gray cap and gray label border) can be used interchangeably to provide the COVID-19 vaccination series.

COMIRNATY and the Interim Order authorized Pfizer-BioNTech COVID-19 Vaccine, for use in individuals 12 years of age and older, have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series.

Vials of COMIRNATY intended for individuals 12 years of age and older (purple cap/purple label border or gray cap/gray label border) cannot be used to prepare doses for individuals aged 5 years to <12 years.

4.2.2 Vaccination Schedule for Individuals Aged 5 Years to <12 Years

COMIRNATY is administered intramuscularly as a series of two doses (0.2 mL each) 3 weeks apart.

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

Vials of COMIRNATY intended for individuals aged 5 years to <12 years (orange cap/orange label border) cannot be used to prepare doses for individuals 12 years of age and older.

4.3 Reconstitution

4.3.1 For 12 Years of Age and Older

Two formulations of COMIRNATY are available for individuals 12 years of age and older.

4.3.1.1 For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)

Preparation for Administration

Prior to Dilution:

The COMIRNATY multiple dose vial with a purple cap and purple label border contains a volume of 0.45 mL. It is supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration.
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 11 STORAGE, STABILITY AND DISPOSAL).
Prior to dilution, the thawed suspension may contain white to off-white opaque amorphous particles.
Refer to thawing instructions in the panels below.

Dilution:

Dilute the vial contents using 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Do not add more than 1.8 mL of diluent.
ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.
After dilution, one vial contains 6^† doses of 0.3 mL.
After dilution, the vaccine will be an off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.
Strict adherence to aseptic techniques must be followed.
Refer to dilution and dose preparation instructions in the panels below.

†: 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 a 6^th dose from a single vial.

For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border) VIAL AND DOSE VERIFICATION
	Verify that the vial has a purple plastic cap and purple label border. If the vial has a gray plastic cap and gray label border, refer to the preparation instructions for 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border). If the vial has an orange plastic cap and orange label border, do not use to prepare doses for individuals 12 years of age and older.
For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border) THAWING PRIOR TO DILUTION
	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 vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to 1 month. Allowing vial(s) to sit at room temperature (up to 25°C [77°F]) for 30 minutes. Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours of exposure to room temperature.
	Before dilution, invert vaccine vial gently 10 times. Do not shake. Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Do not use if liquid is discoloured or if other particles are observed.
For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border) DILUTION
	Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. Using aseptic technique, withdraw 1.8 mL of 0.9% Sodium Chloride Injection, USP into a transfer syringe (using 21-gauge or narrower needle). Cleanse the vaccine vial stopper with a single-use antiseptic swab. Add 1.8 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial.
	Equalize vial pressure before removing the needle from the vial by withdrawing 1.8 mL air into the empty diluent syringe.
	Gently invert the vial containing COMIRNATY 10 times to mix. Do not shake. Inspect the vaccine in the vial. The vaccine will be an off-white suspension. Do not use if vaccine is discoloured or contains particulate matter.
	Record the date and time of first vial puncture (dilution) on the COMIRNATY vial label. Store between 2°C to 25°C (35°F to 77°F). Do not freeze or shake the diluted vaccine. If refrigerated, allow the diluted vaccine to come to room temperature prior to use.

For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border) PREPARATION OF INDIVIDUAL 0.3 mL DOSES
	Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and 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 the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume. Administer immediately, and no later than 6 hours after dilution. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction.

For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)

PREPARATION OF INDIVIDUAL 0.3 mL DOSES

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and 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 the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
Administer immediately, and no later than 6 hours after dilution.
Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction.

4.3.1.2 For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border)

The COMIRNATY multiple dose vial with a gray cap and gray label border MUST NOT BE DILUTED prior to administration. Instructions on the handling and dose preparation of the vaccine prior to administration are provided below.

Preparation for Administration
DO NOT DILUTE

The COMIRNATY multiple dose vial with a gray cap and a gray label border contains a volume of 2.25 mL, and is 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 11 STORAGE, STABILITY AND DISPOSAL).
The thawed suspension may contain white to off-white opaque amorphous particles.
One vial contains 6^† doses of 0.3 mL.
Refer to thawing and dose preparation instructions in the panels below.

†: 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 a 6^th dose from a single vial.

For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border) VIAL AND DOSE VERIFICATION
	Verify that the vial has a gray plastic cap and gray label border. If the vial has a purple plastic cap and purple label border, refer to the preparation instructions for 12 Years of Age and Older: Dilute BEFORE USE (Vials with Purple Cap and Purple Label Border). If the vial has an orange plastic cap and orange label border, do not use to prepare doses for individuals 12 years of age and older. The date printed on the vial and carton reflects the date of manufacture. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton.
For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border) THAWING PRIOR TO USE
	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.
	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 discoloured or if particles are observed after mixing.
For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border) PREPARATION OF INDIVIDUAL 0.3 mL DOSES
	Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of COMIRNATY (for 12 years of age and older) preferentially using a low dead-volume syringe and/or 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. Administer immediately and no later than 12 hours after first puncture. Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction.
	Record the date and time of first vial puncture on the vial label. Store between 2°C to 25°C (35°F to 77°F). Discard any unused vaccine 12¹ hours after first puncture.

1: Vial labels and cartons may state that a vial should be discarded 6 hours after first use. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons.

4.3.2 For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border)

Preparation for Administration

Prior to Dilution:

The COMIRNATY multiple dose vial (for ages 5 years to <12 years) has an orange cap and an orange label border and contains a volume of 1.3 mL. It is supplied as a frozen suspension that does not contain preservative. Each vial must be thawed and diluted prior to administration.
Vials of COMIRNATY intended for 12 years or age or older with a purple cap/purple label border or gray cap/gray label border cannot be used to prepare doses for individuals aged 5 years to <12 years.
Vials may be thawed in the refrigerator at 2°C to 8°C [35°F to 46°F] or at room temperature (up to 25°C [77°F]) (see 11 STORAGE, STABILITY AND DISPOSAL).
Prior to dilution, the thawed suspension may contain opaque amorphous particles.
Refer to thawing instructions in the panels below.

Dilution:

Dilute the vial contents using 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Do not add more than 1.3 mL of diluent.
ONLY use 0.9% Sodium Chloride Injection, USP as the diluent. This diluent is not packaged with the vaccine and must be sourced separately. Do not use bacteriostatic 0.9% Sodium Chloride Injection or any other diluent.
After dilution, one vial contains 10^* doses of 0.2 mL.
After dilution, the vaccine will be a white to off-white suspension. Inspect vials to confirm there are no particulates and no discolouration is observed.
Strict adherence to aseptic techniques must be followed.
Refer to dilution and dose preparation instructions in the panels below.

*: Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial.

For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border) VIAL AND DOSE VERIFICATION
	Verify that the vial has an orange plastic cap and an orange label border. Do not use COMIRNATY vials with a purple cap/purple label border or gray cap/gray label border to prepare doses for individuals aged 5 years to <12 years. The date printed on the vial and carton reflects the date of manufacture. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton.

For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border)

VIAL AND DOSE VERIFICATION

Verify that the vial has an orange plastic cap and an orange label border. Do not use COMIRNATY vials with a purple cap/purple label border or gray cap/gray label border to prepare doses for individuals aged 5 years to <12 years.
The date printed on the vial and carton reflects the date of manufacture. The vaccine should not be used after 12 months from the date of manufacture printed on the vial and carton.

THAWING PRIOR TO DILUTION
	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 4 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 dilution.
	Before dilution, allow the thawed vial to come to room temperature. When at room temperature, mix by inverting vaccine vial gently 10 times. Do not shake. Inspect the liquid in the vial prior to dilution. The liquid is a white to off-white suspension and may contain white to off-white opaque amorphous particles. Do not use if liquid is discoloured or if other particles are observed.
DILUTION
	Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. Using aseptic technique, withdraw 1.3 mL of diluent into a transfer syringe (using 21‑gauge or narrower needle). Cleanse the vaccine vial stopper with a single‑use antiseptic swab. Add 1.3 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial.
	Equalize vial pressure before removing the needle from the vial by withdrawing 1.3 mL air into the empty diluent syringe.
	Gently invert the vial containing COMIRNATY 10 times to mix. Do not shake. Inspect the vaccine in the vial. The vaccine will be a white to off-white suspension. Do not use if vaccine is discoloured or contains particulate matter.
	Record the date and time of first vial puncture (dilution) on the COMIRNATY (for age 5 years to <12 years) vial label. Store between 2°C to 25°C (35°F to 77°F). Do not freeze or shake the diluted vaccine. If refrigerated, allow the diluted vaccine to come to room temperature prior to use. Discard any unused vaccine 12¹ hours after dilution.
PREPARATION OF INDIVIDUAL 0.2 mL DOSES
	Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 2 mL of COMIRNATY (for age 5 years to <12 years) preferentially using a low dead-volume syringe and/or needle. Each dose must contain 0.2 mL of vaccine. If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume. Administer immediately, and no later than 12¹ hours after dilution. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction.

1: Vial labels and cartons may state that a vial should be discarded 6 hours after dilution. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons.

4.4 Administration

4.4.1 For 12 Years of Age and Older

Administer a single 0.3 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

Two formulations of COMIRNATY are available for individuals 12 years of age and older.

DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)
After dilution, vials of COMIRNATY (with purple cap and purple label border) contain 6 doses of 0.3 mL of vaccine.
DO NOT DILUTE (Vials with Gray Cap and Gray Label Border)
Vials of COMIRNATY with gray caps and gray label borders contain 6 doses of 0.3 mL of vaccine.

Visually inspect each dose in the dosing syringe prior to administration. The vaccine will be an off white suspension. During the visual inspection:

Verify the final dosing volume of 0.3 mL.
Confirm there are no particulates and that no discolouration is observed.
Do not administer if vaccine is discoloured or contains particulate matter.

Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. In order to ensure consistent withdrawal of 6 doses of 0.3 mL, it is important to adhere to minimizing volume loss during dose extraction. If standard syringes and needles are used, there may not be sufficient volume to extract a 6^thdose 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.

4.4.2 For Age 5 Years to <12 Years

Administer a single 0.2 mL dose of COMIRNATY intramuscularly, preferably in the deltoid muscle.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

DILUTE PRIOR TO USE (Vial with Orange Cap and Orange Label Border).

Visually inspect each dose in the dosing syringe prior to administration. The diluted vaccine will be a white to off white suspension. During the visual inspection:

Verify the final dosing volume of 0.2 mL.
Confirm there are no particulates and that no discolouration is observed.
Do not administer if vaccine is discoloured or contains particulate matter.

After dilution, vials of COMIRNATY (for age 5 years to <12 years) contain 10 doses of 0.2 mL of vaccine. Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. In order to ensure consistent withdrawal of 10 doses of 0.2 mL, it is important to adhere to minimizing volume loss during dose extraction. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial. Irrespective of the type of syringe and needle:

Each dose must contain 0.2 mL of vaccine.
If the amount of vaccine remaining in the vial cannot provide a full dose of 0.2 mL, discard the vial and any excess volume.
Do not pool excess vaccine from multiple vials.

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5 Overdosage

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6 Dosage Forms, Strengths, Composition And Packaging

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To help ensure the traceability of vaccines for patient immunization record-keeping as well as safety monitoring, health professionals should record the time and date of administration, quantity of administered dose (if applicable), anatomical site and route of administration, brand name and generic name of the vaccine, the product lot number and expiry date (or manufacture date).

For 12 Years of Age and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)

COMIRNATY is supplied as a frozen suspension in multiple dose vials. Each vial must be diluted with 1.8 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 6^† doses of 0.3 mL after dilution. Each 0.3 mL dose of COMIRNATY contains 30 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 1 below.

COMIRNATY does not contain preservative. The vial stoppers are not made with natural rubber latex.

COMIRNATY multiple dose vials (with purple cap and purple label border) are supplied in a carton containing 25 multiple dose vials or 195 multiple dose vials. Not all pack sizes may be available.

For 12 Years of Age and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border)

COMIRNATY is supplied as a frozen suspension in multiple dose vials. Do not dilute. Each vial contains 6† doses of 0.3 mL. Each 0.3 mL dose of COMIRNATY contains 30 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 1 below.

COMIRNATY does not contain preservative. The vial stoppers are not made with natural rubber latex.

COMIRNATY multiple dose vials (with gray cap and gray label border) are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Not all pack sizes may be available.

†: 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 a 6th dose from a single vial.

Table 1 – Dosage Forms, Strengths, Composition and Packaging (For 12 Years of Age and Older)
Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
Intramuscular injection	DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border) Suspension (to be diluted before use) Multiple dose vial (after dilution, each vial contains 6^† doses of 0.3 mL)	ALC-0315 = ((4-hydroxybutyl) azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholine cholesterol dibasic sodium phosphate dihydrate monobasic potassium phosphate potassium chloride sodium chloride sucrose water for injection
Intramuscular injection	DO NOT DILUTE (Vials with Gray Cap and Gray Label Border) Suspension (do not dilute) Multiple dose vial (each vial contains 6^† doses of 0.3 mL)	ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate) ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholine cholesterol sodium chloride sucrose tromethamine tromethamine hydrochloride water for injection

For Age 5 Years to < 12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border)

COMIRNATY is supplied as a frozen suspension in multiple dose vials with orange caps and an orange label border. Each vial must be diluted with 1.3 mL of sterile 0.9% Sodium Chloride Injection, USP prior to use to form the vaccine, and contains 10^* doses of 0.2 mL after dilution. Each 0.2 mL dose of COMIRNATY contains 10 mcg of a nucleoside modified messenger RNA (modRNA) encoding the viral spike (S) glycoprotein of SARS-CoV-2 (original strain) and the non-medicinal ingredients listed in Table 2 below.

*: Low dead-volume syringes and/or needles can be used to extract 10 doses from a single vial. If standard syringes and needles are used, there may not be sufficient volume to extract 10 doses from a single vial.

**Table 2 – Dosage Forms, Strengths, Composition and Packaging (For Age 5 Years to <12 Years)**
Route of Administration	Dosage Form / Strength/Composition	Non-medicinal Ingredients
Intramuscular injection	Suspension (to be diluted before use) Multiple dose vial (after dilution, each vial contains 10* doses of 0.2 mL)	ALC-0315 = ((4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate) ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide 1,2-distearoyl-sn-glycero-3-phosphocholine cholesterol sodium chloride sucrose tromethamine tromethamine hydrochloride water for injection

COMIRNATY does not contain preservative. The vial stoppers are not made with natural rubber latex.

COMIRNATY multiple dose vials are supplied in a carton containing 10 multiple dose vials or 195 multiple dose vials. Not all pack sizes may be available.

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7 Warnings And Precautions

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General

The administration of COMIRNATY should be postponed in individuals suffering from acute severe febrile illness.

Fainting may occur in association with administration of injectable vaccines. Individuals should be advised to bring symptoms (e.g., dizziness, increases in heart rate, feeling short of breath, tingling sensations or sweating) to the attention of the vaccination provider for evaluation. Procedures should be in place to avoid injury from fainting.

As with any vaccine, vaccination with COMIRNATY may not protect all recipients.

Individuals may not be optimally protected until at least 7 days after their second dose of vaccine (see 14 CLINICAL TRIALS).

Acute Allergic Reactions

Anaphylaxis has been reported. As with all vaccines, training for immunizers, appropriate medical treatment and supervision after immunization should always be readily available in case of a rare anaphylactic event following the administration of this vaccine.

Vaccine recipients should be kept under observation for at least 15 minutes after immunization; 30 minutes is a preferred interval when there is a specific concern about a possible vaccine reaction.

A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of COMIRNATY.

Cardiovascular

Myocarditis and Pericarditis

Very rare cases of myocarditis and/or pericarditis following vaccination with COMIRNATY have been reported during post-authorization use. These cases occurred more commonly after the second dose and in adolescents and young adults. Typically, the onset of symptoms has been within a few days following receipt of COMIRNATY. Available short-term follow-up data suggest that the symptoms resolve in most individuals, but information on long-term sequelae is lacking. The decision to administer COMIRNATY to an individual with a history of myocarditis or pericarditis should take into account the individual’s clinical circumstances.

Healthcare professionals are advised to consider the possibility of myocarditis and/or pericarditis in their differential diagnosis if individuals present with chest pain, shortness of breath, palpitations or other signs and symptoms of myocarditis and/or pericarditis following immunization with a COVID-19 vaccine. This could allow for early diagnosis and treatment. Cardiology consultation for management and follow up should be considered.

Driving and Operating Machinery

COMIRNATY has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under 8 ADVERSE REACTIONS may temporarily affect the ability to drive or use machines.

Fertility

It is unknown whether COMIRNATY has an impact on fertility. Animal studies do not indicate direct or indirect harmful effects with respect to female fertility or reproductive toxicity (see 16 NON-CLINICAL TOXICOLOGY).

Hematologic

Individuals receiving anticoagulant therapy or those with a bleeding disorder that would contraindicate intramuscular injection should not be given the vaccine unless the potential benefit clearly outweighs the risk of administration.

Immune

Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine. In these individuals, a third dose may be considered as part of the primary series.

7.1 Special Populations

7.1.1 Pregnant Women

The safety and efficacy of COMIRNATY in pregnant women have not yet been established.

Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/ fetal development, parturition, or post-natal development (see 16 NON-CLINICAL TOXICOLOGY).

7.1.2 Breast-feeding

It is unknown whether COMIRNATY is excreted in human milk. A risk to the newborns/infants cannot be excluded.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for immunization against COVID-19.

7.1.3 Pediatrics

The safety and efficacy of COMIRNATY in children under 5 years of age have not yet been established.

7.1.4 Geriatrics

Clinical studies of COMIRNATY include participants 65 years of age and older and their data contributes to the overall assessment of safety and efficacy (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS).

The safety and immunogenicity of a booster dose of COMIRNATY in individuals 65 years of age and older is based on safety and immunogenicity data in adults 18 through 55 years of age (See 8 ADVERSE REACTIONS and 14 CLINICAL TRIALS).

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8 Adverse Reactions

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8.1 Adverse Reaction Overview

The safety of 2 doses of COMIRNATY was evaluated in participants 5 years of age and older in three clinical studies conducted in the United States, Europe, Turkey, South Africa, and South America.

Study BNT162‑01 (Study 1) was a Phase 1/2, two-part dose-escalation trial that enrolled 60 participants 18 through 55 years of age and 36 participants 56 through 85 years of age.

Study C4591001 (Study 2) is a Phase 1/2/3, multicenter, multinational, randomized, saline placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection (Phase 1) and efficacy (Phase 2/3) study that has enrolled approximately 46,000 participants, 12 years of age or older. Of these, approximately 44,047 participants (22,026 COMIRNATY; 22,021 placebo) in Phase 2/3 are 16 years of age or older (including 378 and 376 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively) and 2260 adolescents are 12 to 15 years of age (1131 and 1129 in the vaccine and placebo groups, respectively). Study 2 also included 200 participants with confirmed stable human immunodeficiency virus (HIV) infection. HIV-positive participants are included in safety population disposition but are summarized separately in safety analyses.

Additionally, 306 existing Phase 3 participants 18 through 55 years of age received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after completing the second dose. The overall safety profile for the booster dose was similar to that seen after 2 doses.

Study C4591007 (Study 3) is a Phase 1/2/3 study comprised of an open-label vaccine dose‑finding portion (Phase 1) and a multicenter, multinational, randomized, saline placebo-controlled, observer-blind efficacy portion (Phase 2/3) that has enrolled approximately 4,600 participants 5 through less than 12 years of age. Of these, approximately 3,100 participants received COMIRNATY 10 mcg and approximately 1,500 participants received placebo in the Phase 2/3 part of the study.

The safety evaluation of participants in Study 2 and Study 3 is ongoing. In Study 2 and Study 3, all participants 5 through <12 years of age, 12 to 15 years of age and 16 years of age and older in the reactogenicity subset, and participants who received a booster dose in Study 2, were monitored for solicited local and systemic reactions and use of antipyretic medication after each vaccination with an electronic diary during the 7 days following any dose of vaccination. Participants continue to be monitored for unsolicited adverse events, including serious adverse events, throughout the study [from Dose 1 to 1 month after Dose 2 (all unsolicited adverse events) and 6 months (serious adverse events) after the last vaccination].

Participants 12 Years of Age and Older

At the time of the analysis of Study 2 (data accrued through March 13, 2021), a total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period. A total of 12,006 (54.5%) participants originally randomized to the vaccine group in Study 2 had been followed up for at least 6 months after the second dose including the blinded and open-label periods.

In an analysis of Study 2, based on data up to the cut-off date of March 13, 2021, a total of 2260 adolescents (1131 COMIRNATY; 1129 placebo) were 12 to 15 years of age. Of these, 1308 (660 COMIRNATY and 648 placebo) adolescents have been followed for at least 2 months after the second dose of COMIRNATY.

In clinical studies with a data cut-off of March 13, 2021, and where 2 doses were administered 3 weeks apart, the most common adverse reactions in the reactogenicity subset (n=4924) of participants 16 years of age and older after any dose included injection site pain (84.3%), fatigue (64.7%), headache (57.1%), muscle pain (40.2%), chills (34.7%), joint pain (25.0%), fever (15.2%), injection site swelling (11.1%), and injection site redness (9.9%). Additional adverse events reported in the safety population (n=21,926) of participants 16 years of age and older from dose 1 to 1 month after dose 2 included nausea (1.2%), malaise (0.6%), lymphadenopathy (0.4%), asthenia (0.3%), decreased appetite (0.2%), hyperhidrosis (0.1%), lethargy (0.1%), and night sweats (0.1%). Adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination.

The safety profile in 545 participants receiving COMIRNATY that were seropositive for SARS-CoV-2 at baseline was similar to that seen in the general population.

Adverse reactions after either the first or second dose in the reactogenicity subset (n=1131) of adolescents 12 to 15 years of age included injection site pain (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%), injection site redness (8.6%), lymphadenopathy (0.8%), and nausea (0.4%).

In a clinical study of participants 18 through 55 years of age (N=306), 289 participants (94%) completed the e-diary recording adverse reactions. The most commonly reported adverse reactions (≥10%) following administration of a booster dose were pain at the injection site (83.0%), fatigue (63.7%), headache (48.4%), muscle pain (39.1%), chills (29.1%), and joint pain (25.3%).

Participants 5 Through Less Than 12 Years of Age

In an analysis of Study 3 Phase 2/3, based on data up to the cut-off date of October 8, 2021, 2,268 participants (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo) were 5 through less than 12 years of age. Of these, 2,171 (95.7%) (1,456 COMIRNATY 10 mcg and 715 placebo) participants have been followed for at least 3 months after Dose 2. An analysis of Study 3 Phase 2/3 adverse event data also included another 2,379 participants (safety expansion group: 1,591 COMIRNATY 10 mcg and 788 placebo), of whom 71.2% had a follow-up period for at least 2 weeks after Dose 2. The safety evaluation in Study 3 is ongoing.

Adverse reactions following administration of any dose in the initial enrolment safety population (n = 1,518) of children 5 to less than 12 years of age included pain at the injection site (84.3%), fatigue (51.7%), headache (38.2%), injection site redness (26.4%), injection site swelling (20.4%), muscle pain (17.5%), chills (12.4%), fever (8.3%), joint pain (7.6%), lymphadenopathy (0.9%), rash (0.5%), nausea (0.4%), malaise (0.1%), and decreased appetite (0.1%).

8.2 Clinical Trial Adverse Reactions

Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials, therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug. Adverse reaction information from clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.

Participants 16 Years of Age and Older – Primary Series (Two Doses)

Solicited Adverse Reactions

Tables 3 through 6 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in the subset of participants 16 years of age and older (n=9839) in the safety population who were monitored for reactogenicity with an electronic diary.

Table 3: Study 2 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population^*)
Local Reaction	Dose 1		Dose 2
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. No Grade 4 solicited local reactions were reported in participants 16-55 years of age. b n = Number of participants with the specified reaction. c Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site. d Severe: >10.0 cm. e Severe: prevents daily activity.
Local Reaction	COMIRNATY N^a=2899 n^b (%)	Placebo N^a=2908 n^b (%)	COMIRNATY N^a=2682 n^b (%)	Placebo N^a=2684 n^b (%)
Redness
Any^c	156 (5.4)	28 (1.0)	151 (5.6)	18 (0.7)
Severe^d	7 (0.2)	3 (0.1)	11 (0.4)	0 (0.0)
Swelling
Any^c	184 (6.3)	16 (0.6)	183 (6.8)	5 (0.2)
Severe^d	6 (0.2)	2 (0.1)	7 (0.3)	0 (0.0)
Pain at the Injection Site
Any^c	2426 (83.7)	414 (14.2)	2101 (78.3)	312 (11.6)
Severe^e	39 (1.3)	3 (0.1)	39 (1.5)	0 (0.0)
Any local reaction^c	2444 (84.3)	432 (14.9)	2108 (78.6)	325 (12.1)

Table 4: Study 2 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Participants 16-55 Years of Age (Reactogenicity Subset of the Safety Population^*)
Systemic Reaction	Dose 1		Dose 2
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. No Grade 4 solicited systemic reactions were reported in participants 16-55 years of age. b n = Number of participants with the specified reaction. c Any systemic reaction: any fever ≥38.0°C, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or worsened joint pain. d Severe: prevents daily activity. e Severe: requires intravenous hydration. f Severe: 6 or more loose stools in 24 hours.
Systemic Reaction	COMIRNATY N^a=2899 n^b (%)	Placebo N^a=2908 n^b (%)	COMIRNATY N^a=2682 n^b (%)	Placebo N^a=2684 n^b (%)
Fever
≥38.0°C	119 (4.1)	25 (0.9)	440 (16.4)	11 (0.4)
>38.9°C	8 (0.3)	4 (0.1)	40 (1.5)	2 (0.1)
Fatigue
Any	1431 (49.4)	960 (33.0)	1649 (61.5)	614 (22.9)
Severe^d	41 (1.4)	18 (0.6)	142 (5.3)	14 (0.5)
Headache
Any	1262 (43.5)	975 (33.5)	1448 (54.0)	652 (24.3)
Severe^d	33 (1.1)	24 (0.8)	91 (3.4)	18 (0.7)
Chills
Any	479 (16.5)	199 (6.8)	1015 (37.8)	114 (4.2)
Severe^d	15 (0.5)	2 (0.1)	69 (2.6)	2 (0.1)
Vomiting
Any	34 (1.2)	36 (1.2)	58 (2.2)	30 (1.1)
Severe^e	0 (0.0)	1 (0.0)	4 (0.1)	0 (0.0)
Diarrhea
Any	309 (10.7)	323 (11.1)	269 (10.0)	205 (7.6)
Severe^f	3 (0.1)	1 (0.0)	6 (0.2)	1 (0.0)
New or worsened muscle pain
Any	664 (22.9)	329 (11.3)	1055 (39.3)	237 (8.8)
Severe^d	15 (0.5)	2 (0.1)	62 (2.3)	3 (0.1)
New or worsened joint pain
Any	342 (11.8)	168 (5.8)	638 (23.8)	147 (5.5)
Severe^d	5 (0.2)	1 (0.0)	27 (1.0)	4 (0.1)
Any systemic reaction^c	1979 (68.3)	1559 (53.6)	2034 (75.8)	1026 (38.2)
Use of antipyretic or pain medication	805 (27.8)	398 (13.7)	1213 (45.2)	320 (11.9)

Table 5: Study 2 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population^*)
Local Reaction	Dose 1		Dose 2
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. No Grade 4 solicited local reactions were reported in participants 56 years of age and older. b n = Number of participants with the specified reaction. c Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site. d Severe: >10.0 cm. e Severe: prevents daily activity.
Local Reaction	COMIRNATY N^a=2008 n^b (%)	Placebo N^a=1989 n^b (%)	COMIRNATY N^a=1860 n^b (%)	Placebo N^a=1833 n^b (%)
Redness
Any^c	106 (5.3)	20 (1.0)	133 (7.2)	14 (0.8)
Severe^d	5 (0.2)	2 (0.1)	10 (0.5)	1 (0.1)
Swelling
Any^c	141 (7.0)	23 (1.2)	145 (7.8)	13 (0.7)
Severe^d	2 (0.1)	0 (0.0)	4 (0.2)	1 (0.1)
Pain at the Injection Site
Any^c	1408 (70.1)	185 (9.3)	1230 (66.1)	143 (7.8)
Severe^e	4 (0.2)	0 (0.0)	10 (0.5)	0 (0.0)
Any local reaction^c	1433 (71.4)	207 (10.4)	1243 (66.8)	158 (8.6)

Table 6: Study 2 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Participants 56 Years of Age and Older (Reactogenicity Subset of the Safety Population*)
Systemic Reaction	Dose 1		Dose 2
* Randomized participants in the safety analysis population who received at least 1 dose of the study intervention. a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. The only Grade 4 solicited systemic reaction reported in participants 56 years of age and older was fatigue. b n = Number of participants with the specified reaction. c Any systemic reaction: any fever ≥38.0°C, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or worsened joint pain. d Severe: prevents daily activity. e Severe: requires intravenous hydration. f Severe: 6 or more loose stools in 24 hours. g Grade 4: emergency room visit or hospitalization.
Systemic Reaction	COMIRNATY N^a=2008 n^b (%)	Placebo N^a=1989 n^b (%)	COMIRNATY N^a=1860 n^b (%)	Placebo N^a=1833 n^b (%)
Fever
≥38.0°C	26 (1.3)	8 (0.4)	219 (11.8)	4 (0.2)
>38.9°C	1 (0.0)	2 (0.1)	7 (0.4)	1 (0.1)
Fatigue
Any	677 (33.7)	447 (22.5)	949 (51.0)	306 (16.7)
Severe^d	3 (0.1)	3 (0.2)	60 (3.2)	2 (0.1)
Grade 4^g	0 (0.0)	0 (0.0)	1 (0.1)	0 (0.0)
Headache
Any	503 (25.0)	363 (18.3)	733 (39.4)	259 (14.1)
Severe^d	2 (0.1)	3 (0.2)	13 (0.7)	5 (0.3)
Chills
Any	130 (6.5)	69 (3.5)	435 (23.4)	57 (3.1)
Severe^d	0 (0.0)	1 (0.1)	21 (1.1)	0 (0.0)
Vomiting
Any	10 (0.5)	9 (0.5)	13 (0.7)	5 (0.3)
Severe^e	0 (0.0)	0 (0.0)	2 (0.1)	0 (0.0)
Diarrhea
Any	168 (8.4)	130 (6.5)	152 (8.2)	102 (5.6)
Severe^f	4 (0.2)	1 (0.1)	2 (0.1)	4 (0.2)
New or worsened muscle pain
Any	274 (13.6)	165 (8.3)	537 (28.9)	99 (5.4)
Severe^d	1 (0.0)	3 (0.2)	20 (1.1)	1 (0.1)
New or worsened joint pain
Any	175 (8.7)	124 (6.2)	353 (19.0)	72 (3.9)
Severe^d	3 (0.1)	1 (0.1)	9 (0.5)	1 (0.1)
Any systemic reaction^c	984 (49.0)	749 (37.7)	1203 (64.7)	516 (28.2)
Use of antipyretic or pain medication	382 (19.0)	224 (11.3)	688 (37.0)	170 (9.3)

Study 2 also included 200 participants with confirmed stable human immunodeficiency virus
(HIV) infection. The safety profile of the participants with stable HIV infection receiving COMIRNATY (n = 100) was similar to that seen in the general population.

Unsolicited Adverse Events

The participants were unblinded to offer placebo participants COMIRNATY when they became locally eligible under regulatory approval in December 2020. A total of 25,651 (58.2%) participants (13,031 in vaccine group and 12,620 in placebo group) 16 years of age and older had been followed up for at least 4 months, with 3,082 (7.0%) participants (1,778 in vaccine group and 1,304 in placebo group) followed up for at least 6 months after the second dose during the blinded placebo-controlled follow-up period in Study 2. Adverse events detailed below for participants 16 years of age and older are for the placebo-controlled blinded follow-up period up to the participants’ unblinding dates.

No deaths related to the vaccine were reported in the study.

Among participants 16 through 55 years of age who received at least one dose of study vaccine, 12,995 of whom received COMIRNATY and 13,026 of whom received placebo, unsolicited adverse events were reported by 4,396 (33.8%) participants in the COMIRNATY group and 2,136 (16.4%) participants in the placebo group. In a similar analysis in participants 56 years of age and older that included 8,931 COMIRNATY recipients and 8,895 placebo recipients, unsolicited adverse events were reported by 2,551 (28.6%) participants in the COMIRNATY group and 1,432 (16.1%) participants in the placebo group. Among participants with confirmed stable HIV infection that included 100 COMIRNATY recipients and 100 placebo recipients, unsolicited adverse events were reported by 29 (29%) participants in the COMIRNATY group and 15 (15%) participants in the placebo group.

Lymphadenopathy was reported in 87 (0.4%) participants in the vaccine group compared to 8 (<0.1%) participants in the placebo group, which is plausibly related to vaccination. Bell’s palsy (facial paralysis and facial paresis) was reported by four participants in the vaccine group and two in the placebo group. In the four vaccinated participants, events began from 3 to 48 days after their last dose, were mild to moderate in severity, and duration ranged from 3 to 68 days. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of non-serious adverse events (including other neurologic or neuro-inflammatory, and thrombotic events) that would suggest a causal relationship to COMIRNATY. Cumulative safety follow-up to at least 6 months after Dose 2 for approximately 12,000 participants who received COMIRNATY showed no other safety signals arising from longer-term follow-up of the study.

Serious Adverse Events
In Study 2, among participants 16 through 55 years of age who had received at least 1 dose of vaccine or placebo (COMIRNATY =12,995; placebo = 13,026), serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 103 (0.8%) COMIRNATY recipients and 117 (0.9%) placebo recipients. In a similar analysis, in participants 56 years of age and older (COMIRNATY = 8,931; placebo = 8,895), serious adverse events were reported by 165 (1.8%) COMIRNATY recipients and 151 (1.7%) placebo recipients who received at least 1 dose of COMIRNATY or placebo, respectively. Among participants with confirmed stable HIV infection serious adverse events from Dose 1 up to the participant unblinding date in ongoing follow-up were reported by 2 (2%) COMIRNATY recipients and 2 (2%) placebo recipients.

Pericarditis was reported for one participant in the vaccine group, and no case was reported in the placebo group. Appendicitis was reported as a serious adverse event for 27 participants, 15 vaccine participants and 12 placebo participants. Currently available information is insufficient to determine a causal relationship with the vaccine. There were no other notable patterns or numerical imbalances between treatment groups for specific categories of serious adverse events (including neurologic, neuro-inflammatory, thrombotic events, myocarditis or anaphylactic reaction to the vaccine) reported during the blinded placebo-controlled follow-up period of the study.

Participants 18 to 55 Years of Age – After Booster Dose

A subset, from Study 2 Phase 2/3 participants, of 306 adults 18 through 55 years of age who completed the original COMIRNATY 2-dose series, received a booster dose of COMIRNATY approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2.

Solicited Local and Systemic Adverse Reactions

Overall, among participants who received a booster dose, the median age was 42 years (range 19 through 55 years of age), 45.8% were male and 54.2% were female, 81.4% were White, 27.8% were Hispanic/Latino, 9.2% were Black or African American, 5.2% were Asian, and 0.7% were American Indian/Alaska Native.

Table 7: Study 2 – Frequency and Percentages of Participants With Solicited Local Reactions, By Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY – Booster Dose Safety Population*
Solicited Local Reaction	COMIRNATY Booster Dose N^a= 289 n^b (%)
Redness^c
Any (>2 cm)	17 (5.9)
Severe	0
Swelling^c
Any (>2 cm)	23 (8.0)
Severe	1 (0.3)
Pain at the injection site^d
Any	240 (83.0)
Severe	1 (0.3)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after the booster dose. Note: No Grade 4 solicited local reactions were reported. * Participants in the safety analysis population who received the booster dose of COMIRNATY. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b. n = Number of participants with the specified reaction. c. Mild: >2.0 to 5.0 cm; Moderate: >5.0 to 10.0 cm; Severe: >10.0 cm. d. Mild: does not interfere with activity; Moderate: interferes with activity; Severe: prevents daily activity.

In participants who received a booster dose the mean duration of pain at the injection site after the booster dose was 2.6 days (range 1 to 8 days), for redness 2.2 days (range 1 to 15 days), and for swelling 2.2 days (range 1 to 8 days).

Table 8: Study 2 – Frequency and Percentages of Participants With Solicited Systemic Reactions, by Maximum Severity, Within 7 Days After the Booster Dose of COMIRNATY – Booster Dose Safety Population*
Solicited Systemic Reaction	COMIRNATY Booster Dose N^a= 289 n^b (%)
Fever
≥38.0℃	25 (8.7)
≥38.0℃ to 38.4℃	12 (4.2)
>38.4℃ to 38.9℃	12 (4.2)
>38.9℃ to 40.0℃	1 (0.3)
>40.0℃	0
Fatigue^c
Any	184 (63.7)
Severe	13 (4.5)
Headache^c
Any	140 (48.4)
Severe	3 (1.0)
Chills^c
Any	84 (29.1)
Severe	3 (1.0)
Vomiting^d
Any	5 (1.7)
Severe	0
Diarrhea^e
Any	25 (8.7)
Severe	0
New or worsened muscle pain^c
Any	113 (39.1)
Severe	4 (1.4)
New or worsened joint pain^c
Any	73 (25.3)
Severe	1 (0.3)
Use of antipyretic or pain medication^f	135 (46.7)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after the booster dose. Note: No Grade 4 solicited systemic reactions were reported. * Randomized participants in the safety analysis population who received the booster dose of COMIRNATY. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. b. n = Number of participants with the specified reaction. c. Mild: does not interfere with activity; Moderate: some interference with activity; Severe: prevents daily activity. d. Mild: 1 to 2 times in 24 hours; Moderate: >2 times in 24 hours; Severe: requires intravenous hydration. e. Mild: 2 to 3 loose stools in 24 hours; Moderate: 4 to 5 loose stools in 24 hours; Severe: 6 or more loose stools in 24 hours. f. Severity was not collected for use of antipyretic or pain medication.

Unsolicited Adverse Events

Overall, the 306 participants who received a booster dose had a median follow-up time of 2.6 months (range: 1.1 to 2.8 months) after the booster dose to the cut-off date (17 Jun 2021).

In an analysis of all unsolicited adverse events reported following the booster dose, through 1 month after the booster dose, in participants 18 through 55 years of age (N = 289), those assessed as adverse reactions not already captured by solicited local and systemic reactions were lymphadenopathy (16, 5.2%), nausea (2, 0.7%), decreased appetite (1, 0.3%), rash (1, 0.3%), and pain in extremity (1, 0.3%).

Serious Adverse Events

Of the 306 participants who received a booster dose of COMIRNATY, there were no serious adverse events reported from the booster dose through 30 days after the booster dose.

Adolescents 12 to 15 Years of Age– Primary Series (Two Doses)

Solicited Adverse Reactions

Table 9 and Table 10 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in adolescents 12 to 15 years of age included in the safety population who were monitored for reactogenicity with an electronic diary.

Table 9: Study 2 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Adolescents 12 to 15 Years of Age – Safety Population*
Local Reaction	COMIRNATY Dose 1 N^a=1127 n^b (%)	Placebo Dose 1 N^a=1127 n^b (%)	COMIRNATY Dose 2 N^a=1097 n^b (%)	Placebo Dose 2 N^a=1078 n^b (%)
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. a N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b n = Number of participants with the specified reaction. c Severe: >10.0 cm. d Severe: prevents daily activity. e Any local reaction: any redness >2.0 cm, any swelling >2.0 cm, or any pain at the injection site. * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Redness
Any (>2 cm)	65 (5.8)	12 (1.1)	55 (5.0)	10 (0.9)
Severe^c	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Swelling
Any (>2 cm)	78 (6.9)	11 (1.0)	54 (4.9)	6 (0.6)
Severe^c	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Pain at the injection site
Any	971 (86.2)	263 (23.3)	866 (78.9)	193 (17.9)
Severe^d	11 (1.0)	0 (0.0)	7 (0.6)	0 (0.0)
Any local reaction^e	976 (86.6)	271 (24.0)	872 (79.5)	198 (18.4)

Table 10: Study 2 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Adolescents 12 to 15 Years of Age – Safety Population*
Systemic Reaction	COMIRNATY Dose 1 N^a=1127 n^b (%)	Placebo Dose 1 N^a=1127 n^b (%)	COMIRNATY Dose 2 N^a=1097 n^b (%)	Placebo Dose 2 N^a=1078 n^b (%)
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. a N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. b n = Number of participants with the specified reaction. c Severe: prevents daily activity. d Severe: requires intravenous hydration. e Severe: 6 or more loose stools in 24 hours. f Any systemic reaction: any fever ≥38.0°C, any fatigue, any vomiting, any chills, any diarrhea, any headache, any new or worsened muscle pain, or any new or worsened joint pain * Randomized participants in the safety analysis population who received at least 1 dose of the study intervention.
Fever
≥38.0°C	114 (10.1)	12 (1.1)	215 (19.6)	7 (0.6)
>38.9°C	11 (1.0)	2 (0.2)	25 (2.3)	1 (0.1)
Fatigue
Any	677 (60.1)	457 (40.6)	726 (66.2)	264 (24.5)
Severe^c	15 (1.3)	8 (0.7)	26 (2.4)	4 (0.4)
Headache
Any	623 (55.3)	396 (35.1)	708 (64.5)	263 (24.4)
Severe^c	11 (1.0)	9 (0.8)	22 (2.0)	1 (0.1)
Chills
Any	311 (27.6)	109 (9.7)	455 (41.5)	73 (6.8)
Severe^c	5 (0.4)	2 (0.2)	20 (1.8)	0 (0.0)
Vomiting
Any	31 (2.8)	10 (0.9)	29 (2.6)	12 (1.1)
Severe^d	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Diarrhea
Any	90 (8.0)	82 (7.3)	65 (5.9)	43 (4.0)
Severe^e	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
New or worsened muscle pain
Any	272 (24.1)	148 (13.1)	355 (32.4)	90 (8.3)
Severe^c	2 (0.2)	0 (0.0)	6 (0.5)	2 (0.2)
New or worsened joint pain
Any	109 (9.7)	77 (6.8)	173 (15.8)	51 (4.7)
Severe^c	1 (0.1)	0 (0.0)	4 (0.4)	0 (0.0)
Any systemic reactions^f	877 (77.8)	636 (56.4)	904 (82.4)	439 (40.7)
Use of antipyretic or pain medication	413 (36.6)	111 (9.8)	557 (50.8)	95 (8.8)

Unsolicited Adverse Events

In the analysis of Study 2 among adolescents 12 to 15 years of age, 98.3% of study participants had at least 30 days of follow-up after Dose 2 (1131 adolescents received COMIRNATY and 1129 adolescents received placebo).

Unsolicited adverse events (both serious and non-serious) were reported by 6.4% of COMIRNATY recipients and by 6.3% of placebo recipients. Lymphadenopathy was reported in 9 participants (0.8%) in the vaccine group compared to 2 participants (0.2%) in the placebo group. Serious adverse events were reported by 0.4% of COMIRNATY recipients and by 0.2% of placebo recipients.

Children 5 Through Less Than 12 Years of Age – Primary Series (Two Doses)

Solicited Adverse Reactions

Table 11 and Table 12 present the frequency and severity of solicited local and systemic reactions, respectively, within 7 days following each dose of COMIRNATY and placebo in children 5 through less than 12 years of age included in the initial enrolment safety population who were monitored for reactogenicity with an electronic diary.

Table 11: Study 3 – Frequency of Solicited Local Reactions Within 7 Days After Each Dose – Children 5 Through Less Than 12 Years of Age – Safety Population*
Note: Reactions were collected in the electronic diary (e-diary) from Day 1 to Day 7 after vaccination. a. N = Number of participants reporting at least 1 yes or no response for the specified reaction after the specified dose. b. The denominators (N) used in the percentage calculations for redness and swelling were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. c. n = Number of participants with the specified reaction. d. Severe: >7.0 cm. e. Severe: prevents daily activity. * Randomized participants who received at least 1 dose of the study intervention.
	COMIRNATY Dose 1 N^a=1511 n^c (%)	Placebo Dose 1 N^a,b=748 n^c (%)	COMIRNATY Dose 2 N^a=1501 n^c (%)	Placebo Dose 2 N^a,b=740 n^c (%)
Redness^d
Any (≥0.5 cm)	222 (14.7)	43 (5.7)	278 (18.5)	40 (5.4)
Severe	0 (0.0)	0 (0.0)	3 (0.2)	0 (0.0)
Swelling^d
Any (≥0.5 cm)	158 (10.5)	20 (2.7)	229 (15.3)	20 (2.7)
Severe	1 (0.1)	0 (0.0)	0 (0.0)	0 (0.0)
Pain at the injection site^e
Any	1119 (74.1)	234 (31.3)	1065 (71.0)	218 (29.5)
Severe	4 (0.3)	0 (0.0)	5 (0.3)	0 (0.0)

Table 12: Study 3 – Frequency of Solicited Systemic Reactions Within 7 Days After Each Dose – Children 5 Through Less Than 12 Years of Age – Safety Population*
Note: Events and use of antipyretic or pain medication were collected in the electronic diary (e-diary) from Day 1 to Day 7 after each dose. a. N = Number of participants reporting at least 1 yes or no response for the specified event after the specified dose. b. The denominators (N) used in the percentage calculations for fever and use of antipyretic or pain medication were 749 after Dose 1 and 741 after Dose 2 in the placebo group, due to an e-diary error. c. n = Number of participants with the specified reaction. d. Severe: prevents daily activity. e. Severe: requires intravenous hydration. f. Severe: 6 or more loose stools in 24 hours. g. Severity was not collected for use of antipyretic or pain medication. * Randomized participants who received at least 1 dose of the study intervention.
	COMIRNATY Dose 1 N^a=1511 n^c (%)	Placebo Dose 1 N^a,b=748 n^c (%)	COMIRNATY Dose 2 N^a=1501 n^c (%)	Placebo Dose 2 N^a,b=740 n^c (%)
Fever
≥38.0℃	38 (2.5)	10 (1.3)	98 (6.5)	9 (1.2)
>38.9℃	3 (0.2)	1 (0.1)	9 (0.6)	1 (0.1)
Fatigue^d
Any	508 (33.6)	234 (31.3)	592 (39.4)	180 (24.3)
Severe	4 (0.3)	1 (0.1)	11 (0.7)	1 (0.1)
Headache^d
Any	339 (22.4)	180 (24.1)	420 (28.0)	138 (18.6)
Severe	2 (0.1)	4 (0.5)	3 (0.2)	0 (0.0)
Chills^d
Any	70 (4.6)	35 (4.7)	147 (9.8)	32 (4.3)
Severe	0 (0.0)	0 (0.0)	2 (0.1)	1 (0.1)
Vomiting^e
Any	33 (2.2)	11 (1.5)	28 (1.9)	6 (0.8)
Severe	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Diarrhea^f
Any	89 (5.9)	31 (4.1)	79 (5.3)	35 (4.7)
Severe	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
New or worsened muscle pain^d
Any	137 (9.1)	51 (6.8)	175 (11.7)	55 (7.4)
Severe	1 (0.1)	0 (0.0)	1 (0.1)	0 (0.0)
New or worsened joint pain^d
Any	50 (3.3)	41 (5.5)	78 (5.2)	27 (3.6)
Severe	0 (0.0)	0 (0.0)	0 (0.0)	0 (0.0)
Use of antipyretic or pain medication^g	217 (14.4)	62 (8.3)	296 (19.7)	60 (8.1)

Unsolicited Adverse Events

In the analyses of Study 3 in children 5 through less than 12 years of age (initial enrolment group: 1,518 COMIRNATY 10 mcg and 750 placebo), 99.5% of participants had at least 30 days and 95.7% of participants had at least 3 months follow-up after Dose 2.

Serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow‑up in the initial enrolment group were reported by 1 participant (0.1%) in each group after receiving the vaccine or placebo through the data cut-off date. No serious adverse events were reported that were considered related to vaccination.

Non-serious adverse events from Dose 1 through up to 30 days after Dose 2 in ongoing follow‑up in the initial enrolment group were reported by 10.9% of COMIRNATY 10 mcg recipients and by 9.1% of placebo recipients. Lymphadenopathy was reported in 13 (0.9%) participants in the COMIRNATY 10 mcg group vs. 1 (0.1%) in the placebo group. All cases were considered to be mild, with a median onset of 3 days after Dose 1, and 2 days after Dose 2 in the vaccine group. The median duration was 3.5 days (ranged from 1 to 14 days) in the vaccine group. Skin and subcutaneous tissue disorders (including skin rash, dermatitis, eczema and urticaria) were reported in 17 (1.1%) participants in the vaccine group and 5 (0.7%) participants in the placebo group. Most of the events began from 3-11 days after the second dose and were characterized as mild and self-limited. There were no other notable patterns between treatment groups for specific categories of non-serious adverse events that would suggest a causal relationship to COMIRNATY. There were no reports of myocarditis/pericarditis or anaphylaxis by the study cut-off date.

8.3 Post-Market Adverse Reactions

The following adverse reactions have been identified during post authorization use of COMIRNATY.

Cardiac disorders: myocarditis and/or pericarditis (see WARNING AND PRECAUTIONS section)

Immune System Disorders: severe allergic reactions, including anaphylaxis

Musculoskeletal and Connective Tissue Disorders: pain in extremity (arm)

Nervous System Disorders: Facial paralysis / Bell’s Palsy, hypoesthesia, paresthesia

Skin and subcutaneous tissue disorders and other hypersensitivity reactions: skin rash, pruritus, urticaria, angioedema, erythema multiforme

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to product exposure. They are included because: a) they represent reactions that are known to occur following immunizations generally; b) they are potentially serious; or c) on the basis of their frequency of reporting.

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9 Drug Interactions

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10 Clinical Pharmacology

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11 Storage, Stability And Disposal

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During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.

Do not refreeze thawed vials.

For 12 Years and Older: DILUTE BEFORE USE (Vials with Purple Cap and Purple Label Border)

Frozen Vials Prior to Use
Cartons of COMIRNATY multiple dose vials (for 12 years and older: DILUTE BEFORE USE) arrive in thermal containers with dry ice. To ensure all appropriate safeguards are in place, refer to the Dry Ice Safety Data Sheet and the COMIRNATY Shipping and Handling Guidelines available at COMIRNATY.ca. Once received, remove the vial cartons immediately from the thermal container and preferably store in an ultra-low temperature freezer between ‑90°C to -60°C (-130°F to -76°F) until the expiry date printed on the label. Vials may also be stored at -25°C to -15°C (‑13°F to 5°F) for up to 2 weeks. Vials must be kept frozen and protected from light, in the original cartons, until ready to use. Vials stored at -25°C to ‑15°C (-13°F to 5°F) for up to 2 weeks may be returned one time to the recommended storage condition of -90°C to -60°C (-130°F to -76°F). Total cumulative time the vials are stored at -25°C to -15°C (-13°F to 5°F) should be tracked and should not exceed 2 weeks.

If an ultra-low temperature freezer is not available, the thermal container in which COMIRNATY arrives may be used as temporary storage when consistently re-filled to the top of the container with dry ice. Refer to the re-icing guidelines packed in the original thermal container for instructions regarding the use of the thermal container for temporary storage. The thermal container maintains a temperature range of -90°C to -60°C (‑130°F to -76°F). Storage of the vials between -96°C to -60°C (-141°F to -76°F) is not considered an excursion from the recommended storage condition.

Transportation of Frozen Vials
If local redistribution is needed and full cartons containing vials cannot be transported at ‑90°C to ‑60°C (‑130°F to ‑76°F), vials may be transported at -25°C to ‑15°C (-13°F to 5°F). Any hours used for transport at -25°C to -15°C (-13°F to 5°F) count against the 2‑week limit for storage at -25°C to -15°C (-13°F to 5°F). Frozen vials transported at -25°C to -15°C (‑13°F to 5°F) may be returned one time to the recommended storage condition of -90°C to -60°C (-130°F to -76°F).

Thawed Vials Prior to Dilution

Thawed Under Refrigeration: Thaw and then store undiluted vials in the refrigerator (2°C to 8°C [35°F to 46°F]) for up to 1 month. A carton of 25 vials or 195 vials may take up to 2 or 3 hours, respectively, to thaw in the refrigerator, whereas a fewer number of vials will thaw in less time.

Thawed at Room Temperature: For immediate use, thaw undiluted vials at room temperature (up to 25°C (77°F)] for 30 minutes.

Thawed vials can be handled in room light conditions.

Vials must reach room temperature before dilution.

Undiluted vials may be stored at room temperature for no more than 2 hours.

Transportation of Thawed Vials
Available data support transportation of one or more thawed, undiluted vials at 2°C to 8°C (35°F to 46°F) for up to 12 hours. Any hours used for transport at 2°C to 8°C (35°F to 46°F) count against the 1-month limit for storage at 2°C to 8°C (35°F to 46°F).

Vials After Dilution
After dilution, store vials between 2°C to 25°C (35°F to 77°F) and use within 6 hours from the time of dilution. Any vaccine remaining in vials must be discarded after 6 hours. After dilution, the vaccine vials can be handled in room light conditions. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Do not freeze. If the vaccine is frozen, it must be discarded.

For 12 Years and Older: DO NOT DILUTE (Vials with Gray Cap and Gray Label Border)

Vial Storage Prior to Use

Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may arrive frozen at ultra cold conditions in thermal containers with dry ice.

Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for a single period of up to 10 weeks within the 12-month shelf-life. The 10 week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 vials may take up to 6 hours to thaw at this temperature.

Alternatively, frozen vials may be stored in an ultra-low temperature freezer at 90°C to 60°C ( 130°F to 76°F). Do not store vials at 25°C to 15°C (-13°F to 5°F). Once vials are thawed they should not be refrozen.

Cartons of COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may also arrive at 2°C to 8°C. If received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

Regardless of storage condition, vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons.

Vial Storage During Use

If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.

COMIRNATY multiple dose vials (for 12 years and older: DO NOT DILUTE) may be stored at room temperature up to 25°C (77°F) for a total of 12 hours prior to the first puncture.

DO NOT DILUTE PRIOR TO USE.

After first puncture, the vial should be stored at 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after first puncture. Vial labels and cartons may state that a vial should be discarded 6 hours after the first puncture. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons.

Thawed vials can be handled in room light conditions.

Transportation of Vials

If local redistribution is needed, full cartons containing unpunctured vials may be transported at -90°C to -60°C (-130°F to -76°F); full cartons or individual unpunctured vials may also be transported at 2°C to 8°C (35°F to 46°F).

For Age 5 Years to <12 Years: DILUTE PRIOR TO USE (Vials with Orange Cap and Orange Label Border)

Vial Storage Prior to Use

Cartons of COMIRNATY (for age 5 years to <12 years) may arrive frozen at ultra-cold conditions in thermal containers with dry ice.

Cartons of COMIRNATY (for age 5 years to <12 years) may also arrive at 2°C to 8°C (35°F to 46°F). If vials are received at 2°C to 8°C, they should be stored at 2°C to 8°C. Check that the carton has been updated to reflect the 10-week refrigerated expiry date.

Regardless of storage condition, vaccines should not be used after 12 months from the date of manufacture printed on the vial and cartons.

Vial Storage During Use

If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.

Vials of COMIRNATY (for age 5 years to <12 years) may be stored at temperatures up to 25°C (77°F) for a total of 12 hours prior to dilution.

After dilution the vials should be stored at 2°C to 25°C (35°F to 77°F). Vials should be discarded 12 hours after dilution (i.e., the first puncture). Vial labels and cartons may state that a vial should be discarded 6 hours after dilution. The information in this Product Monograph supersedes the number of hours printed on vial labels and cartons.

Thawed vials can be handled in room light conditions.

Transportation of Vials

If local redistribution is needed, full cartons containing undiluted vials may be transported at ‑90°C to ‑60°C (‑130°F to ‑76°F); full cartons or individual undiluted vials may also be transported at 2°C to 8°C (35°F to 46°F).

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12 Special Handling Instructions

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Comirnaty (COVID-19 Vaccine, mRNA) Quick Finder

1 Health Professional Information

1 INDICATIONS

1.1 Pediatrics

1.2 Geriatrics

2 Contraindications

3 Serious Warnings And Precautions

4 Dosage And Administration

4.1 Dosing Considerations

4.2 Recommended Dose and Dosage Adjustment

4.3 Reconstitution

4.4 Administration

5 Overdosage

6 Dosage Forms, Strengths, Composition And Packaging

7 Warnings And Precautions

General

Acute Allergic Reactions

Cardiovascular

Driving and Operating Machinery

Fertility

Hematologic

Immune

7.1 Special Populations

7.1.1 Pregnant Women

7.1.2 Breast-feeding

7.1.3 Pediatrics

7.1.4 Geriatrics

8 Adverse Reactions

8.1 Adverse Reaction Overview

8.2 Clinical Trial Adverse Reactions

8.3 Post-Market Adverse Reactions

9 Drug Interactions

10 Clinical Pharmacology

10.1 Mechanism of Action

11 Storage, Stability And Disposal

12 Special Handling Instructions