Comirnaty (COVID-19 Vaccine, mRNA) and Comirnaty Original & Omicron BA.4/BA.5 [bivalent] 4 Dosage And Administration

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.

For Age 6 Months to <5 Years

COMIRNATY is a suspension for intramuscular injection which must be diluted prior to administration.

DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon 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 sterile 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 sterile 0.9% Sodium Chloride Injection, USP prior to use	10	0.2 mL
COMIRNATY* Multiple Dose Vial (for age 6 months to <5 years: DILUTE PRIOR TO USE)	Maroon	6 months to <5 years	Dilute with 2.2 mL sterile 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 16 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 6 months to <12 years.

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

COMIRNATY is administered intramuscularly as a primary series of two doses (0.2 mL each) 3 weeks apart.
A booster dose of COMIRNATY (0.2 mL) may be administered intramuscularly at least 6 months after completion of the primary series in individuals 5 years through ˂12 years of age.

There are no data available on the interchangeability of COMIRNATY with other COVID-19 vaccines to complete the primary vaccination series or for a booster dose. Individuals who have received one dose of COMIRNATY should receive a second dose of COMIRNATY to complete the primary vaccination series and for any additional doses.

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 6 months to <5 years or 12 years of age and older.

4.2.3 Vaccination Schedule for Individuals Aged 6 Months to <5 Years

COMIRNATY is administered intramuscularly as a primary series of three doses (0.2 mL each). The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.

Children who will turn from 4 to 5 years of age between their doses in the vaccination series should receive their age-appropriate dose at the time of the vaccination and the interval between doses is determined by the child’s age at the start of the vaccination series.

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 continue to receive COMIRNATY to complete the vaccination series.

Vials of COMIRNATY intended for individuals aged 6 months to <5 years (maroon cap/maroon label border) cannot be used to prepare doses for individuals 5 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 or a maroon plastic cap and maroon 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 or a maroon plastic cap and maroon 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 18 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 of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 6 months to <5 years with a maroon cap/maroon 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 maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic 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 18 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 maroon plastic cap and maroon label border, purple plastic cap/purple label border or gray plastic 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 18 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.

4.3.3 For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border)

Preparation for Administration

Prior to Dilution:

The COMIRNATY multiple dose vial (for age 6 months to <5 years) has a maroon cap and a maroon label border and contains a volume of 0.4 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 individuals 12 years of age or older with a purple cap/purple label border or gray cap/gray label border and vials of COMIRNATY intended for individuals aged 5 years to <12 years with an orange cap/orange label border cannot be used to prepare doses for individuals aged 6 months to <5 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 2.2 mL of sterile 0.9% Sodium Chloride Injection, USP to form COMIRNATY. Do not add more than 2.2 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.

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.

*: 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 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border) VIAL AND DOSE VERIFICATION
	Verify that the vial has a maroon plastic cap and a maroon label border. Do not use COMIRNATY vials with an orange plastic cap/orange label border, purple plastic cap/purple label border or gray plastic cap/gray label border to prepare doses for individuals aged 6 months to <5 years. The date printed on the vial and carton reflects the date of manufacture. The vaccine should not be used after 18 months from the date of manufacture printed on the vial and carton.
For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon 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 10 vials may take up to 2 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.
For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border) DILUTION
	Obtain sterile 0.9% Sodium Chloride Injection, USP. Use only this as the diluent. Using aseptic technique, withdraw 2.2 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 2.2 mL of 0.9% Sodium Chloride Injection, USP into the vaccine vial.
	Equalize vial pressure before removing the needle from the vial by withdrawing 2.2 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 6 months to <5 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.

For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border) PREPARATION OF INDIVIDUAL 0.2 mL DOSES
	Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 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.

For Age 6 Months to <5 Years: DILUTE PRIOR TO USE (Vials with Maroon Cap and Maroon Label Border)

PREPARATION OF INDIVIDUAL 0.2 mL DOSES

Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.2 mL of COMIRNATY (for age 6 months to <5 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.

4.4.3 For Age 6 Months to <5 Years

Administer a single 0.2 mL dose of COMIRNATY intramuscularly. In individuals from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 year of age and older, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

DILUTE PRIOR TO USE (Vial with Maroon Cap and Maroon 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 6 months to <5 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.