PFIZER-BIONTECH COVID-19 VACCINE BNT162b2 Suspension for injection Ref.[10429] Active ingredients: Tozinameran

For intramuscular injection only.

2.1 Preparation for Administration

Prior to Dilution:

• The Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vial contains a frozen suspension that does not contain preservative and must be thawed and diluted prior to administration.
• Vials may be thawed in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] or at room temperature [up to 25ºC (77ºF)] [see How Supplied/Storage and Handling (19)].
• Refer to thawing instructions in the panels below.

Dilution:

• Dilute the vial contents using 1.8 mL of 0.9% Sodium Chloride Injection, USP (not provided) to form the Pfizer-BioNTech COVID-19 Vaccine.
• 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.
• Refer to dilution and dose preparation instructions in the panels below.

THAWING PRIOR TO DILUTION:

• Thaw vial(s) of Pfizer-BioNTech COVID-19 Vaccine before use either by:•• Allowing vial(s) to thaw in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)]. A carton of vials may take up to 3 hours to thaw, and thawed vials can be stored in the refrigerator for up to five days (120 hours). •• Allowing vial(s) to sit at room temperature [up to 25ºC (77ºF)] for 30 minutes. • Using either thawing method, vials must reach room temperature before dilution and must be diluted within 2 hours.

• 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 discolored 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 1.8 mL of diluent into a transfer syringe (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 the Pfizer-BioNTech COVID-19 Vaccine 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 discolored or contains particulate matter.
	• Record the date and time of dilution on the Pfizer-BioNTech COVID-19 Vaccine vial label. • Store between 2°C to 25°C (35°F to 77°F). • Discard any unused vaccine 6 hours after dilution.

PREPARATION OF INDIVIDUAL 0.3 mL DOSES OF PFIZER-BIONTECH COVID-19 VACCINE:

• Using aseptic technique, cleanse the vial stopper with a single-use antiseptic swab, and withdraw 0.3 mL of the Pfizer-BioNTech COVID-19 Vaccine. • Administer immediately.

2.2 Administration Information

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 discoloration is observed.
• do not administer if vaccine is discolored or contains particulate matter.

Administer the Pfizer-BioNTech COVID-19 Vaccine intramuscularly.

2.3 Vaccination Schedule for Individuals 16 Years of Age and Older

The Pfizer-BioNTech COVID-19 Vaccine is administered intramuscularly as a series of two doses (0.3 mL each) three weeks apart.

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

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

Do not refreeze thawed vials.

Frozen Vials Prior to Use

Cartons of Pfizer-BioNTech COVID-19 Vaccine Multiple Dose Vials arrive in thermal containers with dry ice. Once received, remove the vial cartons immediately from the thermal container and store in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). Vials must be kept frozen between -80ºC to -60ºC (-112ºF to -76ºF) and protected from light, in the original cartons, until ready to use.

If an ultra-low temperature freezer is not available, the thermal container in which the Pfizer-BioNTech COVID-19 Vaccine 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 -90ºC to -60ºC (-130ºF to -76ºF). Storage within this temperature range is not considered an excursion from the recommended storage condition.

Thawed Vials Before Dilution

Thawed Under Refrigeration:

Thaw and then store undiluted vials in the refrigerator [2ºC to 8ºC (35ºF to 46ºF)] for up to 5 days (120 hours). 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 25ºC (77ºF)] 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.

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. During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light. Any vaccine remaining in vials must be discarded after 6 hours. Do not refreeze.