COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) [SIN16856P]

Product Info

COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 15/15 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)

[SIN16856P]

4.1 Therapeutic indications

COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.

The use of this vaccine should be in accordance with official recommendations.

4.2 Posology and method of administration

Posology

Booster dose in individuals 12 years of age and older

A booster dose of COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap) may be administered intramuscularly after completing the primary series of COMIRNATY or after a previous booster dose of COMIRNATY or COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap).

For further information on efficacy, see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Paediatric population
The safety and efficacy of COMIRNATY (Bivalent) in children aged less than 12 years has not yet been established.

Elderly population
No dosage adjustment is required in elderly individuals ≥65 years of age. The safety of a booster dose of COMIRNATY in individuals 65 years of age and older is based on safety data in 12 booster dose recipients 65 through 85 years of age in Study 2, 306 booster dose recipients 18 through 55 years of age in Study 2, and 1,175 booster dose recipients 65 years of age and older in Study 4. The safety of COMIRNATY (Bivalent) as a second booster in individuals 65 years of age and older is based on safety data in 159 booster dose recipients 65 years of age and older and 35 booster dose recipients 75 years of age and older in C4591044 (Study 5). The effectiveness of a booster dose of COMIRNATY in individuals 65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through 55 years of age in Study 2, and an efficacy analysis from participants 16 years of age and older in 9,945 participants in Study 4.

Method of administration

COMIRNATY (Bivalent) should be administered intramuscularly (see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The preferred site is the deltoid muscle of the upper arm.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

Single dose vials
Single dose vials of COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap) contain 1 dose of 0.3 mL of vaccine.

• Withdraw a single 0.3 mL dose of COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap).

• Discard vial and any excess volume.

• Do not pool excess vaccine from multiple vials.

Multidose vials
Multidose vials of COMIRNATY (Bivalent) (For 12 Years of Age and Older) (Vials with Grey Cap) contain 6 doses of 0.3 mL of vaccine.

Low dead-volume syringes and/or needles can be used to extract 6 doses from a single vial. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose 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.

The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.

For precautions to be taken before administering the vaccine, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

For instructions regarding thawing, handling, dose preparation of vaccine before administration, and disposal of the vaccine, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.