COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (MDV)

4.1 Therapeutic indications

COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 5 to <12 years of age.

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

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.

4.2 Posology and method of administration

Posology

Booster dose in individuals 5 through <12 years of age

A booster dose of COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) may be administered intramuscularly in individuals 5 years through <12 years of age who have previously received at least a primary vaccination course against COVID-19.

COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) cannot be used in individuals 12 years of age and older.

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 5 years has not yet been established.

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.

After dilution, vials of COMIRNATY (Bivalent) (For Age 5 Years to <12 Years) (Vials with Orange Cap) 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. 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 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.

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, dilution, 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.