COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE [SIN17053P]

Product Info

COMIRNATY ORIGINAL/OMICRON BA.4-5 CONCENTRATE FOR DISPERSION FOR INJECTION 1.5/1.5 MICROGRAMS/DOSE

[SIN17053P]

4.1 Therapeutic indications

COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months to <5 years of age.

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

4.2 Posology and method of administration

Posology

Individuals 6 months through <5 years of age

COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) is administered intramuscularly after dilution as a primary series of 3 doses (0.2 mL). The initial 2 doses are administered 3 weeks apart followed by a third dose administered at least 8 weeks after the second dose.

Individuals who will turn from 4 years 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 individual’s age at the start of the vaccination series.

Booster dose in individuals 6 months through <5 years of age

A booster dose of COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) should be administered intramuscularly at least 3 months after the last prior dose in individuals 6 months through <5 years of age.

COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon Cap) cannot be used in individuals 5 years of age and older.

Interchangeability

The interchangeability of COMIRNATY (Bivalent) with other COVID-19 vaccines to complete the primary vaccination series has not been established. Individuals who have received 1 dose of COMIRNATY or COMIRNATY (Bivalent) should receive a second and third dose of COMIRNATY or COMIRNATY (Bivalent) to complete the primary vaccination series.

Individuals may not be protected until at least 7 days after their primary series of 3 doses of the vaccine.

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 paediatric participants aged less than 6 months have not yet been established.

Method of administration

In individuals 6 to less than 12 months of age, administer COMIRNATY (Bivalent) intramuscularly in the anterolateral aspect of the thigh. In individuals 1 years of age and older, administer COMIRNATY (Bivalent) intramuscularly in the anterolateral aspect of the thigh or the deltoid muscle.

Do not inject the vaccine intravascularly, subcutaneously or intradermally.

After dilution, vials of COMIRNATY (Bivalent) (For Age 6 Months to <5 Years) (Vials with Maroon 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.

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.