COMIRNATY ORIGINAL/OMICRON BA.4-5 DISPERSION FOR INJECTION 5/5 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) [SIN17058P]

Product Info

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

[SIN17058P]

4.1 Therapeutic indications

COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue 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.

4.2 Posology and method of administration

Posology

Individuals 5 through <12 years of age

COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) is administered intramuscularly as a primary series of 2 doses (0.3 mL) at greater than or equal to 21 days (preferably 3 weeks) apart.

If the primary series starts with COMIRNATY (For Age 5 Years to <12 Years) (Vials with Orange Cap), the series may be completed with COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap).

Booster dose in individuals 5 through <12 years of age

A booster dose of COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) should be administered intramuscularly at least 3 months after the last prior dose in individuals 5 years through <12 years of age.

COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) should be used only for children 5 to <12 years of age.

Interchangeability

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

Individuals may not be protected until at least 7 days after their second dose 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 children aged less than 6 months 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.

Single dose vials of COMIRNATY (Bivalent) (Do Not Dilute) (For Age 5 Years to <12 Years) (Vials with Blue Cap) contain 1 dose of 0.3 mL of vaccine.

• Withdraw a single 0.3 mL dose of COMIRNATY (Bivalent)

• Discard 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.