Spikevax dispersion for injection 50mcg/0.5ml in single-dose vial

4.1 Therapeutic indications

Spikevax XBB.1.5 is indicated for active immunisation to prevent COVID-19 disease caused by SARS- CoV-2 in individuals 12 years of age and older (see sections 4.2 and 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

Paediatric population
The safety and efficacy of Spikevax XBB.1.5 in children less than 6 months of age have not yet been established. No data are available.

Elderly population
No dosage adjustment is required in elderly individuals ≥65 years of age.

Method of administration

The vaccine should be administered intramuscularly. The preferred site is the deltoid muscle of the upper arm.

Do not administer this vaccine intravascularly, subcutaneously or intradermally.

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 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.