NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 MCG/DOSE (RECOMBINANT, ADJUVANTED) IN SDV [SIN17148P]

Product Info

NUVAXOVID DISPERSION FOR INJECTION COVID-19 VACCINE 5 MCG/DOSE (RECOMBINANT, ADJUVANTED) IN SDV

[SIN17148P]

4.1 Therapeutic indications

Nuvaxovid JN.1 is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 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

Primary vaccination series
Individuals 12 years of age and older
Nuvaxovid JN.1 is administered intramuscularly as a course of 2 doses of 0.5 mL each. It is recommended to administer the second dose 3 weeks after the first dose, see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Interchangeability
There are no data available on the interchangeability of Nuvaxovid JN.1 with other COVID-19 vaccines to complete the primary vaccination course. Individuals who have received a first dose of Nuvaxovid JN.1 should receive the second dose of Nuvaxovid JN.1 to complete the vaccination course.

Booster dose
Booster dose in individuals 12 years of age and older
A booster dose of Nuvaxovid (0.5 mL) may be administered intramuscularly after the primary series of Nuvaxovid JN.1 in individuals 12 years of age and older. The decision when and for whom to implement a booster dose of Nuvaxovid JN.1 should be made based on available vaccine safety and effectiveness data, in accordance with official recommendations.

For individuals who have previously been vaccinated with a COVID-19 vaccine, Nuvaxovid JN.1 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.

Immunocompromised individuals
Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations, see section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Paediatric population
The safety and efficacy of Nuvaxovid JN.1 in children aged less than 12 years have not yet been established. No data are available.

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

Method of administration

Nuvaxovid JN.1 is for intramuscular injection only, preferably into the deltoid muscle of the upper arm.

Do not inject the 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 on 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.

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.