COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL) [SIN17017P]

Product Info

COMIRNATY, DISPERSION FOR INJECTION, 10 MICROGRAMS/DOSE (SINGLE-DOSE VIAL)

[SIN17017P]

4.1 Therapeutic indications

COMIRNATY is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 6 months of age and older.

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

4.2 Posology and method of administration

Posology

A booster may be administered at least 3 months after completion of primary series and in accordance with official recommendations.

Individuals who have partially completed the primary series with a COVID-19 vaccine

Individuals 6 months through <12 years of age who have partially completed the primary series should complete the primary series with an age-appropriate dose of the most current COMIRNATY presentation available. Refer to Table 3 for the age-appropriate primary series dosing.

Individuals 12 years of age and older who have partially completed the primary series should receive a single dose of the most current COMIRNATY presentation available.

Individuals who have previously completed a primary series with a COVID-19 vaccine

Individuals 6 months of age and older who have previously completed a primary series should receive a single dose with the most current COMIRNATY presentation at least 3 months after the previous dose.

Individuals may not be protected until 7 days after they have completed their dosing recommendations as noted in Table 3 (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Additional booster doses in individuals 12 years of age and older

Any subsequent doses of COMIRNATY may be administered at least 3 months after a previous dose of COMIRNATY and in accordance with official recommendations.

Interchangeability with other COVID-19 vaccines

The interchangeability of COMIRNATY with other COVID-19 vaccines has not been established.

Paediatric population

The safety and efficacy of COMIRNATY in paediatric participants aged less than 6 months have not yet been established. Limited data are available.

Elderly population

No dosage adjustment is required in elderly individuals ≥65 years of age. The safety of a booster dose of COMIRNATY in individuals 65 years of age and older is based on safety data in 12 booster dose recipients 65 through 85 years of age in Study 2, 306 booster dose recipients 18 through 55 years of age in Study 2, and 1,175 booster dose recipients 65 years of age and older in Study 4. The effectiveness of a booster dose of COMIRNATY in individuals 65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through 55 years of age in Study 2, and an efficacy analysis from participants 16 years of age and older in 9,945 participants in Study 4.

Method of administration

Administer COMIRNATY intramuscularly. Do not administer intravascularly, subcutaneously, or intradermally.

• In individuals 6 months to <12 months of age: administer COMIRNATY in the anterolateral aspect of the thigh.

• In individuals 1 year to <5 years of age: administer COMIRNATY in the anterolateral aspect of the thigh or the deltoid muscle.

• In individuals 5 years of age and older: administer COMIRNATY in the deltoid muscle.

For detailed instructions on the handling, dilution, and dose preparation of the vaccine before administration, 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.