Medicinal Product

Form and presentation of product administered

Route of administration

Indication for which the medicinal product may be administered

Dosage and conditions of administration

Place of administration

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Nuvaxovid dispersion for injection

COVID-19 Vaccine (recombinant, adjuvanted)

Dispersion for injection, colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles in a multidose vial.

One dose (0.5 mL) contains 5 micrograms of the SARS-CoV-2 spike protein and is adjuvanted with Matrix-M

Administered intramuscularly

Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 18 years of age and older

In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.

Administered as a course of 2 doses (0.5 mL each) at such interval as may be specified in such recommendations or guidelines.

Notwithstanding any directions to the contrary in the summary of product characteristics—

(a) a dose may be administered as part of a heterologous primary schedule,

(b) an additional dose may be administered to immunocompromised persons who are 18 years of age or older and have already received a primary vaccine course against Covid-19, and

(c) a booster dose may be administered to—

(i) persons who are 18 years of age or older and have already received a primary vaccine course against Covid-19, and

(ii) immunocompromised persons who are 18 years of age or older and have already received an additional dose of a Covid-19 vaccine, in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.

Any suitable and appropriate place, having regard to public convenience and the need to protect the health and safety of the public and safely administer the product.

Medicinal product

Form and presentation of the product administered

Route of administration

Indication for which the medicinal product may be administered

Dosage and conditions of administration

Column 1

Column 2

Column 3

Column 4

Column 5

Nuvaxovid dispersion for injection

COVID-19 Vaccine (recombinant, adjuvanted)

Dispersion for injection, colourless to slightly yellow, clear to mildly opalescent dispersion free from visible particles in a multidose vial.

One dose (0.5 mL) contains 5 micrograms of the SARS-CoV-2 spike protein and is adjuvanted with Matrix-M

Administered Intramuscularly

Indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 18 years of age and older

In accordance with relevant recommendations or guidelines issued by the National Immunisation Advisory Committee and accepted by the Minister for Health.

Administered as a course of 2 doses (0.5 mL each) at such interval as may be specified in such recommendations or guidelines.

Notwithstanding any directions to the contrary in the summary of product characteristics—

(a) a dose may be administered as part of a heterologous primary schedule,

(b) an additional dose may be administered to immunocompromised persons who are 18 years of age or older and have already received a primary vaccine course against Covid-19, and

(c) a booster dose may be administered to—

(i) persons who are 18 years of age or older and have already received a primary vaccine course against Covid-19, and

(ii) immunocompromised persons who are 18 years of age or older and have already received an additional dose of a Covid-19 vaccine,

in such volumes, at such intervals, in such manner and in such order of prioritisation (whether by reference to age, employment sector, pregnancy or otherwise), as may be specified in such recommendations or guidelines, and subject to informed consent being obtained.