Coronavirus (COVID-19) health alert

Japanese encephalitis virus (JEV) health alert

Clinical guidance for COVID-19 vaccine providers

COVID-19 vaccine doses and administration

The following COVID-19 vaccines have been provisionally approved for use in Australia. Find out their dosage, volume and schedules.

Pfizer original ≥12 years dilute-to-use formulation (purple cap)

Brand name Comirnaty, generic name tozinameran or BNT162b2

Category	Detail
Sponsor	Pfizer Australia Pty Ltd
Approved age for use	≥12 years
Presentation	Multidose vial without preservative. Each vial contains 6 doses in 0.45 mL. Requires dilution with 1.8 mL of sterile 0.9% NaCl without preservative into each multidose vial
Cap colour	Purple
Volume/strength	0.3 mL (30 µg) per dose
Schedule	2 doses, 3 to 8 weeks apart (primary course)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.3 mL dose contains 30 µg mRNA encoding the SARS-CoV-2 spike glycoprotein
Excipients	((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) distearoylphosphatidylcholine (DSPC) cholesterol potassium chloride monobasic potassium phosphate sodium chloride dibasic sodium phosphate dihydrate sucrose water for injection

Pfizer 5 to 11 years formulation (orange cap)

Brand name Comirnaty, generic name tozinameran or BNT162b2

Category	Detail
Sponsor	Pfizer Australia Pty Ltd
Approved age for use	5 to <12 years
Presentation	Tris/sucrose presentation. Multidose vial containing 10 doses in 1.3 mL. Requires dilution with 1.3 mL of sterile 0.9% NaCl without preservative into each multidose vial
Cap colour	Orange
Volume/strength	0.2 mL (10 µg) per dose
Schedule	2 doses, 8 weeks apart (primary course)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.2 mL dose contains 10 µg mRNA encoding the SARS-CoV-2 spike glycoprotein
Excipients	((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) distearoylphosphatidylcholine (DSPC) cholesterol trometamol trometamol hydrochloride sucrose water for injection

Pfizer 6 months to 4 years formulation (maroon cap)

Brand name Comirnaty, generic name tozinameran or BNT162b2

Category	Detail
Sponsor	Pfizer Australia Pty Ltd
Approved age for use	6 months to <5 years
Presentation	Tris/sucrose presentation. Multidose vial containing 10 doses in 0.4 mL. Requires dilution with 2.2 mL of sterile 0.9% NaCl without preservative into each multidose vial
Cap colour	Maroon
Volume/strength	0.2 mL (3 µg) per dose
Schedule	3 doses, each dose 8 weeks apart (primary course)
Administration route	For infants aged 6 to 12 months: Intramuscular injection into vastus lateralis muscle of the anterolateral thigh For children aged ≥12 months: Intramuscular injection into deltoid muscle (or into the vastus lateralis muscle of the anterolateral thigh)
Ingredients	Each 0.2 mL dose contains 3 µg mRNA encoding the SARS-CoV-2 spike glycoprotein
Excipients	((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) distearoylphosphatidylcholine (DSPC) cholesterol trometamol trometamol hydrochloride sucrose water for injection

Pfizer bivalent original/Omicron BA.1 ≥18 years formulation (grey cap)

Brand name Comirnaty, generic name tozinameran or BNT162b2 (OMI) BA.1

Category	Detail
Sponsor	Pfizer Australia Pty Ltd
Approved age for use	≥18 years
Presentation	Multidose vial containing 6 doses in 2.25 mL. Does not require dilution
Cap colour	Grey. Note that Pfizer bivalent original/Omicron BA.4/5 ≥ 12 years formulation also has a grey cap. To minimise the risk of administration errors, providers should preferably prepare and store doses of these vaccines separately. Doses withdrawn in advance of administration should be clearly labelled.
Volume/strength	0.3 mL (30 µg) per dose
Schedule	2 doses, 8 weeks apart (primary course) 1 dose (booster)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.3 mL dose contains 15 µg of tozinameran and 15 µg of riltozinameran
Excipients	((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) distearoylphosphatidylcholine (DSPC) cholesterol trometamol trometamol hydrochloride sucrose water for injection

Pfizer bivalent original/Omicron BA.4/5 ≥12 years formulation (grey cap)

Brand name Comirnaty, generic name tozinameran/famtozinameran

Category	Detail
Sponsor	Pfizer Australia Pty Ltd
Approved age for use	≥12 years
Presentation	Multidose vial containing 6 doses in 2.25 mL. Does not require dilution
Cap colour	Grey. Note that Pfizer bivalent original/Omicron BA.1 ≥ 18 years formulation also has a grey cap. To minimise the risk of administration errors, providers should preferably prepare and store doses of these vaccines separately. Doses withdrawn in advance of administration should be clearly labelled.
Volume/strength	0.3 mL (30 µg) per dose
Schedule	2 doses, 8 weeks apart (primary course) 1 dose (booster)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.3 mL dose contains 15 µg of tozinameran and 15 µg of famtozinameran
Excipients	((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis (2-hexyldecanoate) (ALC-0315) 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) distearoylphosphatidylcholine (DSPC) cholesterol trometamol trometamol hydrochloride sucrose water for injection

Moderna bivalent original/Omicron BA.1 ≥18 years (blue cap/green label)

Brand name Spikevax generic name elasomeran/imelasomeran or mRNA-1273.214

Category	Detail
Sponsor	Moderna Australia Pty Ltd
Approved age for use	≥18 years
Presentation	2.5 mL multidose vial without preservative
Cap colour	Blue cap/green label. Note that the Moderna 6 months to 5 years formulation (blue cap/purple stripe) also has a blue cap. To minimise the risk of administration errors, providers should preferably prepare and store doses of these vaccines separately. Doses withdrawn in advance of administration should be clearly labelled.
Volume/strength	0.5 mL (50 μg) per dose
Schedule	2 doses, 8 weeks apart (primary course) 1 dose (booster)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.5 mL dose contains 25 μg elasomeran (ancestral SARS-CoV-2) and 25 μg imlasomeran (Omicron BA.1 subvariant)
Excipients	heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate cholesterol distearoylphosphatidylcholine 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000-DMG) trometamol trometamol hydrochloride acetic acid sodium acetate trihydrate sucrose water for injection

Moderna bivalent original/Omicron BA.4/5 ≥12 years (pre-filled syringe)

Brand name Spikevax, generic name elasomeran/davesomeran or mRNA-1273.222

Category	Detail
Sponsor	Moderna Australia Pty Ltd
Approved age for use	≥12 years
Presentation	0.5 mL pre-filled syringe
Volume/strength	0.5 mL (50 μg) per dose
Schedule	2 doses, 8 weeks apart (primary course) 1 dose (booster)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.5 mL dose contains 25 μg elasomeran (ancestral SARS-CoV-2) and 25 μg davesomeran (Omicron BA.4/5 subvariants)
Excipients	heptadecan-9-yl 8-[2-hydroxyethyl-(6-oxo-6-undecoxyhexyl)amino]octanoate cholesterol distearoylphosphatidylcholine 1,2-dimyristoyl-rac-glycero-3-methoxypolyethylene glycol-2000 (PEG2000-DMG) trometamol trometamol hydrochloride acetic acid sodium acetate trihydrate sucrose water for injection

Novavax – brand name Nuvaxovid, generic name NVX-CoV2373

Category	Detail
Sponsor	Biocelect Pty Ltd on behalf of Novavax Ltd
Approved age for use	≥12 years
Presentation	Multidose vial without preservative, each vial containing 10 doses in 5 mL
Volume/strength	5 µg antigen, 50 µg Matrix-M
Schedule	2 doses, 3 to 8 weeks apart (primary course)
Administration route	Intramuscular injection into deltoid muscle
Ingredients	Each 0.5 mL dose contains 5 µg of SARS-CoV-2 spike protein, adjuvanted with Matrix-M. Adjuvant Matrix-M contains Fraction-A (42.5 µg) and Fraction-C (7.5 µg) of Quillaja saponaria Molina extract
Excipients	dibasic sodium phosphate heptahydrate monobasic sodium phosphate monohydrate sodium chloride polysorbate 80 sodium hydroxide (for adjustment of pH) hydrochloric acid (for adjustment of pH) water for injection adjuvant (Matrix M) Quillaja saponaria saponins fraction A Quillaja saponaria saponins fraction C cholesterol phosphatidyl choline monobasic potassium phosphate potassium chloride

Last updated:

5 June 2023

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