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
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