Consumer medicine information

1. Why am I being given NUVAXOVID?

NUVAXOVID contains the active ingredient SARS-CoV-2 rS (NVX-CoV2373). NUVAXOVID is a vaccine used to prevent COVID-19 disease caused by the SARS-CoV-2 virus in people aged 12 years and older.
For more information, see Section 1. Why am I being given NUVAXOVID? in the full CMI.

2. What should I know before I am given NUVAXOVID?

Do not use if you have ever had an allergic reaction to NUVAXOVID or any of the ingredients listed at the end of the CMI.
Talk to your healthcare provider if you have any other medical conditions, take any other medicines, have been given another vaccine or are pregnant or plan to become pregnant or are breastfeeding.
NUVAXOVID should not be given to children under 12 years of age.
For more information, see Section 2. What should I know before I am given NUVAXOVID? in the full CMI.

3. What if I am taking other medicines or vaccines?

Some medicines or vaccines may interfere with NUVAXOVID and affect how it works.
A list of these medicines and vaccines is in Section 3. What if I am taking other medicines or vaccines? in the full CMI.

4. How will I be given NUVAXOVID?

NUVAXOVID will be given as an injection into the muscle of your upper arm by a healthcare provider. You will be given one dose followed by a second dose 3 weeks later. It is very important that you receive your second dose. A healthcare provider will observe you for at least 15 minutes after being given NUVAXOVID.
You may receive an additional dose approximately 5-6 months after the primary vaccination.
More instructions can be found in Section 4. How will I be given NUVAXOVID? in the full CMI.

5. What should I know while being given NUVAXOVID?

6. Are there any side effects?

Very common side effects of NUVAXOVID include tenderness or pain at injection site, feeling tired, feeling unwell, headache, muscle ache, joint pain, nausea and vomiting
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

SARS-CoV-2 rS (NVX-CoV2373).

2 Qualitative and Quantitative Composition

These are multidose vials which contain 5 doses or 10 doses of 0.5 mL per vial (see Section 6.5 Nature and Contents of Container). One dose (0.5 mL) contains 5 micrograms of SARS-CoV-2 spike protein* and is adjuvanted with Matrix-M.
Adjuvant Matrix-M contains, per 0.5 mL dose: Quillaja saponaria saponins fraction A (42.5 micrograms) and Quillaja saponaria saponins fraction C (7.5 micrograms), see Section 6.5 Nature and Contents of Container.
* Produced by recombinant DNA technology using a baculovirus expressions system in an insect cell line that is derived from Sf9 cells of the Spodoptera frugiperda species.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Suspension for injection.
Nuvaxovid is colourless to slightly yellow, clear to mildly opalescent.

4 Clinical Particulars

4.9 Overdose

No case of overdose has been reported. In the event of an overdose, the individual should be monitored and provided with symptomatic treatment as appropriate.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. In vitro genotoxicity studies including bacterial reverse mutation, chromosomal aberrations in Chinese Hamster Ovary (CHO) cells and mammalian micronuclei in CHO cells were conducted with the Matrix-M adjuvant. The adjuvant was shown to be non-genotoxic.
Carcinogenicity. Carcinogenicity studies were not performed. The components of the vaccine are not expected to have carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (Schedule 4).

Summary Table of Changes

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