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Nuvaxovid
Published
Product name
Nuvaxovid
Active ingredient
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant spike protein (rS) with Matrix M adjuvant
Submission type
New biological entity
Decision
Approved for provisional registration
Decision date
Registration date
What this medicine was approved for
Nuvaxovid (SARS-CoV-2 rS with matrix M adjuvant (NVX-CoV2373)) was approved for the following therapeutic use:
Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
The decision has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer term efficacy and safety from ongoing clinical trials and post-market assessment.
How this medicine works
Nuvaxovid is composed of purified full length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant spike (S) protein that is stabilised in its prefusion conformation. The addition of the saponin based Matrix-M adjuvant facilitates activation of the cells of the innate immune system, which enhances the magnitude of the S protein specific immune response. The two vaccine components elicit B- and T-cell immune responses to the S protein, including neutralising antibodies, which protect against coronavirus disease.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Nuvaxovid was considered favourable for the therapeutic use approved.
Sponsor