Product Dossier
NUVAXOVID
Product Dossier for NUVAXOVID (SARS-CoV-2 rS (NVX-CoV2373), Biocelect). ARTG record, PBS listing, PBAC outcomes, AusPAR — compiled by arcimedes.
- Sponsor: Biocelect
- Active ingredient: SARS-CoV-2 rS (NVX-CoV2373)
- Therapeutic area: Infectious Disease
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Nuvaxovid is a SARS-CoV-2 rS (NVX-CoV2373) COVID-19 vaccine adjuvanted suspension for injection supplied in vial form.
Approved indications
— Active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 12 years of age and older.
Dosing overview
The documents provided do not contain specific dosing information for Nuvaxovid.
Key safety warnings
The documents provided do not contain information regarding key safety warnings for Nuvaxovid.
Contraindications
The documents provided do not contain information regarding contraindications for Nuvaxovid.
PBS listing
The documents provided do not contain information regarding PBS listing for Nuvaxovid.
Regulatory history
Nuvaxovid was first listed on the ARTG on 20 January 2022. On 31 January 2024, the TGA approved Nuvaxovid for active immunisation to prevent COVID-19 in individuals 12 years of age and older, specifically extending the approved booster dose to adolescents aged 12 to less than 18 years. The TGA's evaluation focused on a major variation for a new dosage regimen extending the booster dose to adolescents, with quality and nonclinical aspects deemed satisfactory based on previous evaluations and the assessment primarily reviewing immunogenicity data from Study 2019nCoV-301 to support the proposed adolescent booster indication.