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NUVAXOVID (Biocelect Pty Ltd)
Product name
NUVAXOVID
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
186 (255 working days)
Active ingredients
SARS-CoV-2 rS (NVX-CoV2373)
Registration type
NCE/NBE
Indication
NUVAXOVID (suspension for injection) is provisionally approved for 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.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration