On Oct. 29, 2021, Novavax announced the completion of its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its COVID-19 vaccine candidate. The company’s application to the TGA marked the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia.

Australia layed a pivotal role in the Phase 1 and Phase 2 clinical trials supporting the development of NVX-CoV2373, the company’s recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. Additional booster trials and a Phase 1/2 trial for a combination vaccine using Novavax’ seasonal influenza and COVID-19 vaccine are underway in Australia.

Novavax has now completed the submission of all modules required by the TGA for the regulatory evaluation of its COVID-19 vaccine. This includes preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. was submitted to the TGA earlier this year in which NVX-CoV2373 demonstrated efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall, as well as a favorable safety and tolerability profile. Clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall, was also submitted to the TGA.

Novavax recently filed for conditional marketing authorization in the U.K. and expects to shortly complete additional regulatory filings in key markets, including Europe, Canada, New Zealand and the World Health Organization, as well as other markets around the world. In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year.

This submission was facilitated by the Company’s local partner, Biocelect Pty. Ltd., as sponsor. The submission to TGA leverages Novavax’ manufacturing partnership with the Serum Institute of India, the world’s largest supplier of COVID-19 vaccines, and will later be supplemented with additional global supply chain.