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.