Through its protein-based vaccine, NuvaxovidTM, the multinational biotechnology company Novavax has contributed significantly to Australia’s COVID-19 vaccination strategy. Biocelect Pty Ltd, Novavax’s Australian partner, has been crucial in navigating the regulatory environment and arranging clinical trials throughout the nation.
Clinical Trials and Regulatory Approvals
Australia has been pivotal in the clinical evaluation of Nuvaxovid™, hosting several Phase 1 and Phase 2 trials involving nearly 1,500 participants. These trials were conducted at 16 sites nationwide, with eight located in New South Wales, including institutions like UNSW Sydney’s Scientia Clinical Research and Paratus Clinical in Blacktown .Novavax Investor Relations | Novavax+2Novavax Investor Relations | Novavax+2NSW Health & Medical Research+2NSW Health & Medical Research
The Therapeutic Goods Administration (TGA) provisionally approved Nuvaxovid™ for adults in January 2022, marking it as the first protein-based COVID-19 vaccine authorized in Australia . Subsequent approvals included its use as a booster for adults in June 2022 and for adolescents aged 12-17 in July 2022 .Therapeutic Goods Administration (TGA)+3Novavax Investor Relations | Novavax+3Health.gov.au+3Novavax Investor Relations | Novavax+2Therapeutic Goods Administration (TGA)+2Therapeutic Goods Administration (TGA)+2
Manufacturing and Supply Chain
While Novavax does not have manufacturing facilities in Australia, it has established a robust supply chain through international partnerships. The Serum Institute of India, the world’s largest vaccine manufacturer by volume, has been a key partner, supplying initial doses of Nuvaxovid™ to Australia . This global collaboration ensured timely delivery and distribution of the vaccine across the country.Health.gov.au+9Novavax Investor Relations | Novavax+9Novavax Investor Relations | Novavax+9
Technological Innovation
Nuvaxovid™ utilizes Novavax’s proprietary recombinant protein-based nanoparticle technology, combined with the Matrix-M™ adjuvant derived from the bark of the Quillaja saponaria tree. This approach stimulates a robust immune response without using live virus components, offering an alternative for individuals hesitant about mRNA vaccines .Novavax Investor Relations | Novavax+4Novavax+4Novavax Investor Relations | Novavax+4
Future Outlook
Although Novavax ceased manufacturing its ancestral COVID-19 vaccine in early 2022, the company continues to innovate. Clinical trials are underway in Australia to evaluate Nuvaxovid™ as a booster and as part of a combination vaccine targeting both COVID-19 and seasonal influenza . These efforts underscore Novavax’s commitment to addressing current and emerging infectious disease threats.Health.gov.auNSW Health & Medical ResearchNovavax
Novavax’s journey in Australia exemplifies the power of international collaboration in addressing global health challenges. Through strategic partnerships, rigorous clinical research, and innovative technology, Novavax has contributed significantly to Australia’s pandemic response and continues to play a role in shaping the future of vaccine development.Novavax Investor Relations | Novavax+2