Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia

01 November 2021 | Monday | News

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today 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 marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia.
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-- Application marks the first protein-based COVID-19 vaccine submitted to regulatory authorities for provisional approval in Australia 

-- In addition to today's submission to the Therapeutic Goods Administration, the company recently filed for authorization with MHRA, with additional filings in process 

-- All modules required for Australian regulatory evaluation, including Quality/ CMC data, are now complete 


"This submission brings Novavax significantly closer to delivering doses of the first protein-based COVID-19 vaccine to Australia and, along with this week's filing for conditional marketing authorization in the U.K., brings us one step closer to our goal of ensuring broad global access to our vaccine," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the Australian clinical trial participants and trial sites, as well as the regulatory and vaccine experts, for their assistance and contribution to this vaccine program."

Australia has played 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 EuropeCanadaNew 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.

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