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Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand
- Submission to New Zealand's Medsafe marks the first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in New Zealand -
About this update from Novavax, Inc.
[{"type":"text","content":"- Submission to New Zealand's Medsafe marks the first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities in New Zealand\n- All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for Medsafe \n GAITHERSBURG, Md., Nov. 3, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the company has filed for provisional approval of the vaccine to the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). \n\"Today's submission marks Novavax' continued progress in bringing the first protein-based COVID-19 vaccine based on phase 3 data to the global community,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We remain laser-focused on delivering our vaccine, which is built on a proven, well-understood vaccine platform, and thank the Government of New Zealand for their ongoing partnership and confidence in our COVID-19 vaccine program.\"\nNovavax has now completed the submission to Medsafe of all modules required for the regulatory evaluation of NVX-CoV2373, a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. The chemistry, manufacturing and controls (CMC) module submitted to Medsafe, as well as other regulatory agencies worldwide, leverage Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.\nThe submission includes 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. Clinical data from a pivotal Phase 3 trial of 15,000 participants in the U.K. were also previously submitted to Medsafe, 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. In both trials, NVX-CoV2373 demonstrated a favorable safety and tolerability profile.\nNovavax recently announced regulatory filings for its vaccine in the United Kingdom, Australia, and...