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Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom
Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization All modules required for regulatory review, including CMC data, are now
About this update from Novavax, Inc.
[{"type":"text","content":"Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization All modules required for regulatory review, including CMC data, are now complete Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including against variants Submissions to additional global regulatory authorities including EU, Canada and Australia expected soon GAITHERSBURG, Md., Oct. 27, 2021 /PRNewswire/ -- 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 regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate. The company's application for Conditional Marketing Authorization (CMA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the United Kingdom.\n\n \n \n \n \n \n \n\n \n\"This submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus,\" said Stanley C. Erck, President and Chief Executive Officer, Novavax. \"We look forward to MHRA's review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision. We thank the clinical trial participants and trial sites in the United Kingdom, as well as the U.K. Vaccines Taskforce, for their support and vital contributions to this program.\"\nNovavax has now completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant. This includes preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase 3 trial of 15,000 volunteers in the U.K. was submitted to MHRA 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. The submission also includes data from PREVENT-19, a 30,000-person trial in the U....