Novavax files for authorization of its COVID-19 Vaccine, NVX-CoV2373.

Novavax, Inc. has 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.

Novavax 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 III 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.S. and Mexico, which demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. NVX-CoV2373 was generally well-tolerated and elicited a robust antibody response.

Novavax expects to complete additional regulatory filings in key markets, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets around the world shortly following the U.K. submission.

In the U.S., Novavax expects to submit the complete package to the FDA by the end of the year. The company continues to work closely with governments, regulatory authorities and non-governmental organizations (NGOs) in its commitment to ensuring equitable global access to its COVID-19 vaccine.