Novavax Inc has completed its rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) for authorization of its COVID-19 vaccine candidate, according to the company. The application is the first submission for authorization of a protein-based COVID-19 vaccine in the United Kingdom, Novavax reports.
According to the company, it has completed the submission of all modules required by MHRA for the regulatory review of NVX-CoV2373, its 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 UK 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 US 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, the company reports.
“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.”
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.
The company expects to submit for FDA authorization by the end of the year, it said.