Novavax on Wednesday said it completed a rolling regulatory submission to the UK Medicines and Healthcare products Regulatory Agency (MHRA) seeking authorisation for NVX-CoV2373, the company's recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant. "This submission brings [us] significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine," remarked CEO Stanley Erck.
Novavax added that it expects to complete additional regulatory filings in key regions, including Europe, Canada, Australia, New Zealand, the World Health Organization and other markets "shortly." Meanwhile, in the US, the company reiterated that it expects to submit a complete data package to the FDA by the end of the year.
Regarding the UK filing, Novavax said it has submitted all modules required by the MHRA for its NVX-CoV2373 review, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. Clinical data from a pivotal Phase III UK trial of 15,000 volunteers was submitted to the MHRA earlier this year in which NVX-CoV2373 demonstrated efficacy of 89.7% overall. The submission also includes data from PREVENT-19, a 30,000-volunteer trial in the US and Mexico, which demonstrated 90.4% efficacy overall and 100% protection against moderate and severe disease.
Earlier this month, Novavax shares were hit after a report said it was facing serious hurdles in proving to regulators that it could manufacture its COVID-19 vaccine candidate to meet quality standards. According to the report, one source familiar with Novavax's manufacturing process said purity levels for NVX-CoV2373 have come in at only around 70%, whereas purity levels would typically be expected to reach at least 90%.
Rick Crowley, chief operations officer at Novavax, noted Wednesday that the UK submission "leverages our manufacturing partnership with the Serum Institute of India," adding that "in the near future, we expect to supplement this filing with supply from our global supply chain."
To read more Top Story articles, click here.