It comes on the back of receiving the first regulatory authorization for its vaccine, which was granted in Indonesia last week. The company has also made regulatory filings for its vaccine in the UK, Australia, New Zealand and Canada and the EU. It expects to submit the complete package to the US Food and Drug Administration (FDA) by the end of the year.
The grant of an WHO EUL is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.
"This submission reflects our continued focus on accelerating access and equitable distribution as we work to bring our vaccine to people in need around the globe," said Stanley C. Erck, president and CEO, Novavax, as the company announced the completed submission last Thursday. "We continue to work with urgency to deliver our COVID-19 vaccine, built on a proven, well-understood vaccine platform, because no one is safe until everyone is safe."
Novavax has now completed the submission to WHO of all modules required for the regulatory evaluation of its COVID-19 vaccine: a recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.
The chemistry, manufacturing and controls (CMC) module submitted to WHO, as well as other regulatory agencies worldwide, is based on Novavax's manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume.
Further submissions will follow to enable vaccine supply from additional manufacturing sites in Novavax’s global supply chain.
The submission also includes clinical data from PREVENT-19, a pivotal Phase 3 trial of 30,000 participants in the US 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 UK were also previously submitted to WHO, 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.
The vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.
