Novavax has completed the rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of its Covid-19 vaccine candidate, NVX-CoV2373.
The company has submitted all the modules, including chemistry, manufacturing and controls (CMC) data, which are required to complete the regulatory review of the vaccine.
The clinical data from a pivotal Phase III PREVENT-19 study, which was conducted in 30,000 subjects in the US and Mexico, was also included in the submission.
In this trial, the recombinant nanoparticle protein-based vaccine has showed 90.4% overall efficacy and 100% protection against moderate and severe Covid-19 disease.
Previously, the Phase III clinical trial data, conducted in the UK in 15,000 participants, was also submitted to the WHO.
The vaccine NVX-CoV2373 demonstrated 89.7% overall efficacy, 86.3% efficacy against the Alpha (B.1.1.7) variant and 96.4% against the original virus.
Novavax president and CEO Stanley Erck said: “The 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.
“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.”
The company has also completed the regulatory filings in Australia, Canada, New Zealand and the UK for its vaccine.
All data and modules were also submitted in the European Union to support the final regulatory review process by the European Medicines Agency.
Novavax stated that the approval from the WHO enables the shipping of its Covid-19 vaccine doses to many countries which are participating in the COVAX Facility.