Maryland's COVID-19 Vaccine Files with the WHO

Maryland-based Novavax, Inc. announced the completion of its rolling submission of NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate, to the World Health Organization (WHO) for emergency use listing (EUL).

Novavax has now completed the submission to WHO of all modules required for the regulatory evaluation of NVX-CoV2373.

The chemistry, manufacturing, and controls (CMC) module submitted to WHO and other regulatory agencies worldwide leverages Novavax's manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume.

Today's filing by Novavax is in addition to a previous filing to WHO by Novavax and SII.

Novavax recently announced the authorization of its vaccine in Indonesia.

The company also announced regulatory filings for its vaccine in the United Kingdom, Australia, New Zealand, and Canada and the complete submission of all data and modules in the European Union to support the final regulatory review of its dossier by the European Medicines Agency.

Novavax expects to submit the complete package to the U.S. FDA by the end of 2021.

"Today's 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," commented Stanley C. Erck, President and Chief Executive Officer, Novavax, in a press release.

The grant of 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.

Novavax continues to work closely with governments, regulatory authorities, and non-governmental organizations in its commitment to ensuring equitable global access to its COVID-19 vaccine.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that demonstrated the efficacy of 96.4% against the original virus strain, 86.3% against the Alpha (B.1.1.7) variant and 89.7% efficacy overall; and the PREVENT-19 trial in the U.S. and Mexico that demonstrated 100% protection against moderate and severe disease and 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response.

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.

NVX-CoV2373 was created using Novavax's recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax's patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 contains purified protein antigen and can neither replicate nor can it cause COVID-19.