On Sept. 23, 2021, Novavax with its partner, Serum Institute of India, announced a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. The submission to WHO is based on the companies’ previous regulatory submission to the Drugs Controller General of India(DCGI).

The grant of EUL by the WHO 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. In addition to the submission for WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data.

NVX-CoV2373 is being evaluated in two pivotal Phase 3 trials: a trial in the U.K. that 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; 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’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’ 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.

Novavax’ COVID-19 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.