Novavax, Inc. participated in the U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting which resulted in a 19-2 vote to recommend inclusion of a SARS-CoV-2 Omicron component for COVID-19 booster vaccines in the U.S. beginning this fall. During the meeting, Novavaxhighlighted data showing that the structural features of Novavax' protein-based COVID-19 vaccine, enhanced by the Matrix-M™ adjuvant, displayed epitopes across both the original strain and emerging variants, contributing to the generation of broadly cross-reacting antibodies. Additional data from Phase 2 and Phase 3 trials, as well as in vitro data on neutralizing antibodies and receptor inhibition from trial participants, show cross-reactivity with all variants tested, particularly following booster doses.

Novavax presented preclinical trial data showing that boosting with either the prototype (NVX-CoV2373), Omicron BA.1 (NVX-CoV2515), or bivalent vaccine generated antibody levels that were consistent with dosing regimens in the Phase 3 clinical trials. While boosting with the prototype covers all strains, providing an Omicron booster enhances immunity to related Omicron sub-variants. Boosting with a bivalent vaccine containing prototype and Omicron BA.1 showed no advantages in any of the responses compared to boosting with BA.1 alone.

A clinical trial is ongoing with results anticipated in September and product availability expected in fourth quarter. Novavax submitted a request to the FDA for Emergency Use Authorization (EUA) in January 2022. The VRBPAC Committee voted 21 to 0 with one abstention on June 7, 2022, to recommend that the FDA grant EUA for NVX-CoV2373 for individuals aged 18 years and over.

The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine 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.

The 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 mcg antigen and 50 mcg 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.

Use of the vaccine should be in accordance with official recommendations. Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume.

They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain.