First participants enrolled in Phase 1 clinical trial of NanoFlu combination vaccine^TM/NVX–CoV2373 with Matrix-M adjuvant^TM

Novavax, Inc. (Nasdaq: NVAX),a biotechnology company dedicated to the development and commercialization of next-generation vaccines for serious infectious diseases, today announced the enrollment of the first participants in a Phase 1 and 2 study to evaluate the safety and immunogenicity of a combination vaccine using Novavax's seasonal influenza and COVID-19 vaccines. Clinical trial combines Novavax's recombinant protein-based NVX-CoV2373 vaccine candidates, NanoFlu^TM and the patented Matrix-M adjuvant^TM based on saponins in a single formulation (combined COVID-NanoFlu vaccine). NVX-CoV2373 and NanoFlu have already produced excellent results as stand-alone vaccines in Phase 3 clinical trials.

"This study is the first of its kind to evaluate the vaccine's potential to induce a robust immune response, augmented by our Matrix-M adjuvant, against two life-threatening diseases simultaneously," said Gregory M. Glenn, M.D., president of research and development at Novavax. "The combination of these two vaccines, which have individually produced exceptional results with favorable safety and tolerability profiles, can lead to greater efficacy for the healthcare system and high levels of protection against COVID-19 and influenza with a single treatment."

The trial will evaluate the safety, tolerance and immune response of NanoFlu formulated with NVX-CoV2373 and the Matrix-M adjuvant in 640 healthy adults aged 50 to 70 years. Participants will have already been infected with the SARS-CoV-2 virus, which causes COVID-19, or vaccinated with an authorized vaccine at least eight weeks prior to enrollment in the study. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will receive one dose on day 0 and another dose on day 56. The trial will be conducted in Australia at up to 12 study sites, with results expected in the first half of 2022.

In preclinical studies,the combined COVID-NanoFlu vaccine demonstrated robust functional immune responses to each component of the quadrivalent influenza vaccine and the spike protein of SARS-CoV-2, with the Matrix-M adjuvant playing a key role.

In a Phase 3 clinical trial involving nearly 30,000 adults in the U.S. and Mexico, NVX-CoV2373 demonstrated full protection against moderate and severe COVID-19 infections and 90.4% overall efficacy. In a pivotal Phase 3 trial in adults 65 years of age and older, NanoFlu met the primary endpoints, demonstrating immunogenicity not inferior to an authorized comparator for the four influenza virus strains included in the vaccine, and both wild-type enhanced haemagglutination inhibition antibody responses against homologous and multiple heterologous A/H3N2 strains, and potent induction of T-cell responses.

NVX-CoV2373 was also evaluated in a concomitant administration study where it was administered simultaneously with an approved influenza vaccine. The study demonstrated that the effectiveness of the vaccine appeared to be preserved in those who received both vaccines compared to those who received NVX-CoV2373 only.