Novavax Begins Phase 1/2 Study for Its Combination COVID-19 and Influenza Vaccine

The shot will be its NanoFlu/NVX-CoV2373 vaccine using the company’s Matrix-M adjuvant platform.

Gaithersburg, MD-based Novavax announced it had begun enrollment for its phase 1/2 study to evaluate the safety and immunogenicity of a combination vaccine using the Novavax seasonal influenza and COVID-19 vaccines.

"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," Gregory M. Glenn, MD, president of Research and Development, Novavax, said. "The combination of these two vaccines, which have individually delivered outstanding results with favorable safety and tolerability profiles, may lead to greater efficiencies for the healthcare system and achieve high levels of protection against COVID-19 and influenza with a single regimen."

Investigators are planning to study 640 healthy adults 50 to 70 years of age. Participants will have been either previously infected with the SARS-CoV-2 virus that causes COVID-19 or vaccinated through an authorized vaccine at least eight weeks prior to enrollment. All participants will be randomly assigned to cohorts to evaluate multiple formulations and will be dosed on Day 0 and again at Day 56. The trial will be conducted in Australia at up to 12 study sites.

Separately, their investigational influenza and COVID-19 vaccines have shown promising results in clinical trials.

NVX-CoV2373 demonstrated 100% protection against moderate and severe COVID-19 infection and 90.4% efficacy overall in phase 3 trial with nearly 30,000 adult participants in the US and Mexico.

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.

In a phase 3 trial using adults 65 years and older, NanoFlu achieved the primary endpoints, demonstrating non-inferior immunogenicity to a licensed comparator on all four influenza virus strains included in the vaccine, while also showing both enhanced wild-type hemagglutination-inhibiting antibody responses against homologous and multiple heterologous A/H3N2 strains, and potent induction of T cell responses.

The results for this latest study are expected during the first half of 2022.