US firm Novavax on 8 September announced that it has initiated an early stage to evaluate the safety and immunogenicity of a combined flu Novavax' seasonal influenza and COVID-19 vaccines.

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The trial, to be conducted in Australia, will enroll 640 healthy adults between the ages of 50 and 70 years and who have either been previously infected with the coronavirus or given an authorized COVID-19 vaccine at least eight weeks prior to the study. The clinical trial combines Novavax' recombinant protein-based NVX-CoV2373 and NanoFlu™ vaccine candidates and patented saponin-based Matrix-M adjuvant in a single formulation (COVID-NanoFlu Combination Vaccine).

Both NVX-CoV2373 and NanoFlu have previously demonstrated strong results as standalone vaccines in Phase 3 clinical trials, the company said in a statement. "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, MD, President of Research and Development, Novavax.

"The combination of these two vaccines, which have individually delivered outstanding results with favourable 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," Glenn added.

In preclinical studies, the COVID-NanoFlu Combination Vaccine demonstrated robust, functional immune responses to each component of the quadrivalent influenza vaccine and the SARS-CoV-2 spike protein, with Matrix-M adjuvant playing a key role. Novavax said it expects to start clinical studies of the combined vaccine by the end of 2021.