COVID-19-Influenza Combination and Standalone Influenza Vaccines Generated a Strong Immune Response

In a late-stage trial, Novavax’s experimental COVID-19-influenza combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) vaccines generated a strong immune response in adults aged 65 and older, similar to already approved vaccines against the viruses.

The Phase III study involved approximately 2,000 participants and tested the safety and immune response of the CIC and tNIV vaccines compared to its COVID-19 vaccine Nuvaxovid and Sanofi’s flu shot Fluzone HD, respectively. Both tNIV and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline). And, both vaccine candidates were well-tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (>98 percent) solicited adverse events were mild or moderate in severity.

“Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well-tolerated,” said Ruxandra Draghia-Akli, MD, PhD, executive vice president and head of research and development at Novavax. “This data set adds to findings from our Phase II trial and will help inform discussions with potential partners.”

According to Novavax, the study was not designed to show statistically significant results. The data will be used to design a future late-stage study, which can be submitted for regulatory approval