Novavax, Inc. has released the results of the initial cohort of its COVID-19-influenza combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (TNIV) phase 3 trial. The data showed that both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid® and Fluzone HD, respectively.
The trial, designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older, revealed some compelling findings. Both the stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains, with increases ranging from 2.4 to 5.7-fold over baseline.
Furthermore, the results indicated that no new safety signals were observed, and both vaccine candidates were well tolerated, consistent with past trials. Reactogenicity was comparable to authorized comparators, with nearly all (>98%) solicited adverse events being mild or moderate in severity.
Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development at Novavax, commented on the results, stating, "Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated. This data set adds to findings from our phase 2 trial and will help inform discussions with potential partners."
It's noteworthy that this trial was not adequately powered to demonstrate statistical significance, but these results build on previous phase 2 data.
Novavax, Inc. (NASDAQ: NVAX) is known for tackling pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M® adjuvant. The company's growth strategy seeks to optimize its existing partnerships, expand access to its proven technology platform, and forge new partnerships and collaborations with other companies. Today the company's shares have moved -2.83% to a price of $7.20. Check out the company's full 8-K submission here.