Novavax's Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial

Novavax, Inc. (NASDAQ:NVAX) announced results Wednesday of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial.

The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid and Sanofi SA’s (NASDAQ:SNY) Fluzone HD, respectively.

Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).

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“Both our combination and standalone flu vaccine candidates induced robust immune responses and were well tolerated,” said Ruxandra Draghia-Akli, executive vice president and head of Research and Development at Novavax.

“This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners.”

Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators.

Nearly all (>98%) solicited adverse events were mild or moderate in severity. 

The cohort was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.

The descriptive trial evaluated the safety and immunogenicity of the CIC and standalone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older.

This trial was not adequately powered to demonstrate statistical significance.

In May 2023, Novavax unveiled data for its COVID-influenza combination vaccine and two other shots.

Data from a Phase 2 trial in adults aged 50-80 showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots.

The study found that all three of Novavax’s vaccine candidates—the COVID/flu combination shot, a standalone flu shot, and a higher dose of its COVID shot—were safe and well-tolerated.

In May, Novavax received limited approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Nuvaxovid. This marked a regulatory milestone and unlocking a $175 million milestone payment from partner Sanofi.

Earlier in June, the FDA approved Moderna, Inc.'s (NASDAQ:MRNA) mNexspike (mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).

Price Action: NVAX stock is up 0.56% at $7.24 at the last check on Wednesday.

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