Novavax, Inc. has commenced a Phase 3 clinical trial to assess its COVID-19-Influenza Combination (CIC) vaccine and stand-alone seasonal influenza vaccine. The study, which began dosing participants on December 10, 2024, will evaluate the immunogenicity and safety of both vaccine candidates in comparison to Novavax's updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine. The trial is enrolling adults aged 65 and older.
The Phase 3 trial is a randomized study building upon positive Phase 2 data. It aims to further evaluate the combination of Novavax's updated COVID-19 vaccine, a trivalent nanoparticle stand-alone seasonal influenza vaccine candidate, and the Matrix-M adjuvant, relative to separate administrations of Novavax's updated COVID-19 vaccine and a licensed seasonal influenza vaccine. The trial will also assess the immunogenicity and safety of Novavax's stand-alone influenza vaccine, which also contains the Matrix-M adjuvant.
Regulatory and Partnership Strategy
Novavax is currently engaged with the U.S. Food and Drug Administration (FDA) to determine if the data from the ongoing CIC and stand-alone influenza trial can support an accelerated approval pathway. While these discussions are underway, Novavax plans to recruit an initial cohort of approximately 2,000 participants. The company anticipates providing further updates on potential next steps, including the need for additional clinical work, by the second quarter of 2025.
"A combination vaccine for two vaccine-preventable diseases is an important step forward for public health, and the trial start is a key step in advancing our late-stage pipeline, which we plan to progress through strategic partnerships," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President, Head of Research and Development, Novavax. "Our goal is to get these assets to market as soon as possible, and we will work with the U.S. FDA to assess the possibility of an accelerated approval pathway."
Novavax intends to pursue strategic partnerships to advance the filing and commercialization of both the CIC and stand-alone influenza vaccine candidates. The company's financial guidance for 2025 includes approximately $500 million for combined Research & Development and Selling, General and Administrative expenses, encompassing the initial Phase 3 clinical activities for these vaccines. This guidance is subject to revisions as the development plans progress.
Market Context and Competition
Novavax faces competition from other pharmaceutical companies in the development of combination vaccines. Moderna's mRNA-1083 candidate has shown statistically significant higher immune responses than existing vaccines in Phase 3 trials. Pfizer and BioNTech are also developing combination vaccines, though they encountered a setback when their candidate failed to meet one of its primary endpoints in a Phase 3 trial.
Sanofi has also entered the field, with the FDA granting fast-track designation to two of its experimental combination vaccines for COVID-19 and influenza, each being evaluated in separate phase I/II studies. One combination pairs Sanofi’s Fluzone HD vaccine with Novavax’s COVID-19 vaccine, while the other combines Sanofi’s Flubok influenza vaccine with the Novavax COVID-19 vaccine.
