Novavax begins dosing in COVID-19-influence and season influenza Phase 3 trial

Novavax (NVAX) announced that the first participants have been dosed in its COVID-19-Influenza Combination and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax’s updated 2024-2025 COVID-19 vaccine, NVX-CoV2705, and a licensed seasonal influenza vaccine comparator in adults aged 65 and older. The company is working with the FDA to determine the potential of the current CIC and stand-alone influenza trial to support accelerated approval. Novavax anticipates being able to provide more clarity and information on potential next steps by Q2 2025, including if additional clinical work would be needed to achieve registration for these assets. The randomized Phase 3 trial builds on positive Phase 2 data and aims to further evaluate the immunogenicity and safety of a combination of Novavax’s updated 2024-2025 COVID-19 vaccine, trivalent nanoparticle stand-alone seasonal influenza vaccine candidate and patented saponin-based Matrix-M adjuvant relative to separate administrations of Novavax’s updated 2024-2025 COVID-19 vaccine and a licensed seasonal influenza vaccine comparator. In addition, the trial also aims to further evaluate the immunogenicity and safety of Novavax’s stand-alone influenza vaccine, also containing Matrix-M. The company’s FY 2025 financial guidance for combined R&D and Selling, General and Administrative expense of approximately $500M is inclusive of this CIC and stand-alone influenza initial planned Phase 3 clinical activity and is subject to revisions and updates as next steps are determined.