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Novavax Launches Phase 3 Trial for COVID-19-Influenza Combination Vaccine

Novavax has initiated a Phase 3 clinical trial for its COVID-19-Influenza Combination (CIC) vaccine and a stand-alone influenza vaccine, targeting adults aged 65 and older. The trial aims to evaluate the immunogenicity and safety of these vaccines compared to existing options. Novavax is also exploring an accelerated approval pathway with the U.S. FDA.

Novavax Advances Vaccine Development with Phase 3 Trial

Novavax, Inc. has announced the commencement of a Phase 3 clinical trial for its COVID-19-Influenza Combination (CIC) vaccine and a stand-alone seasonal influenza vaccine. This significant step forward in vaccine development targets adults aged 65 and older, a demographic particularly vulnerable to severe outcomes from these diseases.

Trial Objectives and Design

The trial is designed to assess the immunogenicity and safety of the CIC vaccine and the stand-alone influenza vaccine. These will be compared against Novavax's updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine. The study builds on positive Phase 2 data and incorporates Novavax's patented Matrix-M adjuvant to enhance immune response.

Accelerated Approval Pathway

Novavax is in discussions with the U.S. Food and Drug Administration (FDA) to explore the possibility of an accelerated approval pathway for these vaccines. The company has initiated the trial with an initial cohort of approximately 2,000 participants while continuing these discussions. Novavax anticipates providing more detailed information on the trial's progress and potential next steps by the second quarter of 2025.

Strategic Partnerships and Financial Outlook

The development of these vaccine candidates is part of Novavax's strategy to advance its late-stage pipeline through strategic partnerships. The company's financial guidance for fiscal year 2025 includes approximately $500 million in combined Research & Development and Selling, General, and Administrative expenses, covering the initial Phase 3 clinical activities for the CIC and stand-alone influenza vaccines.

About Novavax

Novavax, Inc. is a global company based in Gaithersburg, Maryland, dedicated to improving health through the discovery, development, and commercialization of innovative vaccines. The company's portfolio includes a COVID-19 vaccine and a pipeline featuring the CIC and stand-alone influenza vaccine candidates. Novavax's vaccine platform combines a recombinant protein approach with innovative nanoparticle technology and the Matrix-M adjuvant to enhance immune responses.
For more information, visit Novavax's website and follow the company on LinkedIn.
Note: This article is based on information provided by Novavax, Inc. and does not include promotional content.
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Reference News

[1]
Novavax Initiates Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza
br.advfn.com · Jan 13, 2025

Novavax has begun a Phase 3 trial for its COVID-19-Influenza Combination and stand-alone influenza vaccines, aiming for ...

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