Novavax Announces Initiation of Phase 2 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza Vaccine Candidates


The COVID-19-Influenza Combination (CIC) and influenza stand-alone vaccine candidates will now be tested in a Phase 2 trial, according to Novavax, Inc., a biotechnology company committed to creating and marketing next-generation vaccines for critical infectious diseases. The CIC and influenza vaccine candidates will be evaluated for safety and efficacy (immunogenicity) in individuals aged 50 to 80 during the dose-confirming phase.

“We’re encouraged by the initiation of this trial given the positive results shared earlier this year from our Phase 1/2 trial, the first of its kind to evaluate a combined COVID-19 and influenza vaccine”, “We believe that like influenza, COVID-19 will also be seasonal moving forward, and that there is room in the market for new alternatives to provide better protection against the impact of influenza, particularly in older adults, and to explore the potential to combine this with protection from COVID.”

Stanley C. Erck, President and Chief Executive Officer, Novavax

The quadrivalent influenza vaccine candidate from Novavax, the recombinant protein-based COVID-19 vaccine (NVX-CoV2373), and the patented saponin-based Matrix-MTM adjuvant will all be evaluated in the randomised, observer-blinded experiment. Assessing the safety, tolerability, and immunological responses to various formulations of the CIC and influenza vaccine candidates is one of the study’s primary and secondary goals. A total of over 2,300 participants will be enrolled in the Phase 2 dose-confirmation experiment over two phases at various sites in Australia and New Zealand.

Initial trial findings are anticipated in the middle of 2023. Both the influenza stand-alone and COVID-19-influenza combo Phase 3 trials will benefit from these data.

About NVX-CoV2373

A protein-based vaccination called NVX-CoV2373 was created using the genetic code from the initial strain of SARS-CoV-2, the virus that causes COVID-19 sickness. The vaccine was developed using Novavax’s recombinant nanoparticle technology to produce antigen derived from the coronavirus spike protein. Novavax’s patented saponin-based Matrix-MTM adjuvant is used in the formulation of the vaccine to boost the immune response and stimulate high levels of neutralising antibodies. Purified protein antigen is present in NVX-CoV2373, which is unable to replicate or produce COVID-19.

The vaccine may be distributed using the current cold chain and vaccine supply systems because it is packaged as a ready-to-use liquid formulation and stored between 2 and 8 degrees Celsius. Follow official recommendations while administering the vaccination.

For the production, marketing, and global distribution of NVX-CoV2373, Novavax has formed partnerships. Existing authorizations make use of Novavax’s production alliance with Serum Institute of India, the largest volume producer of vaccines in the world. Later, data from more production facilities along the entire global supply chain of Novavax will be added to them.

About Matrix-MTM Adjuvant

By encouraging the entry of antigen-presenting cells into the injection site and improving antigen presentation in nearby lymph nodes, Novavax’s patented saponin-based Matrix-M adjuvant has shown to have a powerful and well-tolerated impact. This increases immune response.

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