Artificial intelligence (AI) has been fundamental to the development of Novavax’s COVID-Influenza Combination (CIC) vaccine  reflecting a wider industry trend for increased usage of AI in clinical trial design, says GlobalData, a leading data and analytics company.

Novavax has recently announced topline results from a Phase II trial for its CIC vaccine. The data indicates that the vaccine candidate is safe, well tolerated, and exhibits a strong immune response comparable to that of both influenza vaccines Fluad and Fluzone HD, as well as Novavax’s COVID-19 vaccineNVX-CoV2373.

Stephanie Kurdach, Infectious Disease Analyst at GlobalData, comments: “Novavax’s novel AI approach, which informed dose selection of the CIC vaccine candidate, is paying off. With Phase III trials set to begin later this year, Novavax has a good chance to bring the first combined COVID-Influenza vaccine to market.”

The CIC vaccine has three components – recombinant hemagglutinin (rHA) particles from four prominent influenza strains (H1N1, H3N2, B-Yamagata, and B-Victoria), recombinant spike (rS) nanoparticles from SARS-CoV-2, and Novavax’s Matrix-M adjuvant.

A design of experiments (DoE) approach was used to predict appropriate dosing combinations to immunize patients and response surface modelling following immunization responses. By simultaneously altering the rS and rHA doses within the model, it was possible to observe the antibody responses among each of the four influenza strains and SARS-CoV-2.

The DoE software enabled more powerful fine-tuning of dose selection of the COVID-19 and influenza antigens compared to conventional methods. The CIC formulation determined by the DoE software implies up to a 50% reduction in total antigen content. Reduced antigen content in vaccines has been found to be equally as immunogenic, with increased tolerability for patients.

Kurdach continues: “The novel approach employed by Novavax is an exciting advance in vaccinology. Integrating AI methodologies into clinical trials has the potential to speed up existing processes, aid in decision making, and reduce possible instances of human error.”

Novavax’s trial design reflects a wider industry trend, as pharmaceutical companies are becoming highly active in utilizing AI technologies. It follows other companies such as AstraZeneca, Moderna, and Pfizer – all of whom referenced AI-methods during clinical trials for their COVID-19 vaccines.

GlobalData confirms that patent activity by pharmaceutical companies using AI reached an all-time high in 2022 – accounting for 61 patent grants, 225 patent filings, and 299 patent publications. Furthermore, there have been over 600 AI-related filings involving pharmaceutical companies in the last six months.

Kurdach concludes: “AI algorithms are responsible for increasing efficiency of mRNA sequence design and antigen detection. Without AI methodologies, there would not have been such a speedy vaccine response to the COVID-19 pandemic.”