Novavax Reports its COVID-19 Influenza Combination Vaccine is Well-Tolerated, Provides Immune Response

The company said yesterday results from the phase 1/2 clinical trial studying their COVID-influenza combination vaccine (CIC), demonstrated an immunological response and was safe. The preliminary trial results found that various CIC vaccine formulations induced immune responses in participants comparable to reference stand-alone influenza and stand-alone COVID-19 vaccine formulations (for H1N1, H3N2, B-Victoria HA and SARS-CoV-2 rS antigens). Modeling results also showed that a combined formulation has the potential to reduce total antigen amount by up to 50% overall, optimizing production and delivery.

The preliminary findings were presented at the World Vaccine Congress Washington 2022 meeting this week.

"We're encouraged by these data and the potential path forward for a combination COVID-19-influenza vaccine as well as stand-alone vaccines for influenza and COVID-19," Novavax President of Research and Development Gregory M. Glenn, MD, said in a statement.

The investigational vaccine combines the company’s COVID-19 vaccine, NVX-CoV2373, and its quadrivalent influenza vaccine candidate.

A design of experiments modeling-based approach was used to design the trial, enabling more powerful fine-tuning of dose selection of both the COVID-19 and influenza antigens for further development compared to traditional approaches.

The company is developing this combination vaccine with an eye towards boosters being needed on an annual basis.

"We continue to evaluate the dynamic public health landscape and believe there may be a need for recurrent boosters to fight both COVID-19 and seasonal influenza," Glenn stated.

At the aforementioned conference, Novavax reviewed key findings from the phase 3 trial of its stand-alone influenza candidate, which met its primary immunogenicity endpoint. These results were published earlier this year in The Lancet.