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The company reported interim results at a meeting this week showing multiple formulations were tolerable and safe. Next comes a phase 2 trial.
Novavax has announced interim results from its phase 1/2 clinical trial showing their investigative COVID-Influenza Combination Vaccine provided immunogenicity, safety and tolerability in early assessment.
The announcement of interim data brings promise for the initiation of a phase 2 trial confirming the dose of the novel vaccine product, which combines the company’s investigative COVID-19 vaccine NVX-CoV2373 with its quadrivalent flu vaccine candidate.
Investigators observed a safety and tolerability profile with the combination vaccine that was consistent with standalone administrations of the COVID-19 and flu vaccines, according to the company, with rare occurrences of serious adverse events—none of which were related to the combination vaccine.
On the basis of the trial’s modeling to observe various effects of different formulations of the combination vaccine, investigators reported preliminary findings suggesting various formulations provided immune responses in participants that were comparable to reference standalone flu and COVID-19 vaccine formulations.
Novavax additionally reported that modeling results suggest it may be possible to reduce total antigen counts by 50% overall with the combined formulation.
As the company plans to launch a phase 2 trial prior to the end of 2022, leadership expressed hope based on the early, preliminary findings.
"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," Gregory M. Glenn, MD, president of Research and Development at Novavax, said in a statement. "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."
The preliminary findings were presented at the World Vaccine Congress Washington 2022 meeting this week.