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Novavax vaccine NanoFlu elicits 'vigorous' immune responses in mid-stage trial

Novavax Inc. said its vaccine NanoFlu "elicited vigorous immune responses" to four influenza virus strains in a mid-stage trial.

The phase 2 study evaluated various formulations of NanoFlu against Sanofi's Fluzone High-Dose in 1,375 healthy adults aged 65 years and older. NanoFlu was significantly better than Fluzone High-Dose at preventing influenza virus strains from binding with red blood cells.

Certain patients received NanoFlu with Novavax's Matrix-M adjuvant, an additional treatment which boosts antibody production and prolongs protection against viral and bacterial infections, as well as significantly reduces vaccine manufacturing costs. Patients treated with the Matrix-M formulation had significantly enhanced immune responses compared to patients who received NanoFlu alone.

Additionally, Novavax said all formulations of NanoFlu were well-tolerated.

The Gaithersburg, Md.-based vaccine maker said NanoFlu more effectively addresses the mismatch between circulating viruses and the strains included in most commercial vaccines, which is due to genetic drift and vaccine virus egg adaptation. "Older adults experienced the brunt of the serious health consequences of this mismatch," Gregory Glenn, president of research and development at Novavax, said in a news release. Glenn said majority of influenza hospitalizations and death during 2017 to 2018 — the worst flu season in four decades — were due to influenza A virus subtype H3N2.

Novavax said it identified the NanoFlu formulation that it will evaluate in a phase 3 trial and eventually commercialize.

The U.S. Food and Drug Administration previously granted NanoFlu an accelerated approval pathway, which could allow the drug to be licensed sooner. Novavax said it will meet with the regulator again in the first half of 2019 to discuss the phase 2 study results, the proposed phase 3 trial design and the use of accelerated approval.

About one million people die each year due to influenza, according to Novavax. The top seven markets for seasonal influenza vaccines are expected to grow to $5.3 billion by 2021, from about $3.2 billion in 2015.