Novavax eyes NanoFlu phase 3 after besting Sanofi's Fluzone HD in seniors

vaccine
Novavax is weighing a phase 3 study for its NanoFlu vaccine for seniors after reporting positive topline phase 2 results. (Pixabay)

Seniors are a crucial group for flu vaccine makers because they're more likely to suffer from complications and are tougher to protect. And they're more likely to get their shots to boot. And now, Novavax reports that its four-strain NanoFlu bested Sanofi’s Fluzone High-Dose—designed for older patients—in a study focused on people 65 and older.

In top-line phase 2 results released Thursday, Novavax said trial participants on its vaccine had better hemagglutination inhibition antibody responses against several H3N2 flu viruses, including drifted strains, than Sanofi’s Fluzone HD. It also beat another flu shot in the same trial.

The company said it has identified a formulation for phase 3 testing and potential launch—and it's looking to launch that trial sometime this year. 

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The phase 2 trial tested NanoFlu with or without a Novavax adjuvant against two licensed flu vaccines in 1,375 people aged 65 and older, according to the biotech. The adjuvanted version performed significantly better than the version without an adjuvant, Novavax reported.

Looking ahead, Novavax plans to meet with the FDA to discuss the trial in the first half of 2019 and to start a pivotal phase 3 trial before year's end. The FDA has said NanoFlu could be up for accelerated approval, and that prospect will be part of Novavax's talks with the agency. 

RELATED: Novavax’s flu vaccine for older adults shows early promise against Sanofi’s Fluzone 

In a statement on the results, Novavax CEO Stanley Erck said the company intends to “advance to the market an improved vaccine that addresses the serious global public health threat that exists for older adults, and ultimately to make NanoFlu available to all populations.” 

In potentially launching its shot for older adults, the company would be taking on the top flu vaccine giants. Sanofi markets Fluzone High-Dose for older adults and in 2017 generated nearly €1.6 billion in total influenza vaccine sales. Seqirus’ Fluad is an adjuvanted option that generated $138 million in the company’s most recent fiscal year. 

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