WEDNESDAY, SEPTEMBER 28, 2016

Novavax’s H7N9 vaccine fast-tracked by U.S. FDA

Novavax’s H7N9 vaccine fast-tracked by U.S. FDA

The latest avian influenza vaccine developed by Novavax is being fast-tracked by the U.S. Food and Drug Administration (FDA).
The new vaccine, Novavax’s H7N9 Virus-Like Particle Vaccine with Matrix-M, is being developed under the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA).

“The FDA’s fast track designation for our H7N9 VLP underscores the FDA’s recognition of the risk of H7N9 influenza, the lack of any approved vaccines for H7N9 influenza and the strength of our H7N9 VLP,” Novavax President and CEO Stanley C. Erck said. “This achievement is another example of the capabilities of our technology platform, the commitment of our people and the importance of our collaboration with BARDA.”

Thus far the clinical data from the new vaccine provides positive evidence from a Phase 1 study of 284 adult candidates. The vaccine had extraordinary positive results in just 180 days from the inoculation.

A Phase 2 trial consisting of 610 adults in September 2014 also resulted in positive data.

Both of these studies have shown that Novavax’s H7N9 VLP is the top H7N9 vaccine being developed in the medical industry.

The Fast Track Drug Development Program was implemented in 1997. This designation is reserved for developments against diseases that are considered serious and life-threatening.


Organizations in this story

Novavax 20 Firstfield Road Gaithersburg, MD 20878

U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903

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