Right now, the U.S. government is in search of an H7N9 vaccine that can reach the market to help prevent against a potential pandemic. And a new FDA fast-track designation for Novavax's ($NVAX) candidate might help it get there a little sooner.
Thursday, the agency handed the Maryland biotech a fast-track designation for its virus-like particle vaccine candidate. Novavax is developing the investigational vaccine under the company's 2011 contract with HHS' Biomedical Advanced Research and Development Authority (BARDA), which awarded funding of up to $97 million.
"The FDA's fast-track designation for our H7N9 VLP underscores the FDA's recognition of the risk of H7N9 influenza, the lack of any approved vaccines for H7N9 influenza and the strength of our H7N9 VLP," Novavax CEO Stanley Erck said in a statement. "This achievement is another example of the capabilities of our technology platform, the commitment of our people and the importance of our collaboration with BARDA."
So far, Novavax's prospect has charted positive results in both a Phase I study released last November and a Phase II trial, data from which the company announced in September.NIAID Director Dr. Anthony Fauci
But the Gaithersburg-based company is not the only one to post positive Phase II results. Earlier this month, the NIH found that Sanofi's ($SNY) H7N9 vaccine prompted an immune response in 59% of the 700 participating healthy adults when mixed with Novartis' ($NVS) MF59 adjuvant.
While the number of reported avian flu cases has dropped off significantly since the virus last year surfaced in humans in China, it can still cause serious illness, which has prompted the U.S. government's search for a protective vaccine. "All novel influenza viruses have the potential to evolve to cause widespread illness or death," Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases (NIAID), said in recent statement.
- read Novavax's release
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