Novavax achieves milestone in novel H1N1 influenza vaccine technology
17 August 2009
Novavax, Inc. (NASDAQ: NVAX) has announced that it has manufactured a virus-like particle (VLP) vaccine candidate against the H1N1 pandemic influenza virus under current good-manufacturing practices (cGMP) at its new vaccine manufacturing facility in Rockville, MD.
This milestone was accomplished in only 11 weeks after receiving the gene sequence for the H1N1 strain from the US Centers for Disease Control. The Company was able to reach this manufacturing goal by employing proprietary, novel production technology which is not dependent on growing influenza virus in eggs.
Chicken eggs are used to produce almost all of the world's influenza vaccine supply. In addition, Novavax has produced essential reagents for measuring vaccine potency. The Company also has plans to produce additional batches of the pandemic H1N1 VLP vaccine to support human clinical studies and stands ready to assist with additional public health needs in the US as well as foreign countries.
A detailed timeline describing the process from gene sequence to cGMP manufacturing is available on the Novavax website (www.Novavax.com).
Mr. Jim Robinson, Vice President of Manufacturing and Quality Operations at Novavax, commented, "Demonstration of our ability to construct and produce GMP-quality influenza vaccine within 12 weeks under real pandemic conditions is an important and successful test of our VLP technology. With further scale up, recombinant influenza VLP vaccine technology has the potential to expand vaccine surge capacity and significantly reduce the timeline for vaccine release. We are proud of our staff who worked tirelessly to achieve this important milestone while working concurrently to produce materials for a clinical study in the elderly population with our Seasonal Flu vaccine."
"The accomplishments announced today further validate our strategy to create a rapid, in-border influenza vaccine solution for governments around the world by addressing gaps in currently available vaccine technologies," added Dr. Rahul Singhvi, President and CEO of Novavax, Inc.
Novavax, Inc has successfully completed a Phase I/IIa clinical study with a candidate H5N1 influenza VLP vaccine and is currently in Phase II trials with a VLP based seasonal flu vaccine candidate. The Company plans to initiate a Phase II study with its Seasonal Flu vaccine candidate in the elderly population during Q4, 2009.
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