Novavax achieves milestone in novel H1N1 influenza vaccine
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,
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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