Novavax Launches Pivotal Clinical Study of Novel 2009 H1N1 VLP Flu Vaccine in Mexico

23-Oct-2009 - Mexico

Novavax, Inc. announced that it has initiated a two-stage clinical study of its virus-like-particle (VLP) H1N1 influenza vaccine in Mexico in collaboration with Avimex laboratories (Avimex) and GE Healthcare. Avimex is providing financial support for the trial and is expected to distribute the H1N1 VLP vaccine in Mexico in 2010 if it is approved for commercial sale. In addition, Novavax also announced that GE Healthcare has agreed to support this program by providing its single-use bioprocessing technologies for vaccine production. GE Healthcare and Novavax have worked together since December 2007 to develop innovative vaccine production solutions using GE Healthcare's manufacturing technologies.

"This clinical study represents a unique opportunity to accelerate the development of our pandemic 2009 H1N1 flu VLP vaccine and address an important public health problem in Mexico. Conducting this clinical trial during a pandemic, when the attack rate of the H1N1 virus is expected to be very high, provides the company with an invaluable opportunity to demonstrate field efficacy of its VLP-based H1N1 vaccine and the utility of the VLP vaccine platform for influenza as a whole," said Dr.Rahul Singhvi, President and CEO of Novavax.

"Our new alliance with Avimex is another example of our regional strategy and will provide valuable assistance toward the successful completion of this important clinical study within a remarkably short horizon. The fast spread of H1N1 worldwide has caused a significant strain on vaccine supply in countries with limited indigenous vaccine capabilities. We are grateful to the Mexican health authorities for their rapid clinical protocol clearance and enabling our potential solution for this escalating unmet medical need," Dr. Singhvi added.

https://www.bionity.com/en/news/108396/novavax-launches-pivotal-clinical-study-of-novel-2009-h1n1-vlp-flu-vaccine-in-mexico.html