"The success of Novavax's 2009 H1N1 VLP pandemic influenza vaccine in the Mexico pivotal study clearly demonstrates the desirable tolerability and immunogenicity profile of our vaccine candidate in the largest clinical trial conducted by the Company to date.   We are highly encouraged by these results as the data meet the immunogenicity criteria of both the United States and European regulatory authorities.  These data enable potential emergency use of the vaccine in pandemic situations and could be supportive in other countries in addition to Mexico.  Based on these positive data, we have filed for regulatory approval of our H1N1 VLP pandemic influenza vaccine candidate in Mexico," said Dr. Rahul Singhvi, President and Chief Executive Officer of Novavax.  "The substantial safety dataset and strong immunogenicity signal from this large study provide us confidence as we plan Phase III studies of our seasonal trivalent influenza VLP vaccine, pending results from the ongoing Phase IIa trial in older volunteers and discussions with the U.S. Food and Drug Administration (FDA)."

Earlier this month, Novavax completed enrollment of a cohort of over 3,500 volunteers in Stage B of this pivotal study.  Over 2,500 of these volunteers received a single 15 mcg injection of Novavax's unadjuvanted 2009 A/H1N1 VLP pandemic influenza vaccine while 1,000 of the volunteers received a placebo.  The purpose of Stage B portion of this clinical study was to evaluate safety of the VLP vaccine.  

SOURCE Novavax, Inc.