ROCKVILLE, Md., Feb. 18, 2011 /PRNewswire/ — Novavax,
Inc. (Nasdaq: NVAX) a clinical-stage biopharmaceutical
company, today presented the final safety and immunogenicity
results from its 2009 H1N1 virus-like particle (VLP) pandemic
influenza vaccine clinical trial in Mexico at the invitation-only
7th World Health Organization Meeting (WHO) on Evaluation of
Pandemic Influenza Vaccines in Clinical Trials. The meeting was
held at the WHO headquarters in Geneva, Switzerland where Dr.
Gregory Glenn, Chief Medical Officer of Novavax, presented the
findings at a session entitled: “Pandemic and Potentially Pandemic
Vaccines Developed Using New Technologies.” Dr. Glenn’s
presentation was entitled: “Phase II randomized, double-blind,
placebo-controlled trial of a novel (H1N1) influenza VLP vaccine”
and is available at www.novavax.com under the
In this randomized, double-blind, placebo-controlled Phase II
trial, Novavax’s H1N1 VLP vaccine was administered in a single-dose
regimen to over 3,000 subjects. The study found that the vaccine
exceeded the immunogenicity criteria for seasonal influenza vaccine
licensure at all dose levels including the 5mcg dose. Additionally,
a single administration of the VLP vaccine induced high levels of
hemaglutinin inhibition (HAI) titers in subjects without
pre-existing detectable immunity to this pandemic influenza strain.
Together, the data indicate that the H1N1 VLP vaccine was
well-tolerated and immunogenic.
Dr. Glenn commented: “This trial was an important
milestone for our influenza vaccine program and demonstrated the
potential of our recombinant vaccine technology. The data
indicate that our VLP vaccine was well-tolerated and generated
robust immunogenicity at all dose levels, including the 5mcg dose.
The single-dose seroprotection data in patients who had no
pre-existing immunity (seronegatives) achieved protective titers in