CDC TO EVALUATE NOVAVAX'S PANDEMIC INFLUENZA VACCINE CANDIDATE
First Opportunity To Test Novel Vaccine Against Live Virus
MALVERN, Pa., Oct. 31 /PRNewswire-FirstCall/ -- (Nasdaq: NVAX) - Novavax, Inc. said today the U.S. Centers for Disease Control and Prevention (CDC) has agreed to evaluate the company's H5N1 pandemic influenza vaccine candidate, including pre-clinical testing of the vaccine against live bird flu virus.
"We are pleased that the government has agreed to test the protective efficacy of our vaccine candidate," said Dr. Rick Bright, Novavax's Vice President of Global Influenza Programs. "The CDC, one of a handful of premier infectious disease institutions, has the unique ability to challenge our vaccine with live avian influenza virus."
Under terms of a Cooperative Research Agreement, Novavax will provide the CDC with a supply of the company's virus-like particle (VLP) H5N1 vaccine. Over the past year, Novavax has assembled a significant dossier of pre-clinical data supporting its vaccine which will serve as the basis for the company's investigational new drug application to the U.S. Food and Drug Administration. Novavax is planning to begin human clinical trials using the vaccine during the first half of 2007.
"It is absolutely critical that we are prepared for a potential outbreak of pandemic influenza," said Dr. Terrence Tumpey, Senior Microbiologist at the CDC. "Vaccines like these hold a lot of promise because they offer an attractive alternative to the existing egg-dependent methods for the manufacture of influenza vaccine and have a shorter production lead time which is urgently needed at this time."
Last year, Novavax began collaborating with the CDC to evaluate a vaccine to protect against the H9N2, another subtype of bird flu. "This working relationship further validates the importance of our influenza program and underscores the confidence we have in our influenza VLP vaccine," Dr. Bright said.
VLPs are nearly identical to a virus but do not have the virus's genetic material required for replication or infection. When inoculated into the body, these particles have the ability to attach to cells and trigger a natural immune response that is capable of protecting against viral infection.
Novavax, Inc. is committed to leading the global fight against infectious disease by creating novel, highly potent vaccines that are safer and more effective than current preventive options. Using the company's proprietary virus-like particle (VLP) and Novasome(R) adjuvant technologies, Novavax is developing vaccines to protect against H5N1 pandemic influenza, seasonal flu and other viral diseases. Novavax's particulate vaccines closely match disease-causing viruses while lacking the genetic material to cause disease, which provides potential for greater immune protection at lower doses than current vaccines. With an exclusive portable manufacturing system that allows for rapid mass-production of vaccines, Novavax is uniquely positioned to meet global public health needs.
SOURCE Novavax, Inc.
CONTACT: Mariann Caprino, +1-484-913-1213,
for Novavax, Inc.