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Wednesday, 09/20/2006 7:05:32 AM

Wednesday, September 20, 2006 7:05:32 AM

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Novavax Initiates Pre-Clinical Testing of Intranasal Influenza Vaccine
Tuesday September 19, 7:00 am ET
New Delivery Route May Provide Alternative to Administration by Injection

MALVERN, Penn., Sept. 19 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX - News) said today that it has begun pre-clinical testing of intranasal versions of its influenza vaccines in development, providing a potential alternative to administering these vaccines by injection.


"This is an important advancement for our existing technology because it will allow us to reach an even broader population," said Dr. Rick Bright, Novavax's Vice President of Vaccine Development. "There are many parts of the world that do not have accessibility to enough sterile needles to respond to an influenza crisis."

Historically influenza vaccines have been administered though intramuscular injection. However, the World Health Organization (WHO) has been proactively seeking alternative delivery methods. "The problem with needles is that conditions must be highly sterile in order to prevent contamination during the mass vaccination that would take place in the event of an emergency," Dr. Bright said.

Novavax is investigating the intranasal delivery route using both the company's seasonal and pandemic virus-like particle (VLP) vaccines in pre-clinical models. "Our early data indicate that we can trigger a protective immune response with the intranasal vaccine that is as robust as our intramuscular formulation," Dr. Bright said. "We are eager to further explore this route of delivery in additional pre-clinical work as well as human studies."

Using the company's proprietary VLP technology, Novavax scientists create a particle that is nearly identical to a virus but does 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 scientists are using the Clade 2 H5N1 influenza virus -- for both the intranasal and intramuscular versions of its pandemic influenza vaccine. The Clade 2 variant, identified in birds from China and Indonesia before spreading to Europe, the Middle East and Africa, is primarily responsible for human infections and mortality over the last year. The WHO recently changed its H5N1 avian influenza guidance to indicate that pandemic vaccine candidates should target viruses from the Clade 2 family rather than the earlier Clade 1 family.

"By creating our vaccines against the Clade 2 strain of pandemic influenza, we are targeting protection against the most current form of this deadly H5N1 virus," Dr. Bright said.

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