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Bird Flu Vaccine Ready to License

The biotechnology research firm, Novavax, announced impressive results in a human trial of the vaccine it is developing for the H5N1, or Indonesian, strain of bird flu discovered in 2005.  This particular strain of bird flu has made 385 people sick and killed 243 of them since 2003, according to the World Health Organization (WHO).

In recent years, the fear of global pandemic has centered around the spread of this bird flu, with the race to find a vaccine involving pharmaceutical giants GlaxoSmithKline, Novartis, and Sanofi-Aventis and government entities across the United States and Western Europe.

Novavax, too, has been in the race to find a vaccine and it seems the vaccine under current development has produced a 94% success rate, a rate of success that leads the company to begin the search for a financial partner to fund future trials.  The company, headquartered in Rockville, Maryland, has already partnered with GE Healthcare for development of production equipment that is inexpensive to install and operate in the event of pandemic.

The most recent Novavax trial involved 160 study participants who received two injected doses of vaccine, in strengths ranging from 15 micrograms (mcg) to 90 mcg, with the second injection following the first one by a month.

When antibodies were counted after complete inoculation, the group getting the most benefit from the vaccination were the people getting the highest dosages.  This group saw a 94% rate of neutralization of the flu virus in the bloodstream.

Using traditional methods of cultivation, growing enough flu virus to produce enough vaccine to protect against a pandemic outbreak takes the better part of a year.

Adding to the problem is the egg base in which the virus cultures are traditionally grown.  Egg-based culture media are chemically unstable and sometimes there are lapses in availability.  At this time, all flu vaccines made in the US come from egg-based cultures.

The Novavax vaccine is based on insect-cell cultures that are more stable than egg-based cultures.  The insect-based cultures grow the virus cultures faster, too, yielding enough to make vaccines in about 10 to 12 weeks, or about half the time of the more conventional, egg-based, cultures.

The biotech company is said to be searching for a financial partnership, either pharmaceutical or governmental, to fund the next stage of human trials, with the final goal of licensing the vaccine for production.

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