Novavax Vaccine Effective Against Bird Flu

Novavax Inc. has developed a vaccine to immunize humans against the deadly Indonesian strain of bird flu, a disease that emerged in 2005 and has led to 110 deaths so far. The company has tested the vaccine during the course of a study and found the results positive.

In the study, 160 patients were given two injections each, in varying doses of 15 to 90 micrograms. 94 percent of patients on the highest dose of the vaccine developed immunity against the lethal H5N1 bird flu, Novavax stated in a statement released yesterday.

“These results are strong and very competitive,” said Rahul Singhvi, Novavax's chief executive.

“The data are encouraging that this new vaccine approach can help prevent pandemic influenza,” said Robert B. Belshe, an immunologist and infectious disease specialist at the Saint Louis University School of Medicine, who was on an independent safety monitoring board for the study.

Although no complete safety data for the study is currently available, no ‘serious’ side effects have been reported as yet, the company said.

Novavax, has been working with General Electric Co. to develop a vaccine that can be produced quickly and in large numbers. The companies intend to reach the rest of the world by providing other countries a system to quickly produce vaccines en-masse. GE has undertaken responsibility for cheap and viable production equipment.

Analyst Ken Trbovich, with RBC Capital Markets, said, “The technology may be good, but it doesn't mean they will prevail in winning a large government contract. Most of the contracts over the last two years have occurred with very large, established players in the vaccine field.”

Many large multinational biotech companies – GlaxoSmithKline, Sanofi-Aventis, Novartis – are also engaged in developing vaccines to rein in a possible flu pandemic in the United States and Western Europe under government contract, according to Trbovich.

Traditionally, flu vaccines were developed by introducing live virus strains in chicken eggs, which act as incubators. The virus is later bottled into a vaccine.

Novavax's bird flu vaccine eschews this process and uses particles that mimic the size and shape of the virus, instead. Because the particles are produced in insect-cell cultures that are more stable, the yields are seven to 10 times higher than egg-based manufacturing, Novavax claimed. The vaccine can also be created within 10 to 12 weeks of identifying a pandemic strain, which is only about half the time needed to make egg-based vaccines.

Novavax is looking for a governmental or pharmaceutical partner to finance the next set of human trials. "We see no reason to invest additional money of our own into the pandemic vaccine when we can wait for a foreign government that needs this vaccine to put money in," Singhvi said.

Meanwhile, Novavax will begin human trials of its seasonal influenza vaccine in the fall.