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Novavax Claims, Its New Bird Flu Vaccine Is Promising

Novavax Inc. said a new type of bird flu vaccine using a mock version of the virus is safe for testing. The results of the human safety trials conducted by the Rockville, Maryland-based biotech company appeared to be promising against the H5N1 A/Indonesia/05/2005 avian influenza strain.

This strain was first seen in humans in 2005 in Indonesia and has resulted in 135 human cases, 81 % of which were fatal.

Novavax President and Chief Executive Officer Dr. Rahul Singhvi told investors in a conference call, “These results are strong and very competitive and they compare well with any vaccine against pandemic flu, whether licensed or in development.”

Most vaccines use either a live but weakened flu virus or a killed virus to stimulate the immune system. The vaccines have to be reformulated every year to keep pace with the constantly mutating and changing flu strains. This process can takes months as specially grown live chicken eggs are used. Novavax uses a process the company feels will be quicker than the current method employed by growing the vaccine in lab dishes of caterpillar cells and using a decoy of the virus. “It looks like the virus in that it has the same size and shape as the virus,” Singhvi said. “It is not a virus but the body views it as a virus,” he said as it does not have the genes though to replicate itself.

Though the avian virus rarely strikes humans, it has killed 243 out of the 385 people infected since 2003 and experts worry it could mutate into a more infectious and dangerous form. Currently the H5N1 avian influenza virus is affecting poultry in Asia, Europe, the Middle East and Africa. Several companies are working at making a vaccine that could protect against H5N1 and Novavax is developing the avian flu vaccines with GE Healthcare, a division of General Electric. The company said the highest dose of the vaccine stimulated a protective level of antibodies in 94% of the people who were vaccinated.

Dr. Robert Belshe of the Saint Louis University School of Medicine in Missouri, who served on the Data and Safety Monitoring Board for the study, said in a statement, “Two doses of this novel vaccine — which is designed to prevent bird flu — gave strong immune responses. The data are encouraging that this new vaccine approach can help prevent pandemic influenza.”

Novavax’s chief medical officer Dr. Penny Heaton said, “We will proceed with clinical development when we have a partner.”

The company plans to begin testing a seasonal flu vaccine later this year and has said it would submit its findings for review. They are also working on trying to avoid potentials of human disasters by using quick and inexpensive deployment in outbreak prone areas where the vaccine could be developed in as little as three months time. Dr. Singhvi said, “These results are strong and very competitive and they compare well with any vaccine against pandemic flu, whether licensed or in development.”

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