Baxter plans to present the initial results of the Phase I/II clinical trial October 11 at the World Vaccine Congress in Lyon, France, and October 20 during the Second International Conference on "Influenza Vaccines for the World" in Vienna, Austria, with final results available by the end of 2006.

The company also plans to begin a Phase III clinical trial of the candidate pandemic vaccine early next year and present final results by the end of 2007.


In addition to this Baxter funded Phase I/II clinical trial, the company is separately involved with the U.S. Government in other vero cell-based influenza vaccine development programs. Baxter is working with the U.S. National Institute of Allergy and Infectious Diseases, in partnership with Fisher BioServices Inc., and with the U.S. Department of Health and Human Services, in partnership with DVC LLC, a Computer Sciences Corporation Company, to further develop vero cell-based pandemic and seasonal influenza candidate vaccines. Both collaborations are the result of U.S. Government contract awards. Baxter and its partners will provide the vero cell-based candidate vaccines to the agencies for further clinical testing in the United States, which is expected to begin by the end of this year.

Baxter also is in discussions with a number of other governments regarding its proprietary vero cell-based candidate pandemic vaccine. Earlier this year, Baxter received a contract award to supply two million doses of cell-culture based candidate H5N1 vaccine to the U.K. Government.

Cell-based systems for production of vaccines offer a number of potential benefits over more traditional egg-based systems. Baxter's vero cell technology is capable of producing high yields of influenza virus without the addition of any animal-derived serum. Through the company's research and development work, Baxter has been successful in growing "wild-type" virus at pilot and commercial scales using its unique vero cell technology. This means the company is capable of manufacturing pandemic vaccine without the need to wait for high-growth or attenuated virus reassortants normally used when vaccine is produced in eggs.

Baxter is developing both seasonal (or inter-pandemic) and pandemic influenza vaccines based on the company's vero cell technology. Baxter has one of the largest existing cell-culture facilities in the world, capable of manufacturing large quantities of vaccine. Because the facility is engineered for BioSafety Level III production, the facility can utilize "wild type" pandemic strains to help accelerate production and reduce the total time required to produce vaccine by several weeks. Baxter's technology platform also allows it to implement rapid changes in strains that may be needed for new vaccine formulations.

More Industry Headlines