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Baxter International, Inc. (NYSE: BAX) has officially announced the completion of phase I/II testing for its adjuvant-free investigational pandemic H5N1 influenza vaccine. Having finished Phases I and II, they are ready to begin Phase III, which entails testing their vaccine on the general public to insure the safety and efficacy of this vaccine.
Baxter’s Bird Flu vaccine has proven very effective in Phase I and II studies already, and it shows promise as the only vaccine that fights multiple strains of influenza, as opposed to the seasonal flu vaccines we are used to. This means that the vaccine can be used as a preventative agent rather than a treatment.
Baxter’s new influenza vaccine is one of the only vaccines to use the Vero cell-based system. This means that the vaccine will not be using an adjuvant to stimulate the body’s immune system. Instead, the vaccine is effective enough on its own, even in small doses, to prevent influenza without additional stimulants. So far the vaccine tested with a 76.2 success rate of neutralizing antibodies by day 42, and this is without an adjuvant.
According to Dr. Hartmut Ehrlich, vice president of Global Research and Development for Baxter's BioScience business, “These preliminary results suggest that the vaccine produces a highly immunogenic vaccine with a favorable safety profile without the need for an adjuvant to boost the immune response. Adjuvant can add considerable cost and may have a negative effect on tolerability.”
According to the company, getting the vaccine to the public faster and more cost efficiently means that we will all be better prepared should the government announce a pandemic.
Already, Baxter has begun shipping their vaccine across the world to begin Phase III testing. Having these vaccines world wide means that the vaccine is effective for more than a single strain of influenza, so it will stay effective for more than one year at a time. Baxter intends to finish up Phase III testing of their vaccine later this year, and results should be published by the end of 2007.
About Baxter International
Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other conditions. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients' lives.
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