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The New England Journal of Medicine Publishes Study Investigating the Safety and Efficacy of Baxter's Cell-Based Pandemic, Avian Flu Vaccine
Date:6/11/2008

Statistically, the non- adjuvanted formulations induced the highest rates of subjects with a titer (antibody concentration in the blood) more than 1:20 after the first (40.5 percent and 39.5 percent for 7.5 micrograms and 15 micrograms) and second (76.2 percent and 70.7 percent for 7.5 micrograms and 15 micrograms) vaccinations, demonstrating this vaccine generates a robust immune response.

Regarding seroconversion (development of antibodies) or the percent of subjects demonstrating a more than four-fold increase in titer after immunization, the highest responses were again seen with the 7.5 micrograms and 15 micrograms non-adjuvanted formulations, with 69.0 percent and 68.3 percent seroconversion, respectively.

High levels of cross-reactivity were demonstrated against the A/Hong Kong strain with the 7.5 micrograms and 15 micrograms non-adjuvanted formulations (76.2 percent and 78.0 percent, respectively, with neutralizing titer more than 1:20). The responses against the clade 2 strain were somewhat lower (45.2 percent and 36.6 percent with NT titers greater than or equal to 1:20 for the 7.5 micrograms and 15 micrograms non-adjuvanted formulations, respectively). This demonstrates the ability of the vaccine to induce cross-reactive immune responses against divergent H5N1 strains.

The most common side effects were injection site reactions, headaches and fatigue, and the most common local reaction was pain at the injection site.

Baxter's Pre-Pandemic Planning Efforts

Baxter works closely with governments worldwide on pandemic preparation. The company has delivered several million doses of CELVAPAN to various governments around the world. In 2006, Baxter entered into a pandemic preparedness contract with the Austrian Ministry of Health to supply 16 million doses of pandemic influenza vaccine in the event a pandemic is declared. The company also delivered a stockpile of two million doses of CELVAPAN to the U.K. Department of Health as
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SOURCE Baxter International Inc.
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