Baxter Completes Production of First Commercial Batches of A/H1N1 Pandemic Vaccine

Baxter International, Inc. (Deerfield, IL) has completed production of its first commercial batches of Celvapan A/H1N1 pandemic vaccine in late July and is discussing plans for distribution with national health authorities, subject to obtaining appropriate authorizations. Celvapan, the brand name for the company's A/H1N1 pandemic influenza vaccine, is made using Baxter's proprietary Vero cell culture technology.

Baxter plans to deliver initial quantities of Celvapan to national public health authorities that have pandemic agreements with the company. These health authorities placed orders for the vaccine following the World Health Organization’s elevation of the pandemic alert level to Phase 6 and declaration of a pandemic.

Baxter's proprietary Vero cell production technology is meeting the company's expectations to rapidly produce a vaccine in response to a pandemic. Celvapan was developed and commercially produced using this process within 12 weeks of receiving the A/H1N1 virus strain.

Baxter is collaborating with regulatory authorities to ensure the company is in accordance with all requirements needed to support approval and use of Celvapan.

Confirmatory clinical trials to evaluate safety and immunogenicity of Celvapan A/H1N1 in adults, the elderly, and children are scheduled to begin in August. Baxter has initiated its license application for Celvapan A/H1N1 based on the EMEA published guidelines for pandemic vaccine marketing authorization and will supplement its application post approval with the appropriate safety and immunogenicity data from the confirmatory clinical trials. After national vaccination programs are initiated, Baxter also will conduct a large-scale observational study in people receiving Celvapan. In all countries, decisions to administer the vaccine will be determined by local public health authorities.