Baxter International has completed production of its first commercial batches of Celvapan A/H1N1 pandemic vaccine and is discussing distribution plans with national health authorities, subject to obtaining authorizations. Celvapan is made using the company’s Vero cell culture technology. The company was able to produce the vaccine within 12 weeks of receiving the A/H1N1 virus strain.

Baxter plans to deliver initial quantities of the vaccine to national health authorities that have placed orders for the vaccine after the World Health Organization (WHO) declared a Phase 6 pandemic.

“We are pleased with our company’s ability to meet its expected timelines in developing and producing Celvapan,” said Joy Amundson, corporate vice president and president of Baxter BioScience. “This is an encouraging validation of our science, our Vero cell vaccine technology and the teamwork at Baxter in meeting this important milestone to help address an urgent public health issue.”

“To make Celvapan A/H1N1 vaccine, we applied the same development, qualification and manufacturing processes used in gaining EMEA licensure of a mock-up pandemic vaccine,” said Hartmut J. Ehrlich, M.D., vice president of global research and development for Baxter BioScience. “The mock-up vaccine made with a different pandemic strain was tested in five clinical trials worldwide in more than 1,300 people. In addition, more than 3,500 people have been vaccinated during an ongoing Phase III study.”

Confirmatory trials — to evaluate safety and immunogenicity of the vaccine in adults, the elderly and children — are scheduled to begin this month.

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