Baxter completes first swine flu vaccine batches
US healthcare company Baxter International has completed its first commercial batches of A/H1N1 vaccine.
US healthcare company Baxter International has completed its first commercial batches of A/H1N1 vaccine.
The Deerfield-based company says it will begin clinical trials this month and is discussing distribution plans with national health authorities, subject to achieving appropriate authorisations.
The swine flu vaccine, to be sold under the Celvapan brand, is made using Baxter's proprietary Vero cell culture technology, instead of the typical method using chicken eggs.
The company says Celvapan was developed and commercially produced using its Vero process within 12 weeks of receiving the A/H1N1 virus strain from the US Centers for Disease Control and Prevention.
"The "mock-up" vaccine made with a different pandemic strain was tested in five clinical trials worldwide in more than 1,300 people," said Hartmut Ehrlich, vice president of global research and development for Baxter BioScience.
The European Medicines Agency (EMEA) has approved this mock-up vaccine.
Confirmatory clinical trials to evaluate safety and immunogenicity of Celvapan in adults, the elderly and children are scheduled to begin this month.
Bulk Celvapan vaccine is produced at Baxter's facility in Bohumil, Czech Republic, and sent to Vienna, Austria for the final formulation, fill and finish before distribution.
The company has orders for 80 million doses of the swine flu vaccine with five countries, but not the US.
"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."
