Baxter plans to deliver initial quantities of the vaccine 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 (WHO) 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. Baxter’s vaccine was developed and commercially produced using this process within 12 weeks of receiving the A/H1N1 virus strain, which represents an innovation in vaccine production.
Baxter is collaborating with regulatory authorities to ensure the company is in accordance with all requirements needed to support approval and use of vaccine. “To make A/H1N1 vaccine, we applied the same development, qualification and manufacturing processes used in gaining European Medicines Agency (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 clinical trials to evaluate safety and immunogenicity of A/H1N1 vaccine in adults, the elderly and children are scheduled to begin in August. Baxter has initiated its license application for A/H1N1 vaccine 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. Once national vaccination programs are initiated, Baxter will also conduct a large-scale observational study in people receiving vaccine. In all countries, decisions to administer the vaccine will be determined by local public health authorities.
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