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. Once national vaccination programs are initiated, Baxter will also 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.

Baxter received the A/H1N1 strain for testing and evaluation from the U.S. Centers for Disease Control and Prevention (a WHO Collaborating Center) in early May. The company then undertook pre-production testing and evaluation of the virus strain to assess its growth characteristics and ability to work in the company’s proprietary Vero cell culture. Based on the virus’ ability to grow in Vero cell culture, Baxter initiated commercial production on June 3, 2009. Bulk CELVAPAN vaccine is produced at its large-scale commercial facility in Bohumil, Czech Republic, and is sent to Vienna, Austria for the final formulation, fill and finish before distribution.

Mock-up licensure is a regulatory pathway for pandemic vaccines that was created by the European Medicines Agency (EMEA) in 2004. This pathway allows for the development, evaluation and testing of a company’s vaccine production capabilities using an available influenza strain that has the potential to cause a pandemic. Once a pandemic is declared and the influenza virus strain causing the pandemic is identified, the mock-up licensure allows for fast track approval of a pandemic vaccine containing the actual pandemic strain. Other countries may choose to evaluate the company’s EMEA submission and use that information as the basis for their national health authority’s authorization for use of the vaccine.