Baxter Completes Production Of First Commercial Batches Of Celvapan

Baxter has completed production of its first commercial batches of celvapan A/H1N1 pandemic vaccine, and is discussing plans for distribution with national health authorities.

Baxter plans to deliver initial quantities of celvapan to national public health authorities that have pandemic agreements with the company. The company is collaborating with regulatory authorities to ensure it is in accordance with all requirements needed to support approval and use of celvapan.

Moreover, the company has initiated its license application for celvapan A/H1N1 based on the EMEA published guidelines for pandemic vaccine marketing authorization. Baxter will supplement its application post-approval with the appropriate safety and immunogenicity data from the confirmatory clinical trials.

Hartmut Ehrlich, vice president of global research and development for Baxter, said: “To make celvapan 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. 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.”