Daiichi Sankyo Fails to Meet Goal for H5N1 Vaccine in Japan

By Pharma News - DCAT Publisher

March 11, 2014

Daiichi Sankyo Company Limited reported on March 8, 2014 that Kitasato Daiichi Sankyo Vaccine Company Limited will not be able to meet development and production capacity goals to supply H5N1 vaccines by the end of March 2014 as had been arranged under a grant by the Japanese Ministry of Health, Labour and Welfare that was announced in August 2011. Daiichi was selected under a cell-culture vaccine-production facility capacity-building grant, which is a part of the Ministry's second initiative for H5N1 vaccine. Kitasato Daiichi Sankyo Vaccine was preparing to build a system to supply vaccines by the end of March 2014.

"After process validation of production at the actual plants, Kitasato Daiichi Sankyo Vaccine recognized in October 2013 that vaccine yields would decline during the purification process. The company considered countermeasures to improve the situation, but it was deemed impossible to achieve the original goal of creating a scheme by March 31, 2014 to supply vaccines for 40 million people in six months," said the company in a statement. The company reported this and offered countermeasures to the Health Ministry's Initiative to Build Development and Production Capacity for H5N1 Influenza Vaccines Assessment Committee.

In the original scheme using a 30-μg/mL formulation, the company had anticipated producing vaccine antigen yields necessary for providing vaccine to 40 million people in six months by using existing plants of vaccine bulk production. However, in the two purifying processes, the zonal ultra-centrifugation process and final filtering process, the vaccine antigen yields  dropped significantly resulting in a process that would only produce vaccine for approximately 20 million people at the final formulation.

"Daiichi Sankyo and Kitasato Daiichi Sankyo Vaccine sincerely apologize for being unable to achieve the originally planned scheme in the timeframe allotted," said the company in a statement. "Daiichi Sankyo and Kitasato Daiichi Sankyo Vaccine will take the post-evaluation results of the Assessment Committee in earnest and make efforts throughout the company to faithfully carry out the mission," said the company in its statement.

Daiichi Sankyo