GSK Releases Flu Vaccine Production Strategies

GlaxoSmithKline (Uxbridge, UK) is actively pursuing several strategies for meeting worldwide demand for the development, manufacture, and accessibility of flu vaccines.

As announced in the company’s second-quarter report and a vaccines seminar in June, the company is taking steps to boost its existing Fluarix flu vaccine production capacity as well as continuing trials of an “improved” flu vaccine formulation, developing a new cell culture-based production system (for projected introduction in 2010), and preparing for a possible flu pandemic.

During the seminar, Bruce Innis, MD, GSK’s vice-president of Clinical Research and Development and Medical Affairs for Vaccines for Virus Diseases, said the company plans to expand the company’s Dresden, Germany facility to manufacture 35 million doses of Fluarix for the 2005–2006 season—up 5 million from 2004. Long-term plans include more than doubling Fluarix production to 80 million doses in the next three years.

The company estimates a worldwide flu vaccine manufacturing capacity of 300 million doses for the 2005 season, of which 51% are attributed to Sanofi Aventis, 25% to Chiron (assuming it manages to operate at full capacity), and 11% to GSK. These numbers will most likely shift, however, as Chiron (Emeryville, CA) prepares to respond to the list of Form 483 observations it received on July 21 following FDA inspection of its Liverpool facility, which produces the company’s Fluvirin vaccine.

During his presentation, Innis also revealed clinical safety and immunogenic data from completed Phase I and II studies conducted for an “improved” flu vaccine formulation. The drug combines flu antigens and a “novel adjuvant” to enhance T-cell responses to the flu virus. Results of the studies conducted on elderly clinical trial subjects showed “improvements in T-cell responses are being achieved.”

The company also briefly outlined the company’s preparation plans for a possible flu pandemic, including technology that would allow for “surge” production and stockpiling.

–Maribel Rios