Bio-Tech

US FDA Licenses New Influenza Vaccine Manufacturing Facility

Sanofi Pasteur, the vaccines division of Sanofi-Aventis Group, recently announced that the US Food and Drug Administration (FDA) has licensed its new influenza vaccine manufacturing facility. This new facility in Swiftwater, Pennsylvania, will incorporate the latest technology in egg-based vaccine production as part of the company's commitment to produce the largest number of doses of vaccine in the shortest time to address the threat of seasonal and pandemic influenza.

The licensure of this facility is for production of the company's seasonal trivalent influenza vaccine, Fluzone, Influenza Virus Vaccine, and augments the current Fluzone vaccine production capacity in the US. Fluzone vaccine is given for active immunisation in persons six months of age and older against influenza virus types A and B contained in the vaccine.

Sanofi Pasteur invested in the construction of this new $150 million, 140,000 square-foot (13,000 square-meter) vaccine facility as part of its commitment to support public health and to protect individuals against both seasonal and pandemic influenza. The new facility will produce 100 million doses when operating at full capacity.

In total, Sanofi Pasteur will have a capacity of approximately 150 million doses of trivalent seasonal influenza vaccine per year in the US — 50 million doses from the existing facility and 100 million doses from the new facility. Production of Fluzone vaccine for the 2009-2010 season is already underway in the new facility.

"Sanofi Pasteur is assessing its capabilities to support public health efforts should the WHO and national health authorities request that influenza vaccine manufacturers start supplying vaccine to protect against the new influenza A (H1N1) virus," said Wayne Pisano, President and CEO, Sanofi Pasteur. "With the licensure of this new influenza vaccine production facility, we now have additional flexibility to produce seasonal influenza vaccine and to respond to requests from public health authorities to develop an A (H1N1) vaccine," he added.

EH News Bureau