BARDA Hails FDA's Approval of Flu Vaccine Manufacturing
The first approval to manufacture seasonal influenza vaccine using cell-based technology in a U.S. facility "demonstrates the effectiveness of a multi-use approach to emergency preparedness," Director Robin Robinson, Ph.D., noted June 17.
Calling it a milestone event in the nation's readiness to combat seasonal or pandemic influenza, Biomedical Advanced Research and Development Authority (BARDA) Director and Deputy Assistant Secretary for Preparedness and Response Robin Robinson, Ph.D., praised the U.S. Food and Drug Administration's first approval for manufacturing seasonal influenza vaccine using cell-based technology in a U.S. facility. The facility is owned by Novartis of Basel, Switzerland, and located in Holly Springs, N.C., and the approval means it can manufacture cell-based vaccine against seasonal and pandemic influenza viruses. "This new capability demonstrates the effectiveness of a multi-use approach to emergency preparedness," Robinson wrote.
BARDA sponsors the development of new technologies for use in emergencies, including the cell-based technology used at Holly Springs. The facility was built through a partnership established in 2009 between BARDA and Novartis to increase the domestic production capacity of pandemic flu vaccine and quickly provide additional influenza vaccines to combat public health threats.
According to BARDA, the Holly Springs facility can produce up to 200 million doses of pandemic influenza vaccine within six months of the declaration of a pandemic.