FDA approves new seasonal influenza vaccine
Flucevax is produced using virus strains grown in mammal cells, as opposed to more common methods that use fertilized chicken eggs. Although other U.S. licensed vaccines use cell-culture technology, Flucevax is the first flu vaccine to utilize the method.
"Today's approval represents the culmination of efforts to develop a seasonal influenza vaccine using cell culture as an alternative to the egg-based process," Dr. Karen Midthun, the director of the FDA's Center for Biologics Evaluation and Research, said.
Cell-culture technology holds several key advantages over the egg-based process, including the ability to maintain an adequate supply of previously tested and characterized cells for use in production when needed, as in the case in a pandemic.
"The approval of Flucelvax is an important milestone for our influenza franchise and brings an innovative vaccine to the U.S.," Novartis Vaccines and Diagnostics Division Head Andrin Oswald said, Reuters reports. "Modern cell-culture technology will likely become the new standard for influenza vaccine production and we are proud to lead the way."
Novartis partnered with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority to develop the technology needed to produce Flucevax. Total investment on the project, including the construction of a production facility in North Carolina, exceeded $1 billion, Reuters reports.