German regulatory authorities approved Celtura®, Novartis’ cell culture-based monovalent vaccine against pandemic influenza A (H1N1). The MF59® adjuvanted, inactivated flu virus vaccine is indicated for active immunization of adults and children over the age of six months.
Novartis confirmed that it is also pursuing Celtura registration in other major countries including Japan and Switzerland. The cell-culture technology used to produce the viral antigen components was previously licensed in Europe for the production of its seasonal flu vaccine, Optaflu®.
“Our modern cell culture technology can enable a faster start-up of vaccine manufacturing, offering the ability to respond more quickly to future pandemic threats,” states Andrin Oswald, CEO of Novartis Vaccines and Diagnostics. “We quickly ramped up capacity at our licensed cell culture facility in Marburg, Germany, to respond to the need for pandemic vaccine.”
Novartis says that it is also close to completing its second cell culture-based influenza manufacturing site in the U.S., which is being constructed in partnership with the U.S. Department of Health and Human Services.
Novartis’ egg-based pandemic vaccine, Fluvirin® A (H1N1) was approved by the FDA in mid September. Additionally, Focetria® A (H1N1), an egg-based monovalent vaccine, was approved in Europe by the EMEA during late September. Both vaccines have already started shipping.