Baxter’s Preflucel seasonal flu vaccine has been approved in 13 European countries via the repeat mutual recognition procedure (rMRP). Austria, which approved the vaccine back in September 2010, acted as the reference state for clearance of the drug via the rMRP pathway. Baxter says the latest countries in which the drug is now approved, including Germany, Spain, the U.K., and Nordic countries, will implement the license in order to make Preflucel available for the 2011-12 flu season.
Preflucel comprises purified, inactivated split influenza virions, and is manufactured using Baxter’s mammalian cell line-based Vero cell platform. Data from a U.S. Phase III study in over 7,200 healthy individuals has shown Preflucel provided 78.5% protective efficacy against subsequent culture-confirmed influenza infection, and robust immune responses against the three viral strains contained in the vaccine. Data from this study was published in The Lancet in mid-February.
In December 2010 Baxter and Takeda Pharmaceutical inked a development, license, and technology transfer agreement that essentially expands their previous collaboration to develop Vero cell culture-based flu vaccines for the Japanese market. Under terms of the new deal the companies are jointly developing an H5N1 flu vaccine, and Takeda is pursuing Japanese government funding for the construction of a Vero cell-based flu manufacturing facility in Japan.