Takeda Pharmaceutical Company (Japan) recently announced they have received a 23.9 billion yen subsidy from the Japanese government to develop the production capability for new influenza vaccines. Last year, Takeda and Baxter entered into a license agreement for Baxter’s proprietary Vero cell culture based influenza vaccine technology. Baxter is one of the few companies in the world with a cell culture produced influenza vaccine.
Takeda plans begin shipments of vaccine in 2014 and will initially develop a vaccine to immunize against H5N1 avian flu. Takeda is expected to build capacity to produce sufficient vaccine for at least 40 million people
Takeda will set up a new facility at its Hikari plant and use Baxter’s Vero cell production technology to produce vaccines faster than conventional methods that rely on chicken eggs. Takeda and other major Japanese drug makers pulled out of flu vaccine production in the mid-1990’s after a legal change made immunizations voluntary. The legal challenge reduced demand for the vaccine.
The Vero cell line is a continuous cell line and has been in use for decades to produce Polio vaccine in the United States. Thus, the Vero cell line has a history of safety and regulatory acceptance. Cell based influenza production using Vero or MDCK cells has been gaining acceptance in Europe and other parts of the world. However, an influenza vaccine using cell based production has not yet been approved by the United States Food and Drug Administration (FDA). Approximately 160 million doses of influenza vaccine are produced for the United States market each year. The Production of US influenza vaccines rely on traditional egg based production that is considered slower and more limited in scale than newer cell based technology.