GSK K.K. plans to file an application with the health, Labor and Welfare Ministry possibly next year, for the vaccine’s adoption for the government’s stockpiling program.
Currently, all prepandemic vaccines stockpiled by the government are domestically developed. GSK’s vaccine would be the first foreign-made one to be stockpiled in Japan if approved.
The government has stored prepandemic flu vaccines for a bout 20 million people and plans to add vaccines for another 10 million.
Like domestically produced vaccines GSK’s vaccines was made from the H5N1 strain of bird flu virus, which has been spreading in Asia. But its vaccine has a unique immunity enhancing agent, GSK said.
The vaccine uses only a small amount of antigens, the company said, adding it has proved effective against viruses in other countries.
The European Union has already approved GSK’s vaccine, prompting some of its 27 member countries to stockpile it as a prepandemic vaccine.
The health ministry decided Wednesday to designate the vaccine as a pharmaceutical product for rare diseases, which are eligible for priority screening for government approval and development subsidies.
Source: Japan Times, August 29, 2008