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British drug maker to start clinical trial of COVID-19 vaccine in Japan 

  • July 18, 2020
  • , Mainichi, Yomiuri, Nikkei
  • JMH Summary

Saturday’s Mainichi reported that UK pharmaceutical manufacturer AstraZeneca has decided to conduct in Japan in August a clinical test of a coronavirus vaccine that it is developing jointly with the University of Oxford. The company may also establish an assembly line to manufacture the vaccine in Japan. Although AstraZeneca plans to conduct the first part of a three-stage trial designed to verify the vaccine’s safety and effectiveness in Japan, the final part covering a large number of subjects probably will not take place here because of the relatively low infection rate. As such, AstraZeneca is likely to seek approval for the vaccine’s use in Japan under the Health Ministry’s “exceptional approval” system, for which the results of the final phase of a trial conducted abroad can substitute for one conducted domestically. 

 

Meanwhile, Saturday’s Yomiuri wrote from New York that Johnson & Johnson is likely to launch the final phase of its COVID-19 vaccine clinical test in the U.S. in late September and that the U.S. drug company is holding talks with the Japanese government on possibly providing the vaccine in Japan.  

 

In a related story, Saturday’s Nikkei wrote that Fujifilm plans to start a clinical test involving 1,000 participants of its flu drug Avigan for COVID-19 treatment in Kuwait in late July. As Avigan’s clinical trials are running into difficulties in Japan because of a dearth of subjects, the company is hoping that if the results of the Kuwait trial prove to be promising, the flu drug can be approved for use in Japan under the “exceptional approval” system.  

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