May 11 , 2021. 20 hours ago – 13:30 KYODO NEWS
TOKYO – Prime Minister Yoshihide Suga said Monday the government needs to speed up the process of approving clinical trials of COVID-19 vaccines at a time when Japanese drugmakers have lost ground to foreign rivals.
“We need to consider revising the system, to approve (trials) more quickly,” Suga said at a House of Representatives Budget Committee meeting.
In Japan, Shionogi & Co. and several other companies have been developing coronavirus vaccines, but large-scale clinical studies have been a major hurdle to getting domestic vaccines approved and on the market.
In order to gain approval, a vaccine needs to pass a clinical study involving tens of thousands of participants in which its safety and efficacy is assessed, but due to the relatively low number of community coronavirus infections in Japan, the effectiveness of the vaccines is difficult to evaluate.
In addition, inoculation programs using vaccines developed by U.S. and European companies are already under way in Japan and elsewhere, reducing demand.
As more people gain resilience against the virus with the progress of the vaccination programs and the spread of infections, it is expected to become increasingly difficult to recruit a sufficient number of test subjects who hold no immunity.
Cr. KYODO NEWS