THE ASAHI SHIMBUN
May 18, 2021 at 16:50 JST
The government plans to strengthen its system for jointly conducting domestic vaccine clinical trials with other Asian countries. (Asahi Shimbun file photo)
The central government is moving to accelerate the development of domestic vaccines against new infectious diseases, including the novel coronavirus, through close collaboration with other Asian countries on clinical trials, officials said.
Researchers study the efficacy and safety of new vaccines during clinical trials before they can be given to the general population.
Japan lagged behind other developed nations in coming up with a vaccine against COVID-19 due to difficulties in recruiting enough participants in Japan alone for large-scale clinical trials, according to officials.
Hiroto Izumi, a special adviser to the prime minister, leads the government task force for drawing up comprehensive measures to strengthen Japan’s vaccine development and production processes.
The Cabinet is expected to approve the new policy soon to speed up domestic vaccine development.
But it seems unlikely that domestic vaccines currently being developed could be put into practical use within the year. Large-scale clinical trials are currently proceeding with great difficulty.
Those clinical trials need to gather data on tens of thousands of participants before the health ministry can approve the vaccines for manufacture and sale.
The government plans to establish a new system that allows clinical trials to be conducted based on unified standards across Asian countries, led by the Japan Agency for Medical Research and Development.
Japan has been conducting trials jointly with other Asian countries on some drugs, but the new measure will bolster the system and allow them to become full-fledged clinical trials.
Researchers have said it is easier to study the distinctive effects or side effects of vaccines if participants are Asians with close ethnic similarities.
The European Union also allows EU members to jointly conduct clinical trials inside the bloc.
The government also plans to support pharmaceutical corporations by purchasing stocks of their developed vaccines and establish a new organization that will oversee the stockpiling of vaccines inside the health ministry.
The government is mulling establishing an Emergency Use Authorization (EUA) system, which would allow unapproved vaccines to be quickly deployed in emergencies if data shows they are effective.
In the United States, the Pfizer and Moderna COVID-19 vaccines became available through emergency use authorization.
If vaccines are reported to damage the health of recipients, such as through serious side effects, the focus of attention will then turn to how states or corporations should take responsibility.
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