Japan to Promote Joint Clinical Trials of Domestic Vaccines with Asian Countries

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Kwon Jae-hee] The Japanese government is preparing a comprehensive plan to strengthen the vaccine development and production system.

According to the Asahi Shimbun on the 18th, the Japanese government’s vaccine "Task Force" (TF) is organizing a comprehensive plan that includes measures to accelerate vaccine development and is expected to report it to the Cabinet meeting soon. This TF is led by Izumi Hiroto, an advisor to the Prime Minister.

The core of this plan is a measure to conduct clinical trials investigating the efficacy and safety of newly developed Japanese vaccines together with various Asian countries.

Japanese experts cite the narrow clinical trial market as the main reason why Japan has fallen behind in the COVID-19 vaccine development race.

In the case of the United States or Europe, recruiting tens of thousands of patients needed for new drug clinical trials is relatively easy, but Japan finds it difficult to gather enough patients to conduct clinical trials independently.

It is especially known that securing clinical trial subjects becomes even more difficult for latecomers due to the lead effect of the frontrunners.

Considering this reality, the Japanese government has decided to organize a system led by the Japan Agency for Medical Research and Development (AMED) to cooperate with Asian countries and conduct joint clinical trials under unified standards.

The specific countries for cooperation have not been disclosed.

The Asahi Shimbun explained, "Joint clinical trials with Asian countries have been conducted in some drug development processes so far," and "this means they intend to put this into full-scale operation."

Joint clinical trials targeting Asians, who have similar ethnic backgrounds, are cited as advantageous because they allow easy verification of the characteristic effects and side effects of new drugs in the development stage.

The European Union (EU) is known to operate a system that enables joint clinical trials among member countries based on this background.

The comprehensive vaccine-related plan that Japan, which has yet to commercialize domestically developed vaccines, will present is also expected to include a proposal for the government to purchase completed vaccines to support the respective companies and to establish an organization responsible for vaccine stockpiling within the Ministry of Health, Labour and Welfare.

There is also consideration of introducing an "Emergency Use Authorization" (EUA) system that significantly simplifies the review process when data demonstrating the efficacy of newly developed vaccines is available.