JICA to Build Overseas Clinical Trial Network for Japan-Made Vaccines

Yomiuri Shimbun file photo
A resident receives her fourth COVID-19 vaccination in Tokyo last May.

The Japan International Cooperation Agency has launched joint efforts with domestic pharmaceutical companies to establish an overseas clinical trial network for Japan-made vaccines. The idea is to heighten preparations for pandemics involving new infectious diseases, according to sources.

The envisaged network will cover six countries, from Kenya to Thailand. JICA intends to develop readiness for a new pandemic by conducting training for medical personnel and promoting technical cooperation to enable clinical trials of Japan-made vaccines.

While Western companies commercialized vaccines against COVID-19 swiftly, Japanese companies lagged far behind in the development of such vaccines. One main reason was that Japanese companies could not conduct the final stage of clinical trials, which requires inoculation of 30,000 to 40,000 people, as they had difficulty securing enough participants.

By the time the Japanese firms obtained cooperation from people in foreign countries, COVID-19 vaccination had already progressed worldwide, making it difficult to confirm the effectiveness of their vaccines.

Learning from this lesson, JICA is preparing a clinical trial network involving India, Indonesia, Kenya, the Philippines, Thailand and Vietnam. These countries were selected based on JICA’s past assistance there, such as the establishment of medical research institutes and provision of technical support.

In case an outbreak of a new infectious disease occurs, vaccines being developed by Japanese companies will be administered to patients in these six countries so that clinical trials can be conducted on a scale of tens of thousands of people, according to the sources.

JICA began its field survey in December last year. The agency has confirmed relevant legal systems in these countries to conduct clinical trials, which are usually carried out in three stages. It will also examine the systems for obtaining approval for production and sales of Japan-made vaccines as well as the availability of facilities capable of producing the vaccines in order to enable patients to continue to receive them after the clinical trials, according to the sources.

To ensure smooth progress of clinical trials, JICA also intends to begin training for local medical professionals, researchers and other relevant personnel by teaching such matters as clinical test methods and the situation of drug development in Japan, in cooperation with Japanese pharmaceutical companies.

From fiscal 2024 and later, JICA plans to consider extending economic assistance and technical cooperation under the framework of official development assistance, the sources said.

The Tokyo-based National Center for Global Health and Medicine, which serves as a bridge between Japan and overseas medical institutions, has also launched work to create an environment for clinical trials by concluding a memorandum of understanding with hospitals in Asia that will cooperate. It plans to accelerate the effort by working with JICA.

The establishment of such an overseas clinical trial network has been included in a national strategy to strengthen research and development concerning new infectious diseases. The government obtained Cabinet approval of the strategy in June 2021.