How are Japan-made vaccines shaping up?

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Development in Japan

The US-made Pfizer and Moderna vaccines are currently being rolled out in Japan, while a number of domestic firms are working to develop alternatives.

Bio-venture AnGes Inc., based in Osaka Prefecture, is conducting clinical trials on about 500 people of a vaccine that uses artificially synthesized DNA to help create antibodies to attack the coronavirus.

Shionogi & Co., a pharmaceutical company based in Osaka City, has been conducting clinical trials of a recombinant protein vaccine on 214 people since last December. Researchers artificially produce parts of the coronavirus protein through genetic recombination and administer it to induce antibodies.

In late March 2021, Tokyo-based pharmaceutical company Daiichi Sankyo Co. started clinical trials of an mRNA vaccine on 152 people. KM Biologics Co., a vaccine maker based in Kumamoto Prefecture, has also started testing an inactivated vaccine on 210 people. It uses killed coronavirus particles to create an immune response.

Bio-venture ID Pharma Co., based in Tokyo, aims to conduct clinical trials of a viral vector vaccine produced by inserting a part of the genes of the coronavirus into another harmless virus with genetic engineering technology.

Japan has had relatively few coronavirus cases, often making it hard for researchers to judge the efficacy of a vaccine in the final stages of testing, which involve subjects taking either a vaccine or placebo and going about their lives in the community. The chances of the participants becoming infected is lower than in other countries where tests have been conducted.

The Pharmaceuticals and Medical Devices Agency, or PMDA, which screens new drugs in Japan, says one option would be for the vaccine makers to conduct large-scale trials overseas after completing domestic preliminary trials on a small group of people.

Shionogi to tackle variants

Teshirogi Isao, president of Shionogi & Co., announced on May 10 that the company has also started developing vaccines in response to the rapidly spreading coronavirus variants.

Teshirogi said this involves an initial phase of cultivating proteins from the genetic information of the variants. He plans to use that to investigate which methods might work best.

He also stressed the importance of domestic vaccines, saying, “If variants unique to Japan emerge, we will face difficulty in handling them if there are no vaccine makers here.”

Overseas firms conduct trials in Japan

International pharmaceutical companies are also conducting clinical trials in Japan.

The central government has signed an agreement to buy vaccines from three European and American pharmaceutical companies. Of those, Pfizer applied for authorization in Japan by providing data from clinical tests conducted overseas, as well as from small-scale clinical trials conducted in Japan. In February, it was granted authorization for its mRNA vaccine, which is now being used in Japan.

Japan's Takeda Pharmaceutical Co. conducted domestic clinical tests of US firm Moderna's mRNA vaccine, leading to its approval on May 21. It has been in use since May 24.

British pharmaceutical firm AstraZeneca conducted clinical trials of its viral vector vaccine in Japan. It was also approved on May 21.

Takeda Pharmaceutical is conducting domestic clinical trials for US biotech firm Novavax's recombinant protein vaccine. Clinical trials are also underway in Japan for another US-made option: Johnson & Johnson's viral vector vaccine.

This information is accurate as of May 24, 2021.