~The Ministry of Health, Labor and Welfare has set aside ￥137.7 billion JPY ($1.3 billion USD) in subsidies to support companies in Japan that are working on COVID-19 vaccine production~
The American pharmaceutical giant Pfizer rolled out its COVID-19 vaccine in the United Kingdom on December 8, and several Japanese firms will embark on COVID-19 vaccine clinical trials from December 2020 onwards.
The United States Food and Drug Administration approved the Pfizer COVID-19 vaccine for emergency use on December 13, with rollout starting on December 14. Other vaccines are also lined up for similar consideration in the coming weeks.
For those living in Japan, however, the process might take a little longer. Government-run tests of the Pfizer vaccine are underway and are expected to continue in the next few months before the vaccine is approved for Japanese patients.
At the same time, Japanese pharmaceutical companies are moving forward with testing and accelerating preparation of their production lines, with the aim of supplying vaccines as swiftly as possible.
While Japan is lagging behind other countries in terms of a domestically-developed COVID-19 vaccine, the country is nevertheless keen on delivering Japan-made vaccines that are both safe and efficacious. It is speeding up the development as much as it can.
Largest Cell-culture Equipment in the World
In the town of Ikeda in Gifu Prefecture, at the biopharmaceutical company Unigen, one would see multiple pipes crammed into a room, where approximately 100 workers come in and out, carrying special materials and tools.
Unigen is working on vaccine production on behalf of the pharmaceutical firm Shionogi & Co., Ltd., which will start a clinical trial of a genetically-modified protein vaccine this December.
Unigen’s factory is swiftly preparing its COVID-19 vaccine production line at considerable speed. Its plant contains 21,000-liter cell-culture equipment, which is the largest in the world. The Japanese firm currently produces an influenza vaccine for the U.S. market on behalf of the French pharmaceutical giant Sanofi.
Shionogi aims to be capable of producing enough COVID-19 vaccine at the Gifu plant for at least 30 million people by the end of 2021.
It is rare for a pharmaceutical firm to start preparing its production line during the development stage, because there are no guarantees on practical use while a candidate vaccine is being carefully tested for efficacy and safety.
However, the Ministry of Health, Labor and Welfare has set aside ￥137.7 billion JPY ($1.3 billion USD) in subsidies to support companies in Japan, such as Shionogi, that are working on COVID-19 vaccine production. This is to ensure quick supply in the event that a candidate vaccine performs well in clinical trials.
“This project is designed to stabilize domestic supply through Japan-based production. We want to contribute to the swift supply of the vaccine to people in Japan by using our know-how on providing high-quality products on a mass scale,” said Unigen director Taro Toda.
In addition to Shionogi, the pharmaceutical firm Daiichi Sankyo is developing an mRNA vaccine, with the aim of proceeding to clinical trials in March 2021. Meanwhile, KM Biologics is working on an inactivated vaccine, and Takeda Pharmaceutical has teamed up with an American firm on a COVID-19 vaccine.
All of these Japanese companies are preparing their production lines.
Safety Check, Multiple Types of Vaccines Necessary
The first Japanese company to start a clinical trial of a COVID-19 candidate vaccine in Japan was the biopharmaceutical startup AnGes. Earlier in December, AnGes initiated a phase 2/3 placebo-controlled trial assessing the safety and efficacy of its candidate. The company’s final trial is expected to take place in 2021 and, if successful, AnGes will apply with the relevant certifying organizations with the aim of rolling out its vaccine.
Meanwhile, the Japanese government has agreed with Pfizer that the latter will supply Japan with 120 million doses (for 60 million people) of its vaccine.
Similarly, the British pharmaceutical firm AstraZeneca has agreed to supply Japan with 120 million doses of its vaccine, and the American company Moderna is set to provide 50 million doses of its one.
Compared to other countries, Japan is lagging behind in terms of COVID-19 vaccine development. Regarding this particular issue, a spokesperson for AnGes has said: “Once a pandemic goes global, it makes sense to prioritize supply in one’s own country. Japan’s development pace might be behind that of other countries, but domestic development remains important.”
Looking ahead, AnGes plans to keep working on development and production facilities.
Commenting on Japanese companies’ development and manufacture of vaccines using various types of new technology, Shionogi CEO Isao Teshirogi stated: “Ensuring safety for people in Japan is important. Japan needs a framework that can deliver that kind of technological infrastructure.”
Moreover, AnGes founder and Osaka University Endowed Chair Professor Ryuichi Morishita said: “With a vaccine, it is necessary to confirm efficacy and adverse reactions over a long period of time. There is a need to develop multiple types of vaccines, to provide different options.”
Morishita added, “Japan needs to not only support preparation of facilities, but also subsequent maintenance,” referring to the production framework needed for the supply of vaccines across Japan.
(Read the original column in Japanese here.)
Author: The Sankei Shimbun