30 years of neglecting the vaccine industry, Japan now has to rely on foreign sources

The vaccine industry that once played a vital role in Japan has been left to wane for years due to the timidity of Japanese officials.
While the whole world is rushing to develop a Covid-19 vaccine, no vaccine manufactured by the Japanese company has been approved. Nikkei Asia Japan has been left behind the US, UK, China, Russia and many countries in the race to develop a vaccine against Covid-19.

The root cause is believed to be 30 years of not trying to clear people’s doubts about vaccine side effects, according to the above article. Nikkei Asia 10/5. The landmark court ruling of 1992 During the 1980s, Japan possessed world-leading vaccine technology for the treatment of chickenpox, encephalitis, and pertussis. These technologies are licensed to the US and other countries. But vaccine development in Japan came to a near complete halt following a 1992 court ruling ordering the government to compensate people for side effects after vaccination. The Japanese people see this as a landmark ruling that opens the way for victims to seek compensation on a broader scale. A Japanese official injects a vaccine against Covid-19. Photo: Reuters. The Japanese government did not appeal the ruling. Vaccination was also no longer mandatory after the government revised the law in 1994. Since then, vaccination rates in Japan have declined as parents become more concerned about side effects. The AIDS crisis also has a negative impact. In 1996, a Japanese health ministry official was convicted of negligent manslaughter following a scandal involving HIV-contaminated blood products. Despite the government’s efforts to hold responsible, the incident still made officials in Japan feel that they would suffer the consequences if anything happened, while the politicians were unharmed. Gaps in policy Japan is currently facing a “vaccine gap”. In the US and Europe, the product licensing process takes only a few years, but in Japan it is more than 10 years. The Japanese Ministry of Health has issued a special license for the Pfizer vaccine to be administered to the elderly, but this licensing process only applies to foreign vaccines. Meanwhile, the US administration has accelerated vaccine development since the 2001 anthrax attack. When there is a public health crisis in the country, the US Department of Health and Human Services will coordinate with other agencies. research institutes and pharmaceutical companies to respond appropriately. The agency also supports development budgets, clinical trials, as well as emergency approvals. The global vaccine market is growing by nearly 7% per year. New vaccines are released every time a new deadly infectious disease emerges, such as Middle East Respiratory Syndrome (MERS) and Ebola. The mRNA technology used in making vaccines has been studied for the past 20 years and is being applied to fight Covid-19. But private companies in Japan can hardly solve this problem alone because of the lack of motivation to promote the development, purchase, or stockpile of vaccines. Japan currently does not have a domestically produced vaccine. Photo: AFP. “There is a gap in the vaccine because there is still a gap in policy,” said Tetsuo Nakayama, a professor at Kitasato University in Tokyo. One can mention the case of UMN Pharma, a Japanese biotech company that uses new technology to develop flu vaccines. UMN Pharma used to spend more than $100 million to build a manufacturing plant, but the company’s application for a license was rejected in 2017. The grounds for the rejection were that the product “lacked clinical importance” compared to vaccines. available. UMN Pharma currently has negative total assets and is owned by Shionogi – another Japanese pharmaceutical company. The vaccine made by UMN Pharma has been approved in the US. This has led one in the Japanese vaccine industry to question whether anyone still wants to make new vaccines in the country. Complicated legal regulations Technology and research talent are also flowing outside of Japan. “Japan has a lot of regulations but it has a weak support system,” said one virus expert. The country has only two research facilities that can handle the most dangerous viruses. But one of the two establishments has only recently reopened because it was previously opposed by the local people. Public Administration Reform Minister Taro Kono was appointed on January 18 as the person in charge of Japan’s vaccination campaign. Photo: Japan Times. Vaccine research in Japan is subject to complicated regulations by many ministries. Experiments involving gene editing are limited to the Cartagena Protocol. This is an international legal document on biosafety management with genetically modified organisms that Japan has approved. Meanwhile, Europe exempts pharmaceutical companies from applying the Cartagena Protocol. The United States has not yet ratified this document. Japanese manufacturers even ignore the domestic market. Takeda Pharmaceutical, for example, has no plans to license its dengue vaccine in Japan. The same thing happened with the vaccine made from tobacco leaves of Mitsubishi Tanabe Pharma company. In the immediate future, Tokyo has quickly appointed a minister in charge of the Covid-19 vaccine. But products made by AnGes, Shionogi, and other Japanese companies are not expected to be approved before 2022.