Japan’s development of COVID-19 vaccines is far behind that of global rivals.
With the general public unlikely to have access to Japan-made vaccines until 2022, industry sources say reasons include a failure by the nation to address problems such as a lack of consolidation within the pharmaceutical industry and the sheltering of relatively small Japanese firms from international competition.
This week the U.K. became the first Western country to begin inoculating its citizens with a commercially available COVID-19 vaccine. The same day, biotech startup AnGes Inc. — Japan’s front-runner, which has teamed up with Takara Bio Inc. and Osaka University — announced it had started a mid- to late-stage clinical trial of its DNA-based vaccine involving 500 healthy adults at eight facilities in the nation.
A total of 52 vaccine candidates were in clinical evaluation worldwide as of Tuesday, according to the World Health Organization, of which the one under development by AnGes was the only Japanese contender. Other candidate vaccines under development in the nation are still in preclinical evaluation.
Though U.S. pharmaceutical firms Pfizer Inc. and Moderna Inc. and U.K. drugmaker AstraZeneca PLC have developed vaccine candidates in under a year, it is unlikely that Japanese vaccines will be made available to the general public until 2022, says Dr. Tetsuo Nakayama, a project professor at Kitasato Institute for Life Sciences and director of the Japanese Society of Clinical Virology.
In the past, the Japanese government used to take the lead in developing vaccines such as the MMR vaccine for measles, mumps and rubella, says Nakayama, but since the government lost a series of lawsuits in the 1990s seeking damages for side effects of the vaccines, the situation has changed completely. In 1993, the MMR vaccination program was discontinued in Japan amid heightened public concern.
“It’s not that Japan lacks the development capability,” Nakayama says. “But after the government losses, the government did not actively propel the development of new vaccines. That created a vaccine gap that lasted for more than 10 years, during which Japan was way behind other countries in introducing vaccines for children.
“The lack of initiative from the government led to few financial resources and human resources to develop vaccines,” he says, “which inevitably slows the pace of development.”
On top of that, Japan has faced other hurdles. While four massive pharmaceutical companies have dominated 70% of global vaccine markets, Japanese pharmaceutical companies have remained much smaller in size due to a lack of consolidation in the sector. This has resulted in research and development capabilities and international competitiveness that pales in comparison to overseas rivals, a government advisory task force on vaccines wrote in recommendations to the Ministry of Health, Labor and Welfare in 2016.
The report also said the country needs to get rid of its convoy system, which protects industry members from international competition by paying subsidies to domestic firms while remaining slow to adopt vaccines made overseas.
For example, Japan was among the last countries in Asia to begin vaccinations for Haemophilus influenzae type B, in 2008. Other developed nations had started the vaccination program more than 10 years earlier, following the deaths of many children and serious complications from the disease overseas.
Four years have passed since the report was published, but hardly any changes have been made to strengthen the international competitiveness of Japanese vaccine manufacturers, says Kenji Shibuya, a former member of the advisory task force and now a professor at King’s College London.
“These represent the structural and fundamental issue in Japan, which remains the same today,” Shibuya says. “I think it is also important to point out the (Japanese) government’s lack of vision and long-term strategy, and scientific and evidence-based approach to vaccines.”
Amid the COVID-19 pandemic, Japan is facing an uphill battle in the global vaccine race.
Pfizer brought its mRNA COVID-19 vaccine to market in less than a year — a fraction of the four years it took to make the mumps vaccine that had previously held the record as the fastest ever developed. Developing a vaccine usually takes around 10 years.
At home, AnGes plans to conduct a large-scale late-stage clinical trial next year for its plasmid DNA vaccine. Both mRNA and plasmid DNA vaccines are considered safer than earlier types because the pathogen itself is not used directly in their production. The startup is reportedly aiming to introduce the vaccine for the domestic market by the end of next year.
Ryuichi Morishita, AnGes founder and professor of clinical gene therapy at Osaka University, said last month that — given the lower prevalence of COVID-19 in Japan — it was difficult to conduct trials in Japan, and that it would likely conduct the final trial globally.
“Probably we will conduct the large clinical trial including Japan and also other countries,” Morishita said in English during a news conference held at the Foreign Correspondents’ Club of Japan on Nov. 26. “Especially, we have contacted several countries in the Asia-Pacific areas.”
Other Japanese pharmaceutical firms such as KM Biologics, a unit of Meiji Holdings Co., and Daiichi Sankyo Co. are planning to launch clinical trials next March.
Shionogi & Co. President Isao Teshirogi has said his firm is aiming to enter a clinical trial by the end of the month, and a large-scale trial in Japan and overseas next year.
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