Japan depends on overseas vaccines due to 30 years of inaction

Prime Minister Yoshihide Suga’s visit to the US last month included a phone call to Pfizer chief executive Albert Bourla, as the Japanese leader sought to secure doses of the American company’s coronavirus vaccine.

Taro Kono, Japan’s minister for regulatory reform, is the point man for the country’s vaccination campaign. But Bourla let it be known that he wanted to speak with Suga directly.

Suga had little choice but to make the call. Japan lags far behind the US, the UK, China, Russia and even Vietnam and India in developing a coronavirus inoculation, the result of 30 years of inaction to dispel the public’s lack of confidence in side effects caused by vaccinations.

As the world rushes to develop Covid-19 vaccines, no homegrown Japanese version has been approved.

“We haven’t had the same explosion in cases like the US and Europe,” said a health ministry official who oversees pharmaceuticals. “We can observe the safety and effectiveness of vaccines abroad before introducing them to Japan.”

This article is from Nikkei Asia, a global publication with a uniquely Asian perspective on politics, the economy, business and international affairs. Our own correspondents and outside commentators from around the world share their views on Asia, while our Asia300 section provides in-depth coverage of 300 of the biggest and fastest-growing listed companies from 11 economies outside Japan.

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Through the 1980s, Japan possessed world-class vaccination technology for chickenpox, encephalitis and whooping cough that it licensed to the US and other countries.

But vaccine development ground to a virtual halt with a 1992 court decision that ordered the government to pay compensation related to side effects of inoculations.

The public viewed the ruling as a landmark decision that opened the way for wider compensation of victims, and the government dropped its appeal. Inoculations ceased to be mandatory after Japan amended a law in 1994, and the country’s vaccination rate declined as parents became more concerned about side effects.

The Aids crisis had an impact as well. In 1996, a health ministry official was convicted of negligent homicide in a scandal involving HIV-contaminated blood products in Japan. Despite the effort at accountability, the incident left an impression among bureaucrats that if anything goes wrong, they would take the blame while politicians would be off the hook.

Japan now faces a “vaccine gap”, as product approvals take several years in the US and Europe but require more than 10 for Tokyo. The BioNTech/Pfizer vaccine being administered to the elderly in Japan received special approval from the health ministry, but this procedure applies only to overseas vaccines.

By contrast, Washington accelerated its vaccine efforts after the 2001 anthrax attacks. When a public health crisis occurs in the US, the Department of Health and Human Services co-ordinates a response with research institutions and pharmaceutical companies. It provides support for development funding and clinical trials as well as emergency use approval.

The global vaccine market is growing nearly 7 per cent annually. New vaccines are developed whenever a new deadly viral illness emerges, such as the Middle East respiratory syndrome (Mers) or Ebola. Messenger RNA technology for use in vaccines has been studied for 20 years and is now being applied to fight Covid-19.

But it is difficult for a private company to take this on alone. Little momentum exists in Japan to support development, purchasing or stockpiling.

“There is a vaccine gap because there is a policy gap,” said Tetsuo Nakayama, a professor at Kitasato University in Tokyo.

The experience of UMN Pharma, which developed a flu vaccine employing a new technology, is telling. The biotech company spent more than $100m to build the plant, but its application for approval was rejected in 2017 on the grounds that the product “lacks clinical significance” compared with existing vaccines.

UMN Pharma now stands in negative net worth and under the wing of fellow Japanese pharma company Shionogi. The vaccine is already approved for use in the US, making one Japanese industry insider question why anyone in Japan would want to introduce a new vaccine.

Researchers and technology are flowing out of the country.

“Japan has a lot of regulations and a poor support system,” one virologist said. Only two research facilities in Japan can handle the most dangerous viruses, and one was not operating until recently due to opposition from local residents.

Vaccine research is governed by a complex web of regulations across ministries, while experiments that involve genetic modifications are bound by the Cartagena Protocol on Biosafety. Europe has exempted pharmaceuticals from the measure, and the US has not ratified it.

Japanese producers even bypass their home market. Takeda Pharmaceutical has no plans to seek approval in Japan for its dengue fever vaccine, nor does Mitsubishi Tanabe Pharma for an inoculation derived from a tobacco leaf plant.

Tokyo quickly put a minister in charge of Covid vaccines, but products being developed at home by AnGes, Shionogi and others are not expected to be approved until at least 2022, if at all.

A version of this article was first published by Nikkei Asia on May 10 2021. ©2021 Nikkei Inc. All rights reserved.

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