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Japan depends on overseas vaccines due to 30 years of inaction

Bureaucratic timidity allowed a once vital industry to wither away

Tokyo Metropolitan Cancer and Infectious Center Komagome Hospital's president Terumi Kamisawa receives a dose of the vaccine against the coronavirus disease. Japan has no homegrown coronavirus vaccine that has been approved.   © Reuters

TOKYO -- Prime Minister Yoshihide Suga's visit to the U.S. last month included a phone call to Pfizer CEO 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 U.S., the U.K., 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 scrambles to develop COVID-19 vaccines, no homegrown Japanese version has been approved.

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

Through the 1980s, Japan possessed world-class vaccination technology for chickenpox, encephalitis and whooping cough that it licensed to the U.S. 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 U.S. and Europe but require more than 10 for Tokyo. The 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 U.S., the Department of Health and Human Services coordinates 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% annually. New vaccines are developed whenever a new deadly viral illness emerges, such as Middle East respiratory syndrome 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 $100 million 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 U.S., 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 U.S. 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-19 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.

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