January 30, 2021

Article at Washington Post

View original

Japan’s pharmaceutical industry is huge. But it was left behind in race to get vaccines to Japanese citizens.

TOKYO — Years before the first coronavirus case, a team of Japanese Health Ministry advisers issued a warning: Japan's vaccine industry was seriously uncompetitive, public awareness about vaccine safety was low, and the country faced serious risks if a pandemic broke out.

“Vaccines are an essential part of national security,” the report warned in 2016, urging a series of reforms to ramp up research and production capacity — while there was still time.

Japan is the only nation in the Group of Seven economic powers still waiting to start vaccinations, but it is not alone among wealthy nations. Australia and South Korea are among nations still waiting to start vaccine programs.

But Japan — often ranked as the third-largest pharmaceutical market after the United States and China — stands as a vivid example of how the pandemic has forced nations to reexamine public health priorities, global cooperation and readiness.

Out of 63 vaccines undergoing clinical trials around the world, just one is from Japan, according to the World Health Organization. And even that one, from start-up AnGes in Osaka, will not enter Phase III trials until much later this year, Japan’s Health Ministry said.

Meanwhile, Japan’s failure to swiftly obtain vaccines from abroad points to other problems: deeply ingrained bureaucratic caution and a distrust of foreign pharmaceuticals. Japan requires vaccine trials to be inside the country, a demand that has significantly slowed down the approval process for the Pfizer, Moderna and Astra Zeneca vaccines it wants.

Japanese trials for the Moderna vaccine began only on Jan. 21, on just 200 people. Takeda Pharmaceuticals, Japan’s biggest drugmaker which is handling the trials, says it hopes the vaccine could be approved in May “at the latest,” according to a spokesman, with 50 million doses promised.

AstraZeneca started tests inside Japan in September, but the company is not expected to apply for approval to use the vaccine in Japan until late February. Still, officials told local media on Thursday that 90 million doses would be made inside Japan, with another 30 million imported.

“Strategically, Japan has not put vaccines high on the agenda in terms of national security,” said Kenji Shibuya, director of the Institute of Population Health at King’s College London and one of the authors of the 2016 report. “It has been pointed out repeatedly that securing vaccines proves really challenging in a time of crisis.”

Shibuya compares the situation in the vaccine industry with Japan’s financial industry before a crash in 1991. “So many companies, a lack of competitiveness, obviously heavily subsidized, a lack of global scale,” he said.

In August, shortly before retiring on health grounds, Prime Minister Shinzo Abe announced that Japan was working to secure enough vaccine doses to cover the entire population in the first half of this year. The pledge underscored official confidence that the Olympics could go ahead this July — even if the two issues were not explicitly linked.

The government said last year it would get 290 million doses from Pfizer, Moderna and AstraZeneca, as the country hedged its bets.

But the optimism about the vaccination timetable — and about the Olympics — has largely evaporated, thanks to a combination of Japan’s testing requirements and predictable bottlenecks in global supplies.

This month, the government was forced to declare a second state of emergency in Tokyo amid a surge in infections. Negotiations with vaccine makers were accelerated, and senior cabinet minister Taro Kono was appointed to oversee the vaccination process on Jan. 18.

On Thursday, Kono said he hoped to begin vaccinations for those over 65 years old on April 1 at the earliest, and hoped to finish by the third week of June. But he said he did not know when vaccines would be available for the rest of the general public.

But Japan also has to contend with a population widely skeptical about vaccine safety, and a bureaucratic culture that is deeply cautious.

That is partly because of complications that arose during compulsory vaccinations for measles, mumps and rubella in 1993 and a series of lawsuits that followed. The government reacted by abandoning the idea of making vaccines compulsory but also virtually stopped educating people about vaccine safety, giving the country a reputation as a “vaccine backwater.”

In 2013, Japan controversially withdrew an HPV vaccine after relatively minor side effects were reported, a decision that may have cost thousands of lives.

“In Japan, the atmosphere is very important. And we have an atmosphere that the vaccines are very dangerous, risky, and you don’t want to touch them,” said Kentaro Iwata, an infectious-disease expert at Kobe University.

“Unless you change this atmosphere into a positive atmosphere that the vaccine is good for your health, people will be very hesitant to come to the clinic,” he added.

Rochelle Kopp, a management consultant based in Japan, says the overall caution is also rooted in Japanese culture, an expectation of “perfection,” combined with an intolerance for mistakes and a tendency to apportion blame when things don’t turn out perfectly.

At the start of the pandemic, Japan’s Health Ministry was very slow to ramp up coronavirus testing and reluctant to introduce private-sector or foreign test kits over concerns about accuracy.

Nearby, South Korea was much faster in introducing coronavirus testing last year, but it, too, has yet to start vaccinating people, prompting criticism of the government.

“South Korea’s virus situation was relatively stable compared to other countries, but it can’t be an excuse for complacency,” said Kim Yoon, professor of health policy and management at Seoul National University. “Risk-averse bureaucrats were hesitant about procuring the newly developed vaccines, even though the unprecedented health crisis called for out-of-the-box thinking.”