Why was Japan’s vaccine rollout slow compared with other countries? Experts have pointed out the stringent regulations of Japan’s approval process for new drugs, which require conducting clinical trials at home even in times of emergency — like the COVID-19 pandemic.
But during a radio program on Tuesday, vaccine rollout minister Taro Kono revealed that U.S. drugmaker Pfizer Inc. had included more than 100 Japanese residents in the United States in its clinical trials last year, since Japan was not among the countries where it conducted trials. The pharmaceutical company conducted trials in the U.S., Germany, Turkey, South Africa, Brazil and Argentina on more than 40,000 participants.
“When Pfizer said in July (2020) that it was going to conduct an international clinical trial, Japan was excluded because the number of patients (at that time) were considerably small compared with Western countries,” Kono said. “They thought that it would be meaningless to do it in Japan because it would only take time.”
Pfizer, however, included about 100 or so Japanese expats and exchange students in the U.S. in its clinical trial participants, telling Japan that they had data on Japanese nationals, he said.
“But the health ministry said it wouldn’t work because the food and diet are different in the U.S. than in Japan,” Kono said.
In the end, Japan conducted domestic clinical trials on about the same number of Japanese participants —160 — in October, delaying the start of the vaccine rollout, he said.
“It may have been all right if it were normal times, but in times of emergency, we need to assess the risks and benefits and decide what to do,” Kono said.
The government is reportedly eyeing the creation of a system that would enable drugs that have not been domestically approved to be temporarily used in times of emergency before the completion of clinical trials at home — provided that they have a proven track record overseas.
The radio program that aired Tuesday was recorded on Sept. 2, a day before Prime Minister Yoshihide Suga announced that he will not run in the ruling Liberal Democratic Party leadership race, effectively resigning from his post as Japan’s leader.
Since that announcement, Kono has emerged as a serious contender to replace Suga, leading in two recent public opinion polls as the top pick to be prime minister.
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