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U.S. drugmaker Pfizer Inc.’s mRNA vaccine against COVID-19 has become the first to be formally approved for use in Japan, paving the way for inoculations to start from Wednesday, but significant challenges still lie ahead for local governments that must set up the necessary logistics for a smooth vaccine rollout.

Pfizer’s novel coronavirus vaccine got the final OK for emergency use from the health ministry on Sunday, two days after a government committee gave the shot its seal of approval.

Prime Minister Yoshihide Suga said the vaccine rollout would begin Wednesday with front-line health care workers.

"We will do all we can to deliver safe and effective vaccines to the people as soon as possible," he told the Lower House Budget Committee on Monday.

Yoshihide Suga | POOL / VIA AFP-JIJI
Yoshihide Suga | POOL / VIA AFP-JIJI

Vaccine approvals usually take a year or two, but the government shortened the review period to less than two months — scrapping the requirement for third-phase clinical trials within the nation as the toll of the pandemic mounted.

Nonetheless, Japan is still the last country among the Group of Seven nations to approve the vaccine due to the requirement for an additional clinical trial to be conducted on Japanese people to ensure safety. The U.K. and the U.S. approved the Pfizer shot, jointly developed by the U.S. pharmaceutical giant and Germany’s BioNTech SE, in December.

Late-stage trials of Pfizer’s vaccine conducted in the U.S. and five other countries on more than 43,000 participants, of which 5% were Asian, showed that it was 95% effective in preventing COVID-19.

The approval from Tokyo came despite the lack of a large clinical trial in Japan, as the number of COVID-19 cases in the nation remains significantly lower compared with other countries. Health minister Norihisa Tamura said Pfizer’s clinical trial in Japan on 160 people age 20 to 85 has confirmed the vaccine’s effectiveness in producing antibodies in line with the results from the large-scale trial conducted overseas.

"Citizens can choose whether or not to get the vaccine shot," said Taro Kono, the minister in charge of the rollout, during the Lower House Budget Committee session. "We believe the benefit outweighs the risk."

Skepticism against vaccines is deeply rooted in the nation. In a 2016 EBioMedicine study of 67 countries, 31% of Japanese were skeptical of vaccine safety, ranking third-highest following France (45.2%) and Bosnia and Herzegovina (38.3%).

The first shipments of Pfizer’s vaccines arrived at Narita International Airport from Brussels on Friday, carrying vials with enough vaccine for around 400,000 shots, according to Kyodo News.

Japan has signed a contract to receive 144 million doses of Pfizer’s vaccines, enough to inoculate 72 million people, by the end of 2021. But when the next shipments will arrive remains unclear as nations are racing to secure adequate supply to vaccinate their citizens, and each batch from Europe needs export authorization from the European Union.

The vaccines themselves, which need to be kept at minus 75 degrees Celsius, also present significant logistical challenges. The government has secured tens of thousands of deep freezers to store the vials.

Japan aims to source enough vaccines for all its residents by the end of June, but it is unlikely that herd immunity will be achieved within the nation and abroad by the time the Tokyo Olympics is slated to kick off in late July. Suga had hoped hosting the event would be seen as proof of humanity's triumph over the virus.

A staff member takes out a case with vials containing water from a pharmaceutical refrigerator during a mock inoculation exercise at a college gym, as Japan prepares for its COVID-19 vaccination campaign, in Kawasaki on Jan. 27. | REUTERS
A staff member takes out a case with vials containing water from a pharmaceutical refrigerator during a mock inoculation exercise at a college gym, as Japan prepares for its COVID-19 vaccination campaign, in Kawasaki on Jan. 27. | REUTERS

For the vaccine rollout, many local governments are having difficulty in securing large venues for mass vaccinations that have enough space for inoculated individuals to remain for up to 30 minutes, in case they start to experience symptoms of severe reactions such as anaphylaxis.

Municipalities are also worried about whether they can secure enough health care workers to administer the shots, at a time when hospitals are still having a hard time treating high numbers of severe COVID-19 cases.

Up to 20,000 front-line medical staffers at state-run hospitals are set to be the first to receive the vaccines, followed by 3.7 million other health care workers. Vaccination tickets will then be sent to about 36 million people age 65 and older by the end of March, with their inoculations slated to kick off from April, according to a government schedule. Pfizer's vaccines need to be administered in two shots three weeks apart.

Foreign residents in Japan who are registered as residents of a municipality, as well as diplomats, will be eligible for vaccinations. Kono is set to give a briefing Tuesday on the nation's vaccination plans.

Other priority groups include 8.2 million people with chronic conditions, 2 million nursing care workers and 7.5 million people age 60 to 64. Next will come the vaccinations for members of the general public age 16 and above.

The medicine regulator, the Pharmaceuticals and Medical Devices Agency, that screened Pfizer's vaccines said pregnant women should only receive the shots if the benefits of inoculation are judged to outweigh the risks.

The World Health Organization last month did not recommend the the vaccination of pregnant women due to insufficient data, but added that in cases where a pregnant woman has an unavoidable high risk of exposure — such as working in health care — vaccination may be considered in discussion with their doctor.

The government has signed contracts with Pfizer, fellow U.S. pharmaceutical firm Moderna Inc. and British drugmaker AstraZeneca PLC for a total of 314 million doses, enough for 157 million people. Japan’s population is 126 million, including about 3 million foreign residents. AstraZeneca filed for fast-track approval of its vaccine with the health ministry on Feb. 5, while approval of the Moderna vaccine is unlikely before May.

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