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Pfizer applies for Japan COVID-19 vaccine approval

Inoculations set to begin by March after 'thorough' vetting process

The Pfizer-BioNTech COVID-19 vaccine has already received approval for emergency use in several countries, including the U.S., UK, and Singapore.    © Reuters

TOKYO -- U.S. drugmaker Pfizer on Friday applied to Japan's Ministry of Health for approval of its coronavirus vaccine, the company announced. The pharmaceutical giant is the first supplier to seek formal approval in Japan and has already agreed to supply the country with 120 million doses, enough for 60 million people.

The U.K. at the beginning of December was the first to approve Pfizer's vaccine, and inoculations began there last week. The U.S. and Canada have since followed.

In Japan, the number of new infections has been surging, heightening expectations for a vaccine maker to apply for approval.

Pfizer has been carrying out clinical trials on about 160 Japanese citizens since October. The trial period is expected to last until around the fall of 2021, but so far there have been no serious problems with those who have had their second of two shots.

The company decided to apply for formal approval in Japan after gathering data and results of clinical trials that it has conducted globally on about 40,000 people.

If the approval process goes smoothly, there is a high possibility that the company's vaccine will be the first to be available in Japan. The Ministry of Health, Labor and Welfare aims to start vaccinations by March.

Norihisa Tamura, Japan's health minister, told reporters on Friday that the vaccination approval process "will be thorough and done with the highest priority."

The government in December amended its law regarding immunizations, positioning coronavirus inoculations as an urgent need and making shots free of cost.

The government plans to prioritize medical workers and elderly people who are at high risk of becoming seriously ill during its initial treatment phase.

Pfizer's vaccine was reported to have caused some serious allergic reactions in the U.K. and the U.S., raising concerns about its safety, as well as its ability to maintain effectiveness.

Japanese Prime Minister Yoshihide Suga has stated that the country will "secure enough supplies [of the vaccine] to provide all citizens by the first half of 2021." In addition to Pfizer, Japan has agreed to receive 120 million doses from AstraZeneca and 50 million doses from Moderna.

Other drugmakers -- Shionogi, Johnson & Johnson and startup Anges among them -- are conducting COVID-19 vaccine trials in Japan.

Akihisa Harada, president of Pfizer Japan, said in a news release that the company's efforts to deliver safe and effective vaccines are rapidly moving forward with the help of regulators. Applying for approval in Japan "is based on data obtained from scientifically strict and highly ethical research and development," he noted, adding that "if approval is obtained, we will promptly deliver the vaccines to the Japanese people and would like to contribute to normalizing social life."

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