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COVID vaccines

Takeda seeks fast-track review of Moderna vaccine in Japan

Drug giant aims to supply doses for 20m people by June

A decision on Takeda's application for the Moderna vaccine will likely be made after results from a Japanese clinical trial are submitted.   © Reuters

TOKYO -- Takeda Pharmaceutical has asked the Japanese government to fast-track its application for Moderna's coronavirus vaccine, with plans to begin distribution by June.

Moderna is the third COVID-19 vaccine maker to undergo regulatory review in Japan, after Pfizer and AstraZeneca. Takeda is the one-stop agent for Moderna's vaccine here, handling clinical trials, application filing and distribution.

The filing is based on data from abroad. A decision on the application will likely be made once results from a Japanese trial with around 200 participants, due out in May, are submitted.

The two-dose vaccine will be imported from European production facilities through such logistics companies as Kintetsu World Express. Plans are to provide enough doses for 20 million people by June and for an additional 5 million people by September.

Like Pfizer's vaccine, which has obtained emergency approval in Japan, Moderna's product uses messenger RNA technology and does not contain the virus itself. It showed 94.1% efficacy in a Phase 3 trial with 30,000-plus participants in the U.S.

The vaccine can be stored at a standard freezer temperature of minus 20 C for six months and at refrigerator temperatures for 30 days. It is administered in doses 28 days apart.

Takeda will work with the health ministry to procure 15,000 coolers for shipping and storage from Japanese appliance maker Twinbird and elsewhere. Takeda's 5,000 units will be used for ground transportation, with the 10,000 units to be purchased by the government going to medical institutions.

Japan's vaccination program has lagged behind countries in the West as well as such Asian counterparts as China and India. The rollout of the Pfizer vaccine began in mid-February, initially limited to health care workers, and AstraZeneca's application filed that month is under review.

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