U.S. biotechnology firm Moderna Inc. is planning to file for the Japanese health ministry's approval of its novel coronavirus vaccine as early as Friday, several people familiar with the matter said Tuesday.
The request would be the third such application for regulatory approval in Japan and will be filed with Takeda Pharmaceutical Co., Moderna's partner for its vaccine's clinical study and distribution in Japan.
Takeda recently said it has finished the enrollment of study candidates in Japan for Moderna's COVID-19 vaccine in early February, aiming to gain government approval and start distribution in the first half of this year.
Based on an agreement with the Japanese government, Takeda will import and distribute 50 million doses of Moderna's vaccine, or enough for 25 million people.
The first batch of 40 million doses will be received by the end of June and a further 10 million doses by the end of September.
Each person would need two shots of the vaccine, spaced 28 days apart.
Japan has already started administering Pfizer Inc.'s coronavirus vaccine to health workers last month in the first phase of its vaccination program.
Britain's AstraZeneca Plc filed a request for Japan's Ministry of Health, Labor and Welfare to approve its COVID-19 vaccine in early February.
Moderna's vaccine uses the same messenger RNA technology as Pfizer's.
Its efficacy rate is 94.1 percent, according to a U.S. study conducted on 30,000 participants, and is already being administered in the United States and in Europe.
Anaphylaxis from the vaccine is extremely rare, with one out of 400,000 recipients getting a severe allergic reaction, according to a study from the U.S. Centers for Disease Control and Prevention.
While Pfizer's vaccine needs to be kept at a temperature of around minus 75 C for long-term storage, Moderna's product can be stored for some six months at minus 20 C.