Moderna vax approved in Japan, South Korea

May 21, 2021

Japanese and South Korean regulators have officially approved Moderna's COVID-19 vaccine, alongside the vaccine produced by AstraZeneca and Oxford University.

The Ministry of Food and Drug Safety of South Korea (MFDS) has approved Moderna's application for Conditional Marketing Authorization for its mRNA vaccine and GC Pharma will distribute it. Moderna announced earlier this year that it plans to open a commercial subsidiary in South Korea in 2021.

The Ministry of Health, Labour and Welfare (MHLW) of Japan granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna’s vaccine, and distribution by Takeda will begin immediately. Moderna launched a commercial subsidiary in Japan, Moderna K.K., in April 2021 and is now actively hiring locally.

Previously, only the Pfizer vaccine had been authorized for use in Japan, where just 4 percent of the population has received a first shot. Japan is in the midst of a deadly fourth wave of infections, just two months before the Summer Olympics in Tokyo are set to begin.

In addition to South Korea and Japan, Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in the U.S., Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei and Paraguay, and an Emergency Use Listing  from the World Health Organization (WHO).