On May 21, 2021, Moderna announced that the Ministry of Food and Drug Safety of South Korea (MFDS) had approved the Company’s application for Conditional Marketing Authorization for its mRNA vaccine against COVID-19. GC Pharma in South Korea is the Company’s marketing authorization holder and distributor of Moderna’s COVID-19 vaccine for South Korea.

The approval was based on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30, 2020. To date, South Korea had secured access to 40 million doses of COVID-19 Vaccine Moderna.

In addition to South Korea, Moderna had 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, Paraguay, Japan and an Emergency Use Listing (EUL) from the World Health Organization (WHO).