24 May 2021 | Monday | News
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced two Memoranda of Understanding (MoU) with the government of South Korea: one MoU with the Korea National Institute of Health (KNIH), an agency of the Korea Centers for Disease Control and Prevention Agency (KDCA) for a new collaboration on mRNA vaccine research in South Korea; and an additional MoU with the Ministry of Trade, Industry and Energy of the Republic of Korea (MOTIE), the Ministry of Health and Welfare of the Republic of Korea (MOHW) to explore local manufacturing opportunities for mRNA vaccines in South Korea.
The MoUs were signed today by Kwon Junwook, Director, KNIH and Stéphane Bancel, Moderna’s Chief Executive Officer at a signing ceremony in Washington, D.C. With these MoUs, Moderna and the KNIH will explore areas of collaboration for scientific research on mRNA vaccines. The teams will engage in discussions regarding collaboration opportunities such as pre-clinical or clinical development of mRNA vaccine candidates against viruses that create a high burden of disease in South Korea. These MoUs may also facilitate discussions between Moderna and South Korea for a potential manufacturing facility for mRNA vaccines in South Korea.
“We thank the South Korean government and we look forward to exploring this collaboration to bring mRNA vaccines that may help address areas of unmet need,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We will continue to explore options for establishing potential local manufacturing opportunities in South Korea.”
Also announced at the signing ceremony, Moderna and Samsung Biologics have entered into a Manufacturing Services and Supply Agreement in which Samsung Biologics in South Korea will provide large scale, commercial fill-finish manufacturing for COVID-19 Vaccine Moderna intended for the supply of markets outside of the U.S. starting in the third quarter of 2021.
Earlier this year, Moderna announced that as it continues to scale its commercial network, the Company plans to open a commercial subsidiary in South Korea in 2021.
The Ministry of Food and Drug Safety of South Korea (MFDS) approved Moderna’s application for Conditional Marketing Authorization for Moderna’s COVID-19 vaccine on May 21. GC Pharma in South Korea is the Company’s marketing authorization holder and distributor of Moderna’s COVID-19 vaccine for South Korea. South Korea has secured access to 40 million doses of COVID-19 Vaccine Moderna.
Authorized Use
Moderna’s COVID-19 vaccine is authorized pursuant to a Conditional Marketing Authorization in South Korea for use in adults aged 18 years and older.
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