Therapy Areas: AIDS & HIV
Moderna and South Korea Explore Collaboration on mRNA Vaccines
25 May 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has inked two Memoranda of Understanding with the government of South Korea, the company said.

These include one MoU with the Korea National Institute of Health, an agency of the Korea Centers for Disease Control and Prevention Agency for a new collaboration on mRNA vaccine research in South Korea.

The company inked 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 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, DC.

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.

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 US starting in 3Q21.

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 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 m doses of COVID-19 Vaccine Moderna.

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.

The COVID-19 Vaccine Moderna (referred to in the US as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center.

The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health on February 24, 42 days from sequence selection.

The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.

On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation.

On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine.

On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases.

On November 30, 2020, the company also announced that it filed for Emergency Use Authorization with the USFDA and a Conditional Marketing Authorization application with the European Medicines Agency. On December 18, 2020, the US FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older.

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

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA, to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed.

Moderna maintains alliances with a range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing.

Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases.