Moderna in Pacts with Samsung Biologics, Aldevron for COVID Vaccine MfgBy
Moderna has formed separate manufacturing pacts for its COVID-19 vaccine with Samsung Biologics, an Incheon, South Korea-based contract biologics manufacturer, and Aldevron, a CDMO of DNA plasmid, protein, and mRNA production. Also, the company reported updates of the vaccine globally.
Under the pact with Samsung Biologics, Samsung Biologics will provide large-scale, commercial fill-finish manufacturing for Moderna’s COVID-19 vaccine.
Upon execution of the deal, technology transfer will commence immediately (as reported on May 22, 2021) at Samsung Biologics’ facilities in Incheon, South Korea, using a production line equipped for aseptic fill-finish, labeling, and packaging services to support the production of hundreds of millions of doses of Moderna’s COVID-19 vaccine intended for the supply of markets outside of the US starting in the third quarter of 2021.
Separately, Moderna and Aldevron have expanded their collaboration in which Aldevron will supply plasmid DNA to serve as the genetic template for generating the COVID-19 mRNA vaccine and other investigational programs in Moderna’s pipeline.
Aldevron’s production of DNA continues to take place in its 70,000-square-foot facility in Fargo, North Dakota. Buildout and validation of an additional 189,000-square-foot expansion to the facility on Aldevron’s 14-acre campus has been completed to enable additional manufacturing capacity.
COVID-19 vaccine approvals and study updates
Moderna’s COVID-19 vaccine has also received approvals in Japan and South Korea.
Japan’s Ministry of Health, Labour and Welfare (MHLW) granted special approval for emergency use of Moderna’s mRNA COVID-19 vaccine. Distribution by Takeda in Japan will begin immediately (as reported on May 21, 2021).
Takeda and Moderna previously announced that Takeda will import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021. The companies have affirmed discussions with the Japanese government for an additional potential supply of 50 million doses from the beginning of 2022
As Moderna continues to scale its commercial network, its commercial subsidiary in Japan, Moderna K.K., is actively hiring locally. The subsidiary was incorporated in April 2021.
South Korea’s Ministry of Food and Drug Safety of South Korea (MFDS) also approved Moderna’s application for conditional marketing authorization for its COVID-19 vaccine. GC Pharma (formerly Green Cross Corporation), a Yongin, South Korean-based biopharmaceutical company, 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 Moderna’s COVID-19 vaccine.
Moderna also plans to open a commercial subsidiary in South Korea in 2021.
Additionally, the company announced two memoranda of understanding with the government of South Korea: (1) 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; and (2) with the Ministry of Trade, Industry and Energy of the Republic of Korea and the Ministry of Health and Welfare of the Republic of Korea to explore local manufacturing opportunities for mRNA vaccines in South Korea.
In a separate development, the company reported its Phase II/III study in the US of its COVID-19 vaccines in adolescents has met its primary immunogenicity endpoint. Moderna plans to submit these data to regulators globally in early June (June 2021).