Business
Moderna and Takeda Announce Plans to Transfer Marketing Authorization for Spikevax(TM) COVID-19 Vaccine in Japan to Moderna
Moderna to become marketing authorization holder in Japan and be responsible for all import, local regulatory, development, quality assurance, and commercial
About this update from Moderna, Inc.
[{"type":"text","content":"Moderna to become marketing authorization holder in Japan and be responsible for all import, local regulatory, development, quality assurance, and commercial activities for SpikevaxTM from August 1, 2022Companies concluded memorandum of understanding that Takeda will continue to provide distribution support for the Moderna COVID-19 vaccines for a transitional periodCAMBRIDGE, MA. and OSAKA, JAPAN / ACCESSWIRE / May 31, 2022 / Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Takeda (TSE:4502)(NYSE:TAK) have announced the transfer of the marketing authorization for Moderna's COVID-19 vaccine SpikevaxTM (mRNA-1273) from Takeda to Moderna in Japan as of August 1, 2022.Moderna will assume responsibility for all Spikevax™ activities, including import, local regulatory, development, quality assurance, and commercialization. Takeda will continue to provide distribution support under the current national vaccination campaign for Moderna COVID-19 vaccines for a transitional period. Both companies will be responsible for ensuring proper implementation of operations associated with this transfer.\"We thank Takeda for their support and partnership in bringing our COVID-19 vaccine to Japan over the last two years, and for helping to play a key role in addressing the pandemic across the country,\" said Stéphane Bancel, Moderna's Chief Executive Officer. \"We are happy to take this important step as we continue to build and strengthen our own commercial organization in Japan, and we look forward to continuing our partnership with Takeda in 2022.\"\"We are proud to have been able to support the early public health response to the COVID-19 pandemic by using the Takeda network to provide Moderna's COVID-19 vaccine to the people of Japan,\" said Gary Dubin, M.D., President, Global Vaccine Business Unit at Takeda. \"Following transfer of the marketing authorization to Moderna, we will continue to provide transitional distribution support to ensure supply continuity.\"Authorized UseModerna's COVID-19 vaccine SpikevaxTM has been granted authorization for special approval by the Ministry of Health, Labour and Welfare of Japan. In Japan, it is indicated for the prevention of coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. A dose may be given to people aged 12 years or older. A ...