Therapy Areas: Vaccines
Takeda and Moderna to transfer SpikevaxTM Japan marketing authorisation to Moderna
1 June 2022 -

Moderna, Inc., (Nasdaq: MRNA) a US-based biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and Japan-based pharmaceutical company Takeda (TSE:4502/NYSE:TAK) announced on Tuesday that they are to transfer the marketing authorisation in Japan for Moderna's COVID-19 vaccine SpikevaxTM (mRNA-1273) from Takeda to Moderna in Japan as of 1 August 2022.

Moderna will assume responsibility for all Spikevax activities, including import, local regulatory, development, quality assurance and commercialisation. 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 Stephane Bancel, Moderna's chief executive officer. 'We are happy to take this important step as we continue to build and strengthen our own commercial organisation in Japan, and we look forward to continuing our partnership 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 of Takeda's Global Vaccine Business Unit. 'Following transfer of the marketing authorisation to Moderna, we will continue to provide transitional distribution support to ensure supply continuity.'