Therapy Areas: Vaccines
Takeda to Transfer Marketing Authorization for Spikevax COVID-19 Vaccine in Japan to Moderna
31 May 2022 - - US-based biotechnology company Moderna, Inc., (NASDAQ: MRNA) and Japanese pharmaceutical company Takeda (TSX: 4502) (NYSE: TAK) have agreed to transfer the marketing authorization in Japan for Moderna's COVID-19 vaccine Spikevax (mRNA-1273) from Takeda to Moderna in Japan as of August 1, 2022, the companies said.

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.

Moderna's COVID-19 vaccine Spikevax 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 second dose should be given as soon as possible if more than four weeks have passed since the first vaccination. A booster dose may be given at least five months after the second dose for people aged 18 years and older.

A fourth dose may be given at least five months after the third dose for the elderly etc. considering the benefits and risks.

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 seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for rapid clinical and commercial production at scale.

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

Most recently, Moderna's capabilities have come together to allow the authorized use and approval 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.

Moderna has been named a top biopharmaceutical employer by Science for the past seven years.

Takeda is a global, values-based, R and D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet.

Takeda focuses its R and D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology.
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