Commercial Moderna to take up Takeda’s Spikevax marketing authorization in...

Moderna to take up Takeda’s Spikevax marketing authorization in Japan


Spikevax by Takeda had been previously approved for the prevention of COVID-19 by the Ministry of Health, Labor and Welfare in Japan.

Takeda has now made official its plans to hand over the market authorization for the vaccine in Japan to Moderna. The transfer of market authorization of Spikevax is due to begin at the start of August this year.

Moderna is a U.S. based pharmaceutical company that has been active in the therapeutic industry for over a decade now. The company has made strides in the advancement of messenger RNA (mRNA) therapy, with several vaccines as well as other therapies under its belt. Moderna has linkages with not only other commercial entities but also governments across the globe. The pharma giant has seen its most recent success with the development of its COVID-19 vaccine, making it one of the earliest vaccines to enter the market and be one of the top in terms of efficacy as well. 

With this market authorization transfer by Takeda, Moderna can now oversee major activities related to the Spikevax Covid-19 vaccine in Japan. This includes the import, development, assurance of quality as well as marketing of the vaccine. Moderna will also engage with the local Japanese regulatory authorities for the sale of the vaccine.

Both Takeda and Moderna, however, will share the responsibility of proper implementations for the operations of this transfer.

Takeda has offered Moderna the market authorization and rights to distribution for a transitional period currently. The pharma company will be supplying Moderna with the vaccine as part of Japan’s COVID-19 vaccine drive in the fight against the virus. 

Spikevax is a two dose COVID-19 vaccine that can be administered to children and adults 12 years old and above. Adults can opt for a booster dose of the vaccine five months after their last jab. The elderly can even opt for a fourth dose of Spikevax five months after their third dose, after weighing the benefits and risks. The vaccine has been approved by Japan’s Ministry of Health, Labor and Welfare.

Moderna views this opportunity as a way to expand its presence in Japan, with the company’s CEO stating that Moderna was excited to take this step for the expansion of the company’s footprint in the Japanese market. Through the new partnership with Takeda, Moderna hopes that their commercial growth can be furthered in the region.

Takeda President assured that during this transitional period, Takeda will offer its full support in the distribution of the vaccine so as to not disrupt the supply which would hinder Japan’s inoculation efforts. 

Last year, Takeda had signed an agreement with both the Japanese Government and Takeda which allowed it to import as well as distribute Moderna’s COVID-19 vaccine. The deal allowed for the import of 50M doses of the vaccine.

Takeda representative commented on the deal by stating that “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. Following transfer of the marketing authorization to Moderna, we will continue to provide transitional distribution support to ensure supply continuity.”

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