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Takeda wins approval to distribute Novavax’s COVID-19 vaccine in Japan

By Brian Buntz | April 20, 2022

Takeda/NovavaxTakeda (NYSE:TAK) has announced that it has won manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid, a novel COVID-19 vaccine.

Nuvaxovid (NVX-CoV2373) was initially developed by Novavax (Nasdaq:NVAX).

The approval covers the use of the vaccine as both a primary and booster immunization in adults at least 18 years old.

Nuvaxovid is a recombinant protein-based vaccine.

Sanofi (Nasdaq:SNY) and GSK (NYSE:GSK) are also jointly developing a similar COVID-19 vaccine. Sanofi and GSK also announced their intent to file international regulatory submissions for their recombinant protein-based COVID-19 vaccine candidate.

Osaka, Japan–based Takeda won regulatory approval after submitting efficacy and safety data from a Phase 1/2 study in Japan and data from two pivotal Phase 3 trials in the UK, U.S. and Mexico. The company also submitted data from Phase 1/2 studies in Australia and Phase 2 data from South Africa.

“COVID-19 continues to pose a significant threat to the health and well-being of our global community,” said Dr. Gary Dubin, president of the global vaccine business unit, Takeda, in a press release. “We are proud to contribute to the development of Nuvaxovid and to manufacture the vaccine at our Hikari facilities, continuing our commitment to the COVID-19 public health response in Japan.”

Novaxovid lacks the stringent storage requirements of some of the first COVID-19 vaccines. It can be stored at 2–8℃ and be transported via the traditional vaccine supply chain.

NVAX stock ticked down 2.16% to $53.41 in mid-morning trading while TAK shares were up 1.48% to $14.73.


Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease
Tagged With: COVID-19 vaccine, Novavax, Nuvaxovid, Takeda
 

About The Author

Brian Buntz

As the pharma and biotech editor at WTWH Media, Brian has almost two decades of experience in B2B media, with a focus on healthcare and technology. While he has long maintained a keen interest in AI, more recently Brian has made making data analysis a central focus, and is exploring tools ranging from NLP and clustering to predictive analytics.

Throughout his 18-year tenure, Brian has covered an array of life science topics, including clinical trials, medical devices, and drug discovery and development. Prior to WTWH, he held the title of content director at Informa, where he focused on topics such as connected devices, cybersecurity, AI and Industry 4.0. A dedicated decade at UBM saw Brian providing in-depth coverage of the medical device sector. Engage with Brian on LinkedIn or drop him an email at bbuntz@wtwhmedia.com.

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