Takeda (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.