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.
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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…