Takeda Nuvaxovid COVID-19 vaccine approved in Japan
pharmafile | April 20, 2022 | News story | Research and Development |
Takeda’s Nuvaxovid Intramuscular Injection (Nuvaxovid) has been approved by the Japan Mnistry of Health, Labour and Welfare (MHLW). This is a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunisation in individuals aged 18 and older.
The approval is based on Takeda’s New Drug Application (NDA) submission, which included interrim results from a Phase I/II study conducted by Takeda in Japan, and several studies conducted by Novavax.
The placebo-controlled study in Japan evaluated the safety and immunogenicity of two vaccinations of TAK-019 given 21 days apart. The first of 200 subjects aged 20 years and older was dosed in Japan in February 2021, and each participant was assigned to receive a placebo or a 0.5 ml dose of TAK-019 at both vaccinations. Subjects have been followed for 12 months after the second dose of investigational product.
The vaccine is stored at a refrigerated temperature of 2-8 degrees celsius, and will be transported using a conventional supply chain.
“COVID-19 continues to pose a significant threat to the health and well-being of our global community,” said Gary Dubin, MD, President of the Global Vaccine Business Unit, Takeda. “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.”