The Japan Ministry of Health, Labour and Welfare (MHLW) has granted manufacturing and marketing approval to Takeda’s Covid-19 vaccine, Nuvaxovid Intramuscular Injection, for initial and booster vaccination in people of the age 18 years and above.
The recombinant protein-based Covid-19 vaccine contains Matrix-M adjuvant.
It can be stored at a refrigerated temperature of 2℃ to 8℃ and requires a standard vaccine supply chain for transportation.
In August 2020, Takeda and Novavax entered a collaboration to develop, manufacture and supply the latter’s Covid‑19 vaccine candidate in Japan.
Under the deal, Novavax licensed and transferred its manufacturing technologies that enabled Takeda in the development and production of the vaccine at its facility in Hikari, Japan.
Through the MHLW and Japan Agency for Medical Research and Development, Takeda obtained funds for the technology transfer as well as research and development to produce the vaccine at the Hikari site.
With the latest approval, Takeda will commence supply of the vaccine doses procured by the Government of Japan in the coming days.
The MHLW approval is based on the New Drug Application (NDA) submission made by Takeda which comprises positive interim data from a Phase I/II trial in Japan as well as various other studies in the UK, US, Mexico and Australia.
Interim results from the Phase I/II trial were found to be in line with priorly reported trial data.
Furthermore, no serious adverse events were noted in the trial and the vaccine was found to be well-tolerated.
Additional safety and efficacy findings were presented to the regulatory agency to support booster vaccination, including from a Phase II trial carried out by Novavax in South Africa.
Takeda Global Vaccine Business Unit president Gary Dubin said: “Covid-19 continues to pose a significant threat to the health and well-being of our global community.
“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.”
In September last year, the MHLW agreed to purchase 150 million doses of the vaccine following approval.