Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Nuvaxovid Intramuscular Injection, a novel recombinant protein-based Covid-19 vaccine developed by Novavax.
The regulatory approval allows the use of protein-based Covid-19 vaccine for primary and booster administration in Japanese people aged 18 years and above.
Novavax has licensed and transferred its technologies to Japanese pharmaceutical firm Takeda, enabling it to manufacture the vaccine locally at its facility in Hikari.
The Japanese government has agreed to purchase 150 million doses of Nuvaxovid, to be domestically manufactured by Takeda.
The Japanese drugmaker is planning to commence the distribution of Nuvaxovid doses, which will be purchased by the Government of Japan.
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.”
The regulatory approval was based on Takeda’s New Drug Application (NDA) submission, which was supported by the interim results from a Phase 1/2 study conducted in Japan.
It was also supported by positive data from several other studies, including two Phase 3 clinical trials in the UK, the US and Mexico, Phase 1/2 studies in Australia and Phase 1/2 study in Japan.
The Phase 1/2 study in Japan assessed the safety and immunogenicity of two primary series vaccinations, administered 21 days apart.
In the studies, the vaccine candidate was well-tolerated, with no serious adverse events reported.
The company said it submitted additional safety and efficacy data to support booster immunisation, including a Phase 2 study conducted by Novavax in South Africa.
Takeda has received funding support from the MHLW and Japan Agency for Medical Research and Development for the technology transfer and R&D efforts to manufacture Nuvaxovid domestically.
Earlier this month, Novavax and Serum Institute of India announced that the Thailand Food and Drug Administration (Thai FDA) granted emergency use authorisation (EUA) for Novavax’s protein-based Covid-19 vaccine.
