OSAKA, JAPAN & CAMBRIDGE, MASS.-- April 19, 2022 -- Takeda (TSE:4502/NYSE:TAK) today announced that it has received manufacturing and marketing approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for Nuvaxovid® Intramuscular Injection (Nuvaxovid), a novel recombinant protein-based COVID-19 vaccine, for primary and booster immunization in individuals aged 18 and older. Novavax licensed and transferred its manufacturing technologies to enable Takeda to develop and manufacture the vaccine at its facility in Hikari. Takeda will begin distribution of Nuvaxovid doses purchased by the Government of Japan as soon as possible.

“COVID-19 continues to pose a significant threat to the health and well-being of our global community,” said Gary Dubin, M.D., 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.”

The approval is based on Takeda’s New Drug Application (NDA) submission which included interim results from a Phase 1/2 study conducted by Takeda in Japan and several studies conducted by Novavax, including two pivotal Phase 3 clinical trials in the U.K., the U.S. and Mexico, and Phase 1/2 studies in Australia and the U.S. Interim results from the Phase 1/2 study in Japan were positive and consistent with previously reported clinical trial results. No serious adverse events were reported in this study and the vaccine candidate was well-tolerated. Additional safety and efficacy data were submitted to support booster immunization, including a Phase 2 study conducted by Novavax in South Africa evaluating a booster dose given 6 months after primary immunization.

Nuvaxovid is stored at a refrigerated temperature of 2 -8℃ and will be transported using a conventional vaccine supply chain.

Takeda received funding for the technology transfer and research and development to manufacture Nuvaxovid at its Hikari facility through the MHLW and Japan Agency for Medical Research and Development.

The financial impact of the vaccine on the full year consolidated financials for the fiscal year ending March 31, 2023 (Fiscal Year 2022) will depend on the specific distribution schedule. We will disclose the Fiscal Year 2022 forecast at the Fiscal Year 2021 financial results announcement scheduled in May 2022.

TAK-019 Clinical Trial

This placebo-controlled Phase 1/2 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 on February 24, 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 ClinicalTrials.gov identifier for this trial is NCT04712110.