We would like to inform you that today, on April 12, 2024, we have obtained manufacturing and sales approval from the Ministry of Health, Labour and Welfare for the recombinant coronavirus (SARS-CoV-2) vaccine "Nuvaquivod Intramuscular 1mL", which was applied for today. "Nuvaquivod Intramuscular 1mL" is a monovalent vaccine that is effective in preventing infections caused by SARS-CoV-2, including the Omicron strain JN.1 lineage. Unlike emergency use for widespread prevention under the pandemic, this vaccine is intended for distribution and use in cases where administration to a large number of individuals in a day is not anticipated. It is a vial preparation for a single 0.5mL dose of administration, which is suitable for circulation and use (refrigeration at 2-8°C). We plan to start supplying "Nuvaquivod Intramuscular 1mL" from mid-September.

In the subcommittee on research, development, production, and distribution of seasonal influenza vaccines and new coronavirus vaccines, which was held on May 29, 2024, by the Ministry of Health, Labour and Welfare's Public Health Science Advisory Board's Vaccination and Vaccine Subcommittee, the antigenic composition of the new coronavirus vaccine to be used for routine vaccination in the 2024/25 season was compiled as including antigens that induce higher neutralizing antibodies against the JN.1 lineage and its sub-lineages, and one dose of the monovalent JN.1 lineage was considered as an example. The approval of "Nuvaquivod Intramuscular 1mL" by the Ministry of Health, Labour and Welfare is based on non-clinical data that has shown the induction of neutralizing antibodies against the JN.1 lineage and its sub-lineages, including KP.2 and KP.3, in addition to data on the change of antigen strains in clinical and quality aspects.

Mitsuhiko Mori, Head of the Global Vaccine Business Unit, Japan Development Division, stated, "As the legal classification of the new coronavirus infection changes to a fifth-class infectious disease and routine vaccination for the new coronavirus begins in October, we are proud to be able to deliver the option of a monovalent recombinant protein vaccine adapted to the JN.1 lineage in the form of a two-dose vial preparation."

Masayuki Imakawa, Head of the Japan Pharma Business Unit Vaccine Division, said, "I am truly delighted that we can deliver Nuvaquivod manufactured at our Yamaguchi plant to many countries around the world. Our company will continue its efforts to prevent the severity and onset of new coronavirus infections and contribute to the improvement of public health in Japan through the provision of Nuvaquivod."

We have received support from the Ministry of Health, Labour and Welfare's emergency production system for vaccines and the Japan Agency for Medical Research and Development (AMED)'s vaccine development promotion project (research and development topic: development of the NVX-CoV2373 vaccine for the new coronavirus) in order to produce Novavax, Inc.'s vaccine candidate for the new coronavirus infection in Japan, including technology transfer, establishment and supply of production facilities, and subsidies for research and development.

The Novavax intramuscular injection is a vaccine that contains a recombinant spike protein (rS) antigen of the novel coronavirus (SARS-CoV-2), which was licensed by our company from Novavax, Inc. as a manufacturing technology. On April 19, 2022, it obtained approval from the Ministry of Health, Labour and Welfare for the manufacture and sale of the Novavax intramuscular injection (5mL) (discontinued supply) as a prevention for infectious diseases caused by SARS-CoV-2. Currently, it has obtained approval for initial immunization (1st and 2nd doses) for individuals aged 6 and above, and additional immunization (3rd dose and beyond) for individuals aged 12 and above. It is manufactured at our Koji Plant (Mitsuru-cho, Yamaguchi Prefecture).

Product overview of 'Novavax intramuscular injection 1mL'

About Takeda Pharmaceutical

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) aims to contribute to the health of people worldwide and a brighter future. The company is committed to creating innovative pharmaceuticals in areas and businesses such as digestive diseases and inflammatory diseases, rare diseases, plasma-derived therapies, oncology (cancer), neuroscience (mental disorders), and vaccines. In partnership with others, Takeda is working to create a strong and diverse pipeline of new treatment options to improve the quality of life of patients. Takeda Pharmaceutical Company, based in Japan, is a research and development-oriented bio-pharmaceutical-leading company that is at the forefront of its focus on patient-centric values, based on the corporate philosophy that has been shaped for over two centuries. It is active in about 80 countries and regions to fulfill its value (values) based on those values. Please see for more details.

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