OSAKA, Japan, May 21, 2021 --?Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (?Takeda?) today announced that the Ministry of Health, Labour and Welfare (MHLW) granted special approval under article 14-3 of the Pharmaceuticals and Medical Devices Act for emergency use of Moderna?s mRNA COVID-19 vaccine, TAK-919, now known as COVID-19 Vaccine Moderna Intramuscular Injection, in Japan. The approval is based on positive clinical data from Takeda?s Phase 1/2 immunogenicity and safety clinical trial of Moderna?s COVID-19 vaccine in Japan, which showed an immune response consistent with results from Moderna?s pivotal Phase 3 COVE trial conducted in the United States. Takeda plans to begin distribution in Japan immediately. ?This is an important step in Takeda?s support of Japan?s pandemic response,? said Rajeev Venkayya, president of the Global Vaccine Business Unit at Takeda. ?Moderna?s vaccine has demonstrated an excellent safety and effectiveness profile to date, and we are excited to make it available to the Japanese population.? The approval is the result of a three-way agreement announced in October 2020 with Moderna and Government of Japan?s Ministry of Health Labour and Welfare (MHLW) to distribute 50 million doses of TAK-919 in Japan in the first half of 2021. Takeda also entered into a collaboration with Novavax to develop, manufacture and commercialize Novavax? COVID-19 vaccine candidate (TAK-019) in Japan. Takeda?s efforts to bring the COVID-19 Vaccine Moderna Intramuscular Injection and Novavax? vaccine candidates to Japan are supported by the MHLW and the Japan Agency for Medical Research and Development (AMED). TAK-919 Clinical Trial?and Results Takeda is conducting a placebo-controlled Phase 1/2 study in Japan to?evaluate the safety and immunogenicity of two vaccinations of TAK-919?given 28 days apart. Takeda enrolled 200 participants aged 20 years?and older. Each participant?was?assigned to receive a placebo or a?0.5 ml?dose?of TAK-919?at both vaccinations. Participants will be followed?for?12 months after the second vaccination. This interim analysis showed that binding antibody and neutralizing antibody titers were elevated at 28 days after the second dose in 100% of people vaccinated with two 0.5ml doses of TAK-919 given 28 days apart. The vaccine candidate was generally well-tolerated with no significant safety concerns reported. Takeda intends to publish additional data in a peer-reviewed journal. About Takeda?s COVID-19 Efforts Takeda is taking a comprehensive approach to treat and prevent COVID-19 today,?and future pandemics?through multiple activities and partnerships including, but not limited to:

• Hyperimmune globulin: Takeda co-founded the CoVIg-19 Plasma Alliance and joined forces with other leading plasma companies to evaluate a hyperimmune globulin medicine in a global clinical trial. While the data did not meet its endpoints, the program has contributed to the scientific understanding of antibody-based treatment to address the virus and highlighted the broader therapeutic value and importance of plasma to treat rare diseases.
• Additional therapeutics:?The company has assessed existing Takeda products for activity against the COVID-19 virus and co-founded the?COVID R&D Alliance. In addition, Takeda has joined the Innovative Medicines Initiative (IMI) CARE consortium, the?Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership?and the COVID RED project.
• Vaccines:?Takeda has partnered with the Government of Japan,?Novavax?and?Moderna, to help accelerate the availability of COVID-19 vaccines. We are leveraging our extensive and well-established global manufacturing and supply capabilities and building upon our existing influenza pandemic preparedness efforts in Japan. Takeda also announced a mutual agreement with?IDT Biologika GmbH?(IDT) to utilize capacity at IDT for three months previously reserved for Takeda?s dengue vaccine candidate to manufacture the single-shot COVID-19 vaccine developed by Janssen Pharmaceutical Companies of Johnson & Johnson. Takeda supports our partners and alliances in a shared goal to rapidly discover, develop and deliver effective treatments and vaccines for COVID-19 and ensure preparedness for future pandemics.

Takeda?s Commitment to Vaccines Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For the past 70 years, Takeda has supplied vaccines to protect the health of people in Japan. Today, Takeda?s global vaccine business is applying innovation to tackle some of the world?s most challenging infectious diseases, such as dengue, COVID-19, Zika and norovirus. Takeda?s team brings an outstanding track record and a wealth of knowledge in vaccine development, manufacturing and global access to advance a pipeline of vaccines to address some of the world?s most pressing public health needs. For more information, visit?www.TakedaVaccines.com. About Takeda Pharmaceutical Company Limited Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discover and deliver life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people?s lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit?https://www.takeda.com. Media Contacts: Japanese Media Ryoko Matsumoto ryoko.matsumoto@takeda.com +81 (0) 3-3278-3414 Media Outside Japan Catherine Wilson catherine.wilson@takeda.com +1 440-488-6242 Important Notice For the purposes of this notice, ?press release? means this document, any oral presentation, any question and answer session and any written or oral material discussed or distributed by Takeda Pharmaceutical Company Limited (?Takeda?) regarding this release. This press release (including any oral briefing and any question-and-answer in connection with it) is not intended to, and does not constitute, represent or form part of any offer, invitation or solicitation of any offer to purchase, otherwise acquire, subscribe for, exchange, sell or otherwise dispose of, any securities or the solicitation of any vote or approval in any jurisdiction. No shares or other securities are being offered to the public by means of this press release. 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