- The Ministry of Health, Labour and Welfare (MHLW) Grants Regulatory Approval of Moderna’s COVID-19 Vaccine (COVID-19 Vaccine Moderna Intramuscular Injection) Following Positive Interim Results in Takeda’s Phase 1/2 Immunogenicity and Safety Clinical Trial
- Interim Results Indicate Immune Response Consistent with Moderna’s Pivotal Phase 3 COVE Trial Results
- Takeda Will Immediately Begin Distribution in Japan
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:
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.
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