- Japan’s Ministry of Health, Labour and Welfare Granted Regulatory Approval of a 50 µg Booster Dose of Moderna’s COVID-19 Vaccine, Now Known as SpikevaxTM Intramuscular Injection
OSAKA, Japan, December 16, 2021 -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval for a 50 µg booster dose of SpikevaxTM Intramuscular Injection, previously known as COVID-19 Vaccine Moderna Intramuscular Injection in Japan for administration at least six months after completion of the primary series in those who are 18 years and older. The approval is based on previously reported, positive Moderna Phase 2 study results. Moderna’s COVID-19 vaccine was previously granted conditional marketing authorization by the European Medicines Agency (EMA) and Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) based on the same study results.
Moderna’s Phase 2 study was amended to offer a 50 µg booster dose to interested participants aged 18 years and older six to eight months following their second dose of the primary series of Moderna’s COVID-19 vaccine. The results showed that a booster dose of the vaccine greatly increased neutralizing titers measured against the original virus strain compared to pre-boost levels. The reactogenicity profile observed following the booster dose was similar to the second dose of the primary series and the safety profile was also similar to that following any dose of Moderna’s COVID-19 vaccine of the primary series.
“We are proud to help protect the people of Japan through the distribution of the booster dose of SpikevaxTM Intramuscular Injection,” said Masayuki Imagawa, head of the Japan Vaccine Business Unit at Takeda. “Following the announcement from the Japanese government to accelerate the interval between the second and third doses as much as possible, rather than waiting eight months, this approval helps expand the supply of vaccines that can be used for booster administration.”
Takeda is committed to importing and distributing a total of 100 million doses of SpikevaxTM Intramuscular Injection. To date, 50 million doses of Moderna’s COVID-19 vaccine have been imported to Japan, and Takeda aims to begin importation and distribution of an additional 50 million doses from the beginning of 2022.
Takeda is proud to continue delivering safe and effective vaccines in the fight against the COVID-19 pandemic for the people of Japan. Takeda also recently submitted a New Drug Application (NDA) to Japan’s MHLW for Novavax’ recombinant COVID-19 vaccine candidate, known as TAK-019 in Japan and NVX-CoV2373 outside Japan. Through its collaboration with Novavax, Takeda is providing sustained access to COVID-19 vaccines in Japan and establishing the capability to manufacture TAK-019 at its facilities in Japan, aiming to begin distribution in early 2022, pending regulatory approval.
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:
Vaccines prevent 2 to 3 million deaths each year and have transformed global public health. For more than 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, pandemic influenza and Zika. Takeda’s team brings an outstanding track record and a wealth of knowledge in vaccine development and manufacturing 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.
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 and regions. For more information, visit https://www.takeda.com.
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