COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919) Description
The COVID-19 Vaccine Moderna Intramuscular Injection is an mRNA vaccine targeted against the SARS-CoV-2 coronavirus encoding for a prefusion stabilized form of the Spike (S) protein authorized for use in Japan on May 21, 2021.
Japan's Ministry of Health, Labour, and Welfare (MHLW) granted special approval under Article 14-3 of the Pharmaceuticals and Medical Devices Act for the emergency use of Moderna’s mRNA COVID-19 vaccine, which is authorized for emergency use in adults aged 18 years and older.
Japan's approval results from a three-way agreement announced in October 2020 with Moderna and the Government of Japan’s MHLW to distribute 50 million doses of TAK-919 in Japan in the first half of 2021.
The approval is based on Moderna’s Phase 3 COVE study results and positive initial clinical data from the Takeda-led placebo-controlled Phase 1/2 study. This study is designed to evaluate the safety and immunogenicity of two vaccinations of COVID-19 Vaccine Moderna Intramuscular Injection at the 100 μg dose level given 28 days apart in 200 participants aged 20 years and above in Japan. Initial results showed an immune response with results from Moderna’s Phase 3 COVE study conducted in the U.S. Binding and neutralizing antibody titers were elevated 28 days after the second dose of the Moderna COVID-19 vaccine candidate in 100% of participants. The vaccine candidate was generally well tolerated with no significant safety concerns reported. Participants will be followed through 12 months after the second vaccination.
Osaka-based Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Osaka, Japan, committed to discover and deliver life-transforming treatments, guided by their commitment to patients, their people, and the planet. For more information, visit www.TakedaVaccines.com.
COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919) Dosage
Based on the results of the Moderna study, the data indicate that a 100 mcg dose of vaccine is generally well-tolerated across age strata, with solicited symptoms mostly mild-to-moderate in severity and self-limited duration; and Induces neutralizing Abs in the upper half of the range of convalescent serum across age strata, with the induction of Th-1 biased, CD4+ T-cells. The 100 mcg dose was evaluated in the Phase 3 study.
The Package Insert is found at this link.
COVID-19 Vaccine Moderna Intramuscular Injection (TAK-919) News
May 23, 2021 - Japan's Defense Ministry confirmed it administered Moderna Inc.'s coronavirus vaccine among Self-Defense Forces members, the first confirmed use of the Moderna vaccine in Japan, reported Kyodo News.
May 21, 2021 - 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. Takeda plans to begin distribution in Japan immediately.
March 5, 2021 - Moderna announced that Takeda submitted a New Drug Application to the Government of Japan’s Ministry of Health, Labour, and Welfare to import and distribute Moderna’s vaccine candidate against COVID-19 (mRNA-1273 or TAK-919) in Japan.
February 4, 2021 - The NEJM published an ORIGINAL ARTICLE: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. CONCLUSION - The mRNA-1273 vaccine showed 94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local and systemic reactions, no safety concerns were identified.
October 29, 2020 - Takeda and Moderna announced that Takeda would import and distribute 50 million doses of Moderna’s COVID-19 vaccine candidate starting in the first half of 2021.
TAK-919 COVID-19 Vaccine Clinical Trials
Takeda continues to test TAK-919 in clinical trials.