Takeda Announces Approval of Moderna’s COVID-19 Vaccine in Japan

Rhea-AI Summary

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) received emergency use approval from Japan's Ministry of Health for Moderna's mRNA COVID-19 vaccine, now named COVID-19 Vaccine Moderna Intramuscular Injection. This decision is based on successful Phase 1/2 clinical trial results showing robust immune responses. Following a collaboration with Moderna, Takeda will distribute 50 million vaccine doses in Japan. The positive interim analysis indicated 100% antibody response in vaccinated participants, with no significant safety concerns. Distribution begins immediately.

Positive

• Received emergency use approval for COVID-19 Vaccine Moderna from Japan's Ministry of Health.
• Phase 1/2 clinical trials demonstrated 100% immune response with no significant safety concerns.
• Plans to distribute 50 million doses in Japan, reinforcing pandemic response efforts.

Negative

• None.

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 agre

FAQ

What is the recent news about Takeda (TAK) regarding COVID-19 vaccination in Japan?

Takeda has received emergency use approval from Japan's Ministry of Health for Moderna's COVID-19 Vaccine Moderna, allowing the distribution of 50 million doses.

What were the results of Takeda's clinical trials for the COVID-19 vaccine?

The interim analysis of Takeda's Phase 1/2 trials showed a 100% immune response with no significant safety issues reported.

How many doses of the COVID-19 vaccine will Takeda distribute in Japan?

Takeda plans to distribute 50 million doses of the COVID-19 Vaccine Moderna in Japan.

What is the stock symbol for Takeda Pharmaceutical Company?

The stock symbol for Takeda Pharmaceutical Company is TAK on the NYSE.