Moderna Japan Receives Manufacturing and Marketing Approval for COVID-19 Vaccine "Mnuvax® Intramuscular Injection Syringe for Individuals 12 Years and Older"
Moderna Japan has received manufacturing and marketing approval in Japan for its new COVID-19 vaccine, "Mnuvax® Intramuscular Injection Syringe for individuals 12 years and older." The vaccine contains 10μg of mRNA, which is 1/5 the amount of the conventional vaccine, and its safety and immunogenicity have been confirmed in domestic trials. The company aims to begin supply around the autumn of 2026.
📋 Article Processing Timeline
- 📰 Published: May 19, 2026 at 02:00
- 🔍 Collected: May 20, 2026 at 11:01 (33h 1m after Published)
- 🤖 AI Analyzed: May 22, 2026 at 04:14 (41h 12m after Collected)
## Moderna Japan Receives Manufacturing and Marketing Approval for COVID-19 Vaccine "Mnuvax® Intramuscular Injection Syringe for Individuals 12 Years and Older"
Moderna Japan K.K. (Minato-ku, Tokyo; hereinafter "Moderna Japan") announced that it has received manufacturing and marketing approval in Japan for the "Mnuvax® Intramuscular Injection Syringe for individuals 12 years and older" (hereinafter "the drug") for the prevention of infectious diseases caused by SARS-CoV-2.
The drug is administered in a single dose of 0.2mL and contains 10μg of mRNA, which is equivalent to 1/5 of the mRNA contained in the "Spikevax® Intramuscular Injection Syringe for individuals 12 years and older." Approval was granted based on immunogenicity and safety evaluated in a domestic Phase III clinical trial in Japan (mRNA-1283 P301 Japanese cohort)※1.
This mRNA vaccine was launched in the U.S. in 2025 and has already been approved by regulatory authorities in the EU, Canada, and Australia, and the company continues to aim for global deployment.
Moderna Japan is preparing, in collaboration with relevant parties, to begin supply of the drug around the autumn of 2026 as a new option for COVID-19 vaccination for the people of Japan.
Reference:
※1. Grassi CM, et al.: Vaccine 2026; 69: 127960
## About Moderna
Moderna is an innovative leader in the field of mRNA medicine. Through advances in mRNA technology, Moderna has fundamentally changed the way medicines are manufactured and continues to transform approaches to disease treatment and prevention. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across a wide range of areas, including infectious diseases, cancer, and rare diseases.
Employees worldwide, sharing a unique corporate culture, values, and mindset, work together to contribute to human health and strive to bring maximum impact to people through mRNA medicine.
Moderna Japan K.K. (Minato-ku, Tokyo; hereinafter "Moderna Japan") announced that it has received manufacturing and marketing approval in Japan for the "Mnuvax® Intramuscular Injection Syringe for individuals 12 years and older" (hereinafter "the drug") for the prevention of infectious diseases caused by SARS-CoV-2.
The drug is administered in a single dose of 0.2mL and contains 10μg of mRNA, which is equivalent to 1/5 of the mRNA contained in the "Spikevax® Intramuscular Injection Syringe for individuals 12 years and older." Approval was granted based on immunogenicity and safety evaluated in a domestic Phase III clinical trial in Japan (mRNA-1283 P301 Japanese cohort)※1.
This mRNA vaccine was launched in the U.S. in 2025 and has already been approved by regulatory authorities in the EU, Canada, and Australia, and the company continues to aim for global deployment.
Moderna Japan is preparing, in collaboration with relevant parties, to begin supply of the drug around the autumn of 2026 as a new option for COVID-19 vaccination for the people of Japan.
Reference:
※1. Grassi CM, et al.: Vaccine 2026; 69: 127960
## About Moderna
Moderna is an innovative leader in the field of mRNA medicine. Through advances in mRNA technology, Moderna has fundamentally changed the way medicines are manufactured and continues to transform approaches to disease treatment and prevention. Since its founding, Moderna's mRNA platform has enabled the development of vaccines and therapeutics across a wide range of areas, including infectious diseases, cancer, and rare diseases.
Employees worldwide, sharing a unique corporate culture, values, and mindset, work together to contribute to human health and strive to bring maximum impact to people through mRNA medicine.
FAQ
モデルナ・ジャパンが日本で承認を取得した新しい新型コロナワクチンは何ですか？
「エムネクスパイク®筋注シリンジ 12歳以上用」です。
エムネクスパイク®の有効成分量はどのくらいですか？
1回0.2mLの接種用量で、10μgのmRNAを含有しています。これは「スパイクバックス®筋注シリンジ12歳以上用」の1/5に相当します。
エムネクスパイク®の供給開始はいつ頃を予定していますか？
2026年秋頃の供給開始を目指して準備が進められています。
本剤の有効性と安全性はどう評価されましたか？
日本人を対象とした国内第Ⅲ相試験（mRNA-1283 P301試験日本コホート）において評価されました。
エムネクスパイク®は日本以外でも承認されていますか？
はい、2025年に米国で上市されており、EU、カナダ、オーストラリアでも既に承認を取得しています。