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.
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- Source: PR TIMES
- Category: New Product