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MRNA-1283

Antiinfective Agents for Systemic Use

mRNA-1283, sold under the brand name mNEXSPIKE, is a COVID-19 vaccine developed by Moderna. Compared with earlier mRNA vaccines it is designed for storage at 2 to 5 degrees Celsius, which suits an ordinary refrigerator instead of a low temperature freezer, and it is packaged in prefilled syringes, which is meant to reduce the burden on healthcare workers and widen access. A clinical trial to evaluate its immune response and safety began in December, and by May 2024 the candidate was in Phase 3 trials. Preliminary results showed a strong immune response, especially in people over 65, who are at greater risk of severe COVID-19. The United States Food and Drug Administration approved it on May 30, 2025 under the name mNEXSPIKE for adults aged 65 or older and for people aged 12 to 64 with at least one comorbidity.

Facts
Classification
Approval Status
Approved 1
ATC Class
J: Antiinfectives for Systemic Use 1
First Approved / Isolated Year
2025 1
Sources
1. MRNA-1283 (Wikipedia)
  • Lead
    a COVID-19 vaccine candidate developed by Moderna
  • Clinical Trial
    approved by the Food and Drug Administration on May 30, 2025
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