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mRNA-1283 - Wikipedia

From Wikipedia, the free encyclopedia

Vaccine candidate against COVID-19

Pharmaceutical compound

mRNA-1283, sold under the brand name mNEXSPIKE, is a COVID-19 vaccine candidate developed by Moderna.[2][3][4]

Compared to prior mRNA vaccines, this candidate has a storage temperature of 2-5 °C, compatible with vaccine storage in a standard refrigerator, rather than low temperature freezers.[5] Additionally, the vaccine will be packaged in prefilled syringes, reducing burden on healthcare workers and potentially increasing access.[6]

In December, Moderna started a clinical trial which would evaluate the vaccine's ability to provoke an immune response and its safety.[7] As of May 2024, the vaccine candidate is in Phase 3 clinical trials, with an estimated completion date of late August 2024.[8] Preliminary results from this trial indicated the vaccine produced a strong immune response, especially in patients over 65, who are at greater risk for severe outcomes from COVID-19.[9]

mRNA-1283 was approved by the Food and Drug Administration on May 30, 2025, under the name "mNEXSPIKE", for use in adults 65 years or older and individuals 12-64 years old with at least one comorbidity.[10][4][11]

  1. ^ "Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it". CBS News. 31 May 2025. Retrieved 26 June 2025.
  2. ^ "A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19". ClinicalTrials.gov. 24 March 2021. NCT04813796. Retrieved 17 August 2021.
  3. ^ "A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters". ClinicalTrials.gov. 30 November 2021. NCT05137236. Retrieved 30 November 2021.
  4. ^ a b "Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it". CBS News. 31 May 2025. Archived from the original on 26 June 2025. Retrieved 26 June 2025.
  5. ^ "Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine". news.modernatx.com. Retrieved 30 May 2024.
  6. ^ "Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine". news.modernatx.com. Retrieved 30 May 2024.
  7. ^ Yassini P, Hutchens M, Paila YD, Schoch L, Aunins A, Siangphoe U, Paris R (December 2023). "Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults". Human Vaccines & Immunotherapeutics. 19 (1): 2190690. doi:10.1080/21645515.2023.2190690. PMC 10128428. PMID 37074202.
  8. ^ "A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE)". ClinicalTrials.org. Retrieved 30 May 2024.
  9. ^ "Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine". news.modernatx.com. Retrieved 30 May 2024.
  10. ^ Kaslow DC (30 May 2025). "May 30, 2025 Approval Letter - MNEXSPIKE". Food and Drug Administration. Archived from the original on 12 June 2025. Retrieved 26 June 2025.
  11. ^ Greenfield B (2 June 2025). "What you need to know about Moderna's new COVID vaccine, just approved by the FDA". Fortune Well. Archived from the original on 26 June 2025. Retrieved 26 June 2025.
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