MRNA-1283

Last updated

mRNA-1283
Vaccine description
Target SARS-CoV-2
Vaccine type mRNA
Clinical data
Trade names mNEXSPIKE [1]
Routes of
administration 		Intramuscular

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]

Clinical Trial

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]

References

  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. 1 2 "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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