mRNA-1283

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{{short description|Vaccine candidate against COVID-19}}

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| drug_name = mRNA-1283

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| type = vaccine

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| target = SARS-CoV-2

| vaccine_type = mrna

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| tradename = mNEXSPIKE{{cite web |title=Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it|url=https://www.cbsnews.com/news/mnexspike-moderana-new-covid-vaccine/ |access-date=26 June 2025 |publisher=CBS News |date=31 May 2025}}

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| routes_of_administration = Intramuscular

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{{COVID-19 pandemic sidebar}}

mRNA-1283, sold under the brand name mNEXSPIKE, is a COVID-19 vaccine candidate developed by Moderna.{{Cite web|title=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 |url=https://clinicaltrials.gov/ct2/show/NCT04813796 |website=ClinicalTrials.gov |date=24 March 2021 |id=NCT04813796 |access-date=17 August 2021 }}{{Cite web|title=A Study to Evaluate the Immunogenicity and Safety of mRNA-1283 COVID-19 Vaccine Boosters |url=https://clinicaltrials.gov/ct2/show/NCT05137236 |website=ClinicalTrials.gov |date=30 November 2021 |id=NCT05137236 |access-date=30 November 2021 }}{{Cite web |date=2025-05-31 |title=Moderna's new COVID-19 vaccine mNexspike approved by FDA, but there's a limit on who can use it |url=https://www.cbsnews.com/news/mnexspike-moderana-new-covid-vaccine/ |url-status=live |archive-url=https://web.archive.org/web/20250626182505/https://www.cbsnews.com/news/mnexspike-moderana-new-covid-vaccine/ |archive-date=2025-06-26 |access-date=2025-06-26 |website=CBS News |language=en-US}}

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.{{cite web |title=Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine | url=https://news.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx|website=news.modernatx.com|access-date=30 May 2024}} Additionally, the vaccine will be packaged in prefilled syringes, reducing burden on healthcare workers and potentially increasing access.{{cite web |title=Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine | url=https://news.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx|website=news.modernatx.com|access-date=30 May 2024}}

Clinical Trial

In December, Moderna started a clinical trial which would evaluate the vaccine's ability to provoke an immune response and its safety.{{cite journal | vauthors = Yassini P, Hutchens M, Paila YD, Schoch L, Aunins A, Siangphoe U, Paris R | title = Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults | journal = Human Vaccines & Immunotherapeutics | volume = 19 | issue = 1 | pages = 2190690 | date = December 2023 | pmid = 37074202 | pmc = 10128428 | doi = 10.1080/21645515.2023.2190690 }} As of May 2024, the vaccine candidate is in Phase 3 clinical trials, with an estimated completion date of late August 2024.{{cite web |title=A Study of mRNA-1283.222 Injection Compared With mRNA-1273.222 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE) |url=https://www.clinicaltrials.gov/study/NCT05815498 |website=ClinicalTrials.org |access-date=30 May 2024}} 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.{{cite web |title=Moderna Achieves Positive Interim Results from Phase 3 Trial of Next-Generation COVID-19 Vaccine | url=https://news.modernatx.com/news/news-details/2024/Moderna-Achieves-Positive-Interim-Results-from-Phase-3-Trial-of-Next-Generation-COVID-19-Vaccine/default.aspx|website=news.modernatx.com|access-date=30 May 2024}}

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.{{Cite web |last=Kaslow |first=David C. |date=2025-05-30 |title=May 30, 2025 Approval Letter - MNEXSPIKE |url=https://www.fda.gov/media/186740/download?attachment |url-status=live |archive-url=https://web.archive.org/web/20250612192708/https://www.fda.gov/media/186740/download?attachment |archive-date=2025-06-12 |access-date=2025-06-26 |website=Food and Drug Administration}}{{Cite web |last=Greenfield |first=Beth |date=2025-06-02 |title=What you need to know about Moderna's new COVID vaccine, just approved by the FDA |url=https://fortune.com/well/2025/06/02/moderna-new-covid-vaccine-approved-by-fda-what-to-know/ |url-status=live |archive-url=https://web.archive.org/web/20250626182643/https://fortune.com/well/2025/06/02/moderna-new-covid-vaccine-approved-by-fda-what-to-know/ |archive-date=2025-06-26 |access-date=2025-06-26 |website=Fortune Well |language=en}}

References

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Category:Clinical trials related to COVID-19

Category:American COVID-19 vaccines

Category:RNA vaccines

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