FDA Approves mRNA-1283 COVID-19 Vaccine for Adults 65 and Older, Those With Underlying Conditions

Key Takeaways

mRNA-1283 vaccine shows higher efficacy than mRNA-1273, with 9.3% higher rVE in individuals 12+ and 13.5% in those 65+.
The vaccine demonstrated strong immunogenicity against Omicron BA.4/5 and ancestral SARS-CoV-2, with a positive safety profile.
FDA's new framework prioritizes COVID-19 vaccines for adults 65+ and high-risk individuals, aligning with recent approvals.
Pharmacists remain essential in distributing updated vaccines for the 2025-2026 respiratory season amid evolving guidance.

Amid intensified scrutiny of COVID-19 vaccines at HHS, Moderna’s mRNA-1283 COVID-19 vaccine was granted FDA approval for patients 65 years and older and patients aged 12 to 64 years with at least 1 or more underlying risk factors for severe COVID-19.

mRNA-1283 (mNEXSPIKE; Moderna), a vaccine designed to protect against COVID-19, was granted FDA approval for use in all adults 65 years and older and individuals aged 12 to 64 years with at least 1 or more underlying risk factors for serious COVID-19 as defined by the CDC, according to a news release from Moderna.¹

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Moderna's COVID-19 vaccine utilizes mRNA technology. | Image Credit: © Stimmungsbilder1 - stock.adobe.com

Positive Data Indicate Effectiveness of mRNA-1283 Compared With Predecessor

In a phase 3 randomized, observer-blind, active-controlled study (NCT05815498), mRNA-1283 demonstrated noninferior vaccine efficacy against COVID-19 compared with mRNA-1273 (Spikevax; Moderna), the original mRNA-based COVID-19 vaccine developed by Moderna. In the trial, which enrolled approximately 11,400 individuals 12 years and older, higher efficacy was demonstrated among adults 18 years and older with mRNA-1283 compared with mRNA-1273, with consistent efficacy trends observed in adults 65 years and older.^2,3

Specifically, regarding the primary end point of relative vaccine efficacy (rVE), mRNA-1283 indicated a 9.3% higher rVE compared with mRNA-1273 in individuals 12 years and older. Furthermore, in a descriptive subgroup analysis, a 13.5% higher rVE in adults 65 years and older was found with mRNA-1283 compared with mRNA-1273.¹

About the Trial

Trial Name: A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE)

ClinicalTrials.gov: NCT05815498

Sponsor: ModernaTX, Inc.

Completion Date: April 12, 2025

Previously announced immunogenicity results from the trial indicated higher neutralizing antibody responses with mRNA-1283 against both Omicron BA.4/5 and the ancestral SARS-CoV-2 variant compared with mRNA-1273. The highest geometric mean titer ratios were observed in adults and those 65 years and older, according to the investigators. Critically, mRNA-1283 was found to have a similarly positive safety profile to mRNA-1273, with the most solicited adverse effects including fatigue, injection site pain, and headache.²

"The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect people at high risk of severe disease from COVID-19," Stéphane Bancel, CEO of Moderna, said in the news release. “COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone.”¹

mRNA-1283 in the Context of Updated FDA COVID-19 Vaccine Guidance

The FDA’s approval of mRNA-1283 becomes the second COVID-19 vaccine granted regulatory clearance under a new framework recently announced by FDA Commissioner Martin A. Makary, MD, MPH; and Director of the Center for Biologics Evaluation and Research Vinay Prasad, MD, MPH. The framework details a major shift, with the FDA now prioritizing COVID-19 vaccine recommendations for adults 65 years and older and individuals with 1 or more risk factors for severe disease. Last month, Novavax’s COVID-19 vaccine Nuvaxoid was approved under the same parameters as mRNA-1283.^4,5

Correspondingly, Robert F. Kennedy Jr, secretary of the Department of Health and Human Services (HHS), announced that the CDC will be altering its COVID-19 vaccine guidance, no longer recommending that healthy children and pregnant individuals receive routine vaccinations. However, in the days since that announcement, the CDC has updated its Child and Adolescent Immunization Schedule, noting that “shared clinical decision-making” between a health care provider and patient would allow a healthy child aged 6 months to 17 years to receive a COVID-19 vaccine, contrasting with Kennedy’s announcement.^6-8

With conflicting COVID-19 vaccine guidance abounding, it remains imperative that pharmacists stay aware and keep themselves updated regarding changes in recommendations or vaccine availability. Despite the litany of changes to the COVID-19 vaccine recommendation process since Kennedy took over leadership, updated vaccines are poised to be available to at least a large portion of the US population this upcoming respiratory season. Pharmacists will remain indispensable members of the health care community in the effort to vaccinate eligible patients with COVID-19 vaccinations in time for the 2025-2026 respiratory season.¹

REFERENCES

1. Moderna. Moderna receives U.S. FDA approval for COVID-19 vaccine mNEXSPIKE. News Release. Released May 31, 2025. Accessed June 2, 2025. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx

2. Moderna. Moderna announces positive phase 3 efficacy data for mRNA-1283, the company’s next generation COVID-19 vaccine. News Release. Released June 13, 2024. Accessed June 2, 2025. https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Positive-Phase-3-Efficacy-Data-for-mRNA-1283-the-Companys-Next-Generation-COVID-19-Vaccine/default.aspx

3. ClinicalTrials.gov. A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19 (NextCOVE). National Library of Medicine. Last Updated May 7, 2025. Accessed June 2, 2025. https://clinicaltrials.gov/study/NCT05815498?term=NCT05815498&rank=1

4. Halpern L. FDA to restrict future COVID-19 vaccine recommendations to older adults, high-risk groups. Pharmacy Times. Published May 21, 2025. Accessed June 2, 2025. https://www.pharmacytimes.com/view/fda-to-restrict-future-covid-19-vaccine-recommendations-to-older-adults-high-risk-groups

5. Halpern L. FDA approves Novavax COVID-19 vaccine for patients 65 years and older, those with underlying conditions. Pharmacy Times. Published May 19, 2025. Accessed June 2, 2025. https://www.pharmacytimes.com/view/fda-approves-novavax-covid-19-vaccine-for-patients-65-years-and-older-those-with-underlying-conditions

6. Halpern L. CDC to end COVID-19 vaccine recommendation for healthy children, pregnant women. Pharmacy Times. Published May 27, 2025. Accessed June 2, 2025. https://www.pharmacytimes.com/view/cdc-to-end-covid-19-vaccine-recommendation-for-healthy-children-pregnant-women

7. Jewett C. C.D.C. contradicts Kennedy and keeps advice that children may get Covid shots. The New York Times. Updated May 30, 2025. Accessed June 2, 2025. https://www.nytimes.com/2025/05/30/health/cdc-covid-vaccines-children-pregnant-women.html

8. CDC. Vaccines & immunizations – Child immunization schedule notes. Updated May 29, 2025. Accessed June 2, 2025. https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-notes.html#note-covid-19