FDA Grants Full Approval to mRNA-1273 COVID-19 Vaccine in Children At Increased Risk

The FDA has approved the supplemental biologics application for mRNA-1273 (Spikevax; Moderna), a COVID-19 vaccine using a 2024-2025 formula, in children aged 6 months through 11 years who are at heightened risk for COVID-19 disease, according to a news release from Moderna.¹

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"COVID-19 continues to pose a significant potential threat to children, especially those with underlying medical conditions. Vaccination can be an important tool for protecting our youngest against severe disease and hospitalization," Stéphane Bancel, CEO of Moderna, said in a news release. "We appreciate the FDA's diligent scientific review and approval of [mRNA-1273] for pediatric populations at increased risk for COVID-19 disease."¹

The vaccine was previously made available for this population under FDA emergency use authorization but has now received full approval by the agency, with Moderna expecting to have the updated vaccine ready for its indicated populations in the US for the 2025-2026 respiratory season. With this new indication, mRNA-1273 is now approved for all adults aged 65 years and older and those aged 6 months through 64 years at increased disease risk.¹

Clinical Efficacy and Comparisons With mRNA-1283

mRNA-1273 has been Moderna’s flagship COVID-19 vaccine, being continuously updated to protect against currently circulating variants. The vaccine and its original formula were initially approved in 2022. The COVE clinical trial, which enrolled over 30,000 volunteers aged 18 years and older, solidified the efficacy of mRNA-1273, with vaccine efficacy measured at 94.1% (95% CI, 89.3%–96.8%; P < .001), including against severe disease.^2,3

Furthermore, trial data among children aged 6 months to 5 years further indicates the efficacy of mRNA-1273. In the KidCOVE trial, two 25-μg doses of mRNA-1273 were found to be safe and elicit immune responses that were noninferior to those in young adults.⁴

Moderna’s next-generation COVID-19 vaccine, mRNA-1283 (mNEXSPIKE), was granted FDA approval for all adults aged 65 years and older and individuals aged 12 to 64 years with at least 1 or more underlying risk factors for serious disease. Critically, a phase 3 trial (NextCOVE) comparing mRNA-1283 with mRNA-1273 found higher efficacy among adults aged 18 years and older with the next-generation mNEXSPIKE compared with Spikevax, with consistent efficacy demonstrated in older adults.⁵

For the 2025-2026 respiratory season, Moderna intends to have available both mRNA-1283 and mRNA-1273 for patients to protect themselves against COVID-19.¹

Considerations for Providers

Pharmacists will now have another COVID-19 vaccine option to present to patients who are looking to protect themselves in the upcoming respiratory season. With proven efficacy and safety for both mRNA-1273 and mRNA-1283, patients may have questions regarding which vaccine may be best for them; pharmacists are in a prime position to provide the up-to-date, fact-based information patients want and need.

Which vaccine is best for a patient will likely come down to indication and risk factors. The new indication for mRNA-1273 will give parents with young children at high risk of disease an option for protection, while mRNA-1283 is not indicated for that population. However, for individuals aged 12 years and older with risk factors for severe disease, mRNA-1283 may be a more effective option given the clinical trial data garnered in NextCOVE. With both vaccines eliciting similar rates of adverse events, safety should not be a concern for patients for either vaccine candidate.^1,5

Risk factors that a patient harbors will also be of the utmost importance. Especially with the recent approval of mRNA-1283—approved under the context of new FDA guidance restricting future COVID-19 vaccine approvals for older adults and high-risk groups—knowing whether a patient has any features putting them at risk for severe disease will be critical for determining their vaccination plan.⁶

A decision on which vaccine to use may ultimately come down to availability. However, patients can be assured that whichever COVID-19 vaccine from Moderna they use, it will be safe and effective for the prevention of severe COVID-19 disease.

REFERENCES

1. Moderna. Moderna receives full US FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease. News Release. Released July 10, 2025. Accessed July 10, 2025. https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-Full-U-S--FDA-Approval-for-COVID-19-Vaccine-Spikevax-in-Children-Aged-6-Months-Through-11-Years-at-Increased-Risk-for-COVID-19-Disease/default.aspx

2. Moderna. Spikevax (COVID-19 vaccine, mRNA, 2024-2025 formula). Prescribing information. Updated July 10, 2025. Accessed July 10, 2025. https://static.modernatx.com/pm/6cef78f8-8dad-4fc9-83d5-d2fbb7cff867/5efa7d9d-05e8-46b5-945a-637c2867bd00/5efa7d9d-05e8-46b5-945a-637c2867bd00_viewable_rendition__v.pdf

3. Baden LR, Sahly HME, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403-416. doi:10.1056/NEJMoa2035389

4. Anderson EJ, Creech CB, Berthaud V, et al. Evaluation of mRNA-1273 vaccine in children 6 months to 5 years of age. N Engl J Med. 2022;387(18):1673-1687. doi:10.1056/NEJMoa220936

5. Halpern L. FDA approves mRNA-1283 COVID-19 vaccine for adults 65 years and older, those with underlying conditions. Pharmacy Times. Published June 2, 2025. Accessed July 10, 2025. https://www.pharmacytimes.com/view/fda-approves-mrna-1283-covid-19-vaccine-for-adults-65-and-older-those-with-underlying-conditions

6. Halpern L. FDA to restrict future COVID-19 vaccine recommendations to older adults, high-risk groups. Pharmacy Times. Published May 21, 2025. Accessed July 10, 2025. https://www.pharmacytimes.com/view/fda-to-restrict-future-covid-19-vaccine-recommendations-to-older-adults-high-risk-groups