FDA Approves Moderna’s COVID-19 Vaccine

The federal agency has given the nod to the latest Moderna COVID-19 vaccine mRNA-1283 (mNEXSPIKE). This becomes the first vaccine approved under the new federal guidelines that change who is eligible for the immunizations. The vaccine is indicated for use in all adults 65 and older, as well as individuals aged 12-64 years with at least 1 or more underlying risk factor as defined by the Centers for Disease Control and Prevention (CDC).

"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," Moderna CEO Stéphane Bancel, said in a statement. ¹ "COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone."

Phase 3 Data

The new approval is based on results from a randomized, observer-blind, active-controlled phase 3 clinical trial, which enrolled approximately 11,400 participants aged 12 years and older. The primary efficacy objective in this study was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNEXSPIKE compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna's original COVID-19 vaccine.

Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273. mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.

In this trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions. The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.

Moderna said it expects to have the mRNA-1283 vaccine ready in the US for the 2025-2026 respiratory virus season. Additionally, the vaccine is under review with regulators in multiple markets around the world.

New Federal COVID-19 Vaccine Guidelines

Earlier this week, the leaders of the NIH, HHS, and FDA, announced the removal of the COVID-19 vaccine from the immunization schedule for pregnant women and healthy children in a social media post.

However, since that post, the federal government has yet again changed its stance on the vaccine and healthy children. In fact on the CDC's Child and Adolescent Immunization Schedule by Age, the COVID-19 vaccines will be available to the pediatric population under what is Shared clinical decision-making in the guidance. This addresses children ages 6 months –17 years who are not moderately or severely immunocompromised, and it says the following: "Shared clinical decision-making vaccinations are individually based and informed by a decision process between the health care provider and the patient or parent/guardian. Where the parent presents with a desire for their child to be vaccinated, children 6 months and older may receive COVID-19 vaccination, informed by the clinical judgment of a healthcare provider and personal preference and circumstances," the CDC says on the website.

References
1. Moderna Receives U.S. FDA Approval for COVID-19 Vaccine mNEXSPIKE. Moderna press release. May 31, 2025. Accessed May 31, 2025.
https://investors.modernatx.com/news/news-details/2025/Moderna-Receives-U-S--FDA-Approval-for-COVID-19-Vaccine-mNEXSPIKE/default.aspx
2.Prasad V, Makary MA. An Evidence-Based Approach to Covid-19 Vaccination. N Engl J Med. Published online May 20, 2025. doi:10.1056/NEJMsb2506929