FDA Approves New Moderna Jab

The Food and Drug Administration (FDA) has approved Moderna’s ‘next-generation COVID-19 vaccine’ for adults 65 and older and individuals 12 to 64 with at least one underlying condition.

“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.

“COVID-19 remains a serious public health threat, with more than 47,000 Americans dying from the virus last year alone. We appreciate the FDA’s timely review and thank the entire Moderna team for their hard work and continued commitment to public health,” he added.

We announced today that the U.S. FDA has approved mNEXSPIKE®, a new vaccine against COVID-19, for use in all adults 65 and older, as well as individuals aged 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes… pic.twitter.com/RJ1CezICKZ

— Moderna (@moderna_tx) May 31, 2025

Per Moderna:

The FDA’s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 clinical trial (ClinicalTrials.gov Identifier: NCT05815498), 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 the Phase 3 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 expects to have mNEXSPIKE available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA®, the Company’s approved respiratory syncytial virus (RSV) vaccine.

mRNA-1283 is under review with regulators in multiple markets around the world.

FDA approves Moderna’s next-generation COVID vaccine for adults 65 or older https://t.co/TaaVk1vCN0 pic.twitter.com/1SdxmmmZbe

— New York Post (@nypost) May 31, 2025

From the New York Post:

The FDA said on May 20 it planned to require drugmakers to test their COVID booster shots against an inert placebo in healthy adults under 65 for approval, effectively limiting them to older adults and those at risk of developing severe illness.

The Moderna vaccine can be stored in refrigerators rather than freezers, to offer longer shelf life and make distribution easier, especially in developing countries where supply-chain issues could hamper vaccination drives.

The Centers for Disease Control and Prevention, which Kennedy also oversees, said on Thursday that COVID vaccines remain an option for healthy children when parents and doctors agree that it is needed, stopping short of Kennedy’s announcement days earlier that the agency would remove the shots from its immunization schedule.

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The CDC announcement eases investor concern to some extent, analysts say, as it keeps the existing framework for older adults and at-risk people who generally seek out the shots.

FDA leaders have said 100 million to 200 million Americans would still be eligible for annual shots.

Moderna is betting on its newer messenger RNA vaccines as it grapples with waning demand for its original COVID vaccine Spikevax and lower-than-expected uptake of its respiratory syncytial virus vaccine.