Health

FDA Approves Moderna's Next-Gen COVID Vaccine With Age Limits

Published MAY 31 2025

Story

Above: A vial of Moderna's COVID-19 vaccine. Image credit: Unsplash

The Facts

The U.S. Food and Drug Administration has approved Moderna's next-generation COVID-19 vaccine, mNEXSPIKE, specifically for adults aged 65 and older and individuals aged 12-64 years with underlying health conditions as defined by the Centers for Disease Control and Prevention.
Bloomberg.com
The Times of India
In clinical trials involving 11,400 participants, mNEXSPIKE demonstrated 9.3% higher relative vaccine efficacy compared to Moderna's original Spikevax vaccine in individuals aged 12 years and older, and 13.5% higher efficacy in those aged 65 years and older.
Axios
The Pharmaletter
Common side effects reported in clinical trials include injection site pain, fatigue, headache, and myalgia, with the vaccine showing a similar safety profile to previous versions but with fewer local reactions.
Investors
The Pharmaletter
Moderna plans to make mNEXSPIKE, which can be stored in standard refrigerators rather than freezers, available for the 2025-2026 respiratory virus season, alongside its existing products Spikevax and mRESVIA, its approved respiratory syncytial virus vaccine.
Investors
USA Today
The approval comes amid tightened FDA requirements, which now mandate drugmakers to test COVID-19 booster shots against placebos in healthy adults under 65, limiting their use to older adults and at-risk populations.
Reuters
CNN
This also comes as a new SARS-CoV-2 variant has caused COVID-19 surges and an increase in emergency room visits and hospitalizations in several Asian countries, including China and Hong Kong. The variant is also reportedly spreading in the U.S. and Europe.
The Times of India
South China Morning Post

Sources Split

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RIGHT

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The Spin

Narrative A

This is a crucial advancement in protecting vulnerable populations from COVID-19, which remains a significant public health threat, having claimed 47,000 American lives last year alone. The vaccine's superior efficacy and improved storage capabilities make it a more practical and effective tool for healthcare providers. The targeted approach ensures those most at risk receive optimal protection while maintaining high safety standards.

Investors

Axios

Narrative B

The restricted approval reflects a concerning shift in vaccine policy under new leadership, potentially limiting access to preventive care for broader populations. The more stringent requirements for vaccine testing and narrower eligibility criteria could hinder public health efforts and create unnecessary barriers to vaccination, especially for younger, healthy individuals who may benefit from continued protection.

Scientific American

Bloomberg.com