Next-Generation Moderna COVID-19 Vaccine Approved in the U.S.

The U.S. Food and Drug Administration (FDA) has approved Moderna’s next-generation COVID-19 vaccine for everyone aged 65 and older, Reuters reports, citing a company statement.

The vaccine has also been approved for individuals aged 12 to 64 who have one or more underlying risk factors, according to Moderna’s announcement.

Moderna stated that it expects the vaccine, named *mNEXSPIKE*, to be available for the 2025–2026 respiratory virus season.

“The FDA approval of our third product, mNEXSPIKE, adds an important new tool to help protect those at high risk of severe disease from COVID-19,” said CEO Stéphane Bancel in a statement. The U.S. Department of Health and Human Services is increasing regulatory oversight of vaccines.

The Moderna vaccine, marketed as *mNEXSPIKE*, can be stored in refrigerators rather than freezers, allowing for a longer shelf life and easier distribution—particularly in developing countries, where supply chain issues can hinder vaccination efforts.

On May 20, the FDA announced plans to require drug manufacturers to test their COVID-19 vaccines against an inert placebo in healthy adults under 65 to gain approval, effectively limiting their use to older adults and those at risk of severe illness.

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