Spikevax and mNEXSPIKE authorized for older adults and high-risk individuals; experts emphasize protection against severe COVID-19 outcomes.
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Image credits: Moderna
Image credits: Moderna
Image credits: Moderna
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax® and mNEXSPIKE®, for the 2025–2026 respiratory virus season. The authorization, announced August 27, 2025, allows the vaccines to target the LP.8.1 variant of SARS-CoV-2.
Spikevax is indicated for individuals aged 6 months through 64 years with at least one underlying condition associated with severe COVID-19, as well as all adults ≥65 years. mNEXSPIKE is approved for individuals aged 12 through 64 with at least one high-risk condition, in addition to adults ≥65 years. Moderna expects the updated vaccines to be available in the US within days.
According to Moderna, COVID-19 was responsible for up to 4 million outpatient visits and nearly 500,000 hospitalizations in the United States last year. The FDA based its vaccine composition guidance on a monovalent JN.1 lineage, with preference for the LP.8.1 variant.
FDA approved Moderna’s updated COVID-19 vaccines Spikevax and mNEXSPIKE on August 27, 2025, targeting the LP.8.1 variant.
Spikevax: authorized for ≥65 years and 6 months–64 years with high-risk conditions; mNEXSPIKE: authorized for ≥65 years and 12–64 years with high-risk conditions.
COVID-19 caused up to 500,000 hospitalizations in the US last year; experts call updated vaccines the best protection for older and immunocompromised patients.
“The updated COVID-19 vaccine directly addresses current variants and provides the most updated protection for those who need it most,” said Camille Vaughan, MD, MS, professor and division director in the Emory University Department of Medicine, Division of Geriatrics and Gerontology. “For my older and immunocompromised patients, it’s our best tool to stay healthy and avoid complications—so they can focus on what matters most.”
The updated vaccines have also received regulatory approvals in Canada, Europe, Japan, and Switzerland, with additional applications under review globally.
Spikevax and mNEXSPIKE carry risks of rare adverse events, including myocarditis and pericarditis, most often observed in males aged 12–24 years. Common side effects reported in clinical trials include injection site pain, fatigue, headache, myalgia, chills, and fever. Severe allergic reactions, though rare, may occur shortly after vaccination.
The FDA emphasized that vaccination may not fully protect all recipients, and patients are encouraged to consult their healthcare providers to assess risks and benefits.
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