Spikevax and mNEXSPIKE authorized for older adults and high-risk individuals; experts emphasize protection against severe COVID-19 outcomes.
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.
To provide further insight into the FDA authorization and what it means for high-risk populations, we conducted a Q&A via email with Moderna. The discussion focused on the durability of protection against emerging variants, vaccine performance in older adults and those with underlying health conditions, and efforts to ensure equitable access for vulnerable groups.
Moderna: Moderna performs ongoing strain monitoring, and is equipped to rapidly assess new variants to determine how new antigenic changes could impact cross-neutralization from approved strain compositions. All currently circulating strains are in the same lineage as LP.8.1, and our risk assessment demonstrates that the LP.8.1 vaccine remains well-matched. Clinical data are coming soon and are expected to confirm these preliminary results.
Moderna: "Moderna will perform real-world effectiveness assessments of the updated LP.8.1 vaccine composition. To date, however, each new variant vaccine composition, including last year’s KP.2 vaccine composition, has demonstrated significant benefit in prevention of hospitalizations and severe outcomes."
Moderna: "Insurance coverage for COVID-19 vaccines varies by plan. We recommend checking directly with your insurance provider about current coverage and documentation requirements or consulting your healthcare provider about payment options and assistance programs for uninsured individuals."
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.
