
FDA approves Moderna’s updated COVID-19 vaccines targeting new variant
Ella Day | September 1, 2025 | News story | | FDA
The US Food and Drug Administration (FDA) has approved Moderna’s updated COVID-19 vaccines, Spikevax and mNEXSPIKE, intended to target the LP.8.1 variant of SARS-CoV-2.
The decision means that the 2025-26 formulas will soon be made available across the US. Spikevax is now authorised for adults aged 65 and over, and for people aged six months to 64 years with underlying health conditions that increase their risk of severe COVID-19. mNEXSPIKE, Moderna’s newly developed vaccine is approved for adults aged 65 and over and for those aged 12 to 64 with high-risk health conditions.
The FDA’s guidance called for updated vaccines to be based on the JN.1 lineage, with a preference for the LP.8.1 strain, which is currently circulating.
“Protecting people at increased risk of severe outcomes from COVID-19 is imperative to public health,” said chief executive officer Stéphane Bancel.
Moderna helped pioneer mRNA vaccine technology during the COVID-19 pandemic. The updated vaccines have already been approved by regulators in Europe, Canada, Japan and Switzerland, among others. Further applications are under review worldwide.
Ella Day
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