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US FDA approves updated COVID vaccines for 2026-27 season
The updated shots target the XFG subvariant and are approved for adults 65 and older and younger people at high risk, Moderna said.
On Thursday, the U.S. Food and Drug Administration approved Moderna's updated Spikevax and mNEXSPIKE vaccines for the 2026-27 season, targeting the JN.1-lineage XFG subvariant of SARS-CoV-2.
Following an expert panel's May recommendation to prioritize the XFG variant, regulators also authorized updated COVID-19 vaccines from Pfizer-BioNTech and Novavax-Sanofi on the same day.
Moderna Chief Executive Officer Stéphane Bancel noted that COVID-19 caused up to 2.3 million outpatient visits last year. Updated Spikevax is approved for ages 6 months through 64 years with underlying conditions and all adults 65 and older.
Myocarditis and pericarditis have occurred most commonly in males 12 years through 24 years of age following mRNA vaccination. Recipients should seek immediate medical attention for chest pain or shortness of breath within 2 weeks of vaccination.
Beyond the United States, the Spikevax formula has already received regulatory approval in Europe, the United Kingdom, Switzerland, Singapore, and South Korea, with additional applications under review globally.