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In the fall of 2023, the US Food and Drug Administration (FDA) authorised the use of the updated Moderna (Sept 11), Pfizer-BioNTech (Sept 11), and Novavax (Oct 3) COVID-19 vaccines containing a monovalent component of the XBB. 1.5 variant “to provide better protection against serious consequences of COVID-19, including hospitalization and death”, with neither the FDA nor the companies providing clinical evidence.