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Since the first case of COVID-19 was identified in the USA in January, 2020, over 46 million people in the country have tested positive for SARS-CoV-2 infection. Several COVID-19 vaccines have received emergency use authorisations from the US Food and Drug Administration, with the Pfizer-BioNTech vaccine receiving full approval on Aug 23, 2021. When paired with masking, physical distancing, and ventilation, COVID-19 vaccines are the best intervention to sustainably control the pandemic. However, surveys have consistently found that a sizeable minority of US residents do not plan to get a COVID-19 vaccine. The most severe consequence of an inadequate uptake of COVID-19 vaccines has been sustained community transmission (including of the delta [B.1.617.2] variant, a surge of which began in July, 2021). Exacerbating the direct impact of the virus, a low uptake of COVID-19 vaccines will prolong the social and economic repercussions of the pandemic on families and communities, especially low-income and minority ethnic groups, into 2022, or even longer. The scale and challenges of the COVID-19 vaccination campaign are unprecedented. Therefore, through a series of recommendations, we present a coordinated, evidence-based education, communication, and behavioural intervention strategy that is likely to improve the success of COVID-19 vaccine programmes across the USA., Competing Interests: Declaration of interests The Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA is co-hosted by the Yale Institute for Global Health (New Haven, CT) and the Baylor College of Medicine (Houston, TX). PJH is a developer of a COVID-19 vaccine construct that was licensed by the Baylor College of Medicine to Biological E, a commercial vaccine manufacturer, for scale-up, production, testing, and licensing. NTB reports personal fees from WHO, Centers for Disease Control and Prevention, and Merck, outside the submitted work. RMC reports research grant funding from the Novo Nordisk Foundation outside the submitted work. RL reports grants from Pfizer, GlaxoSmithKline, Sanofi Pasteur, and Merck; and personal fees from Biotechnology Innovation Organization, outside the submitted work. YAM is a member of a Data Safety Monitoring Board for Pfizer and a site principal investigator for a Pfizer vaccine trial unrelated to the submitted work. MMM reports personal fees from law firms representing retail pharmacies and generic drug companies that have sued other drug companies for anti-trust law violations, outside the submitted work. DJO reports grants from the US National Institutes of Health outside the submitted work. DRR reports that herself, her spouse, and her children own stocks in GlaxoSmithKline, a vaccine manufacturer. DRR also reports serving in an unpaid volunteer capacity on Moderna's ethics allocation committee. DAS reports grants from Merck and personal fees from Pfizer, outside the submitted work. All other authors declare no competing interests., (Copyright © 2021 Elsevier Ltd. All rights reserved.)