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Emergency Use Authorization of Covid Vaccines — Safety and Efficacy Follow-up Considerations
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Use of an investigational vaccine under an EUA would not be subject to the usual informed consent requirements for clinical investigations; nevertheless, vaccine recipients will be provided a fact sheet that describes the investigational nature of the product, the known and potential benefits and risks, available alternatives, and the option to refuse vaccination.
https://www.nejm.org/doi/full/10.1056/NEJMp2031373
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When the world wearies and society ceases to satisfy, there is always the garden - Minnie Aumônier