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V-safe active surveillance for COVID-19 vaccine safety. Version 3, May 20, 2021
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May 20, 2021
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Description:V-safe is an active surveillance program to monitor the safety of COVID-19 vaccines during the period when the vaccines are authorized for use under Food and Drug Administration (FDA) Emergency Use Authorization (EUA) and possibly early after vaccine licensure. V-safe is a new smartphone-based system that uses text messaging to initiate web-based survey monitoring in the form of periodic health check-ins to assess for potential adverse events following vaccination CDC will use the follow-up capability of the existing Vaccine Adverse Event Reporting System (VAERS) call center to conduct active telephone follow-up on recipients reporting a significant, medically attended health impacts during v-safe health check-ins. The purpose of v-safe surveillance is to rapidly characterize the safety profile of COVID-19 vaccines when given outside a clinical trial setting and to detect and evaluate clinically important adverse events and safety issues that might impact policy or regulatory decisions.
V-safe-Protocol-508.pdf
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Pages in Document:55 numbered pages
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