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The guidance provides recommendations for data and information needed to support an EUA for COVID-19 vaccines.
FDA published guidance on Oct. 6, 2020 for developers requesting Emergency Use Authorization (EUA) for COVID-19 vaccines. The guidance provides recommendations for the data and information that will be needed to support an EUA.
The guidance states that an EUA may be issued if, “Based on the totality of scientific evidence available, including data from adequate and well-controlled trials, if available, it is reasonable to believe that the product may be effective to prevent, diagnose, or treat such serious or life-threatening disease or condition that can be caused by SARS-CoV-2.” In addition, the benefits of the product should outweigh any “known or potential risks of the product,” and there should be no other “adequate, approved, and available alternative to the product for diagnosing, preventing, or treating the disease or condition.”
The document discusses regulatory information that must be submitted with the EUA; chemistry, manufacturing, and controls information; and safety and effectiveness information. FDA also provides key logistic recommendations and considerations for continuing clinical trials after the EUA is issued.