Preliminary guidance on safety data collection for COVID-19 vaccine safety

This deliverable provides guidance on the collection of safety data for COVID-19 vaccine candidates. This includes a brief discussion of the types of safety data to collect in trials, a sample memory aid template for collection of solicited local and systemic reactions with guidance re: data analysis and presentation, a literature search on enhanced disease and a report of the consensus conference on enhanced disease following immunization.

See Below document to download SO2-D2.4_Preliminary guidance on safety data collection for COVID-19 vaccine safety_V1.0

 

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