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 Draft CISA Project clinical consult work plan document for vaccine safety planning

December 5, 2020

Prepared by the CISA Project Team, Immunization Safety Office (ISO), Centers for Disease Control and Prevention (CDC), with input from CISA sites

This is a draft technical document to guide CDC's Clinical Immunization Safety Assessment (CISA) Project emergency response preparations for the COVID-19 response. This document may be updated in the future.

CDC's Immunization Safety Office (ISO) is expanding the role of the Clinical Immunization Safety Assessment (CISA) Project to implement the COVID-19 On-Call Clinical Consultation Service for Vaccine Safety. This effort is a collaboration between CDC and partners in the CISA Project medical research centers. This document describes the organization, activities, and key roles for this service. aims to provide a secondary level of support for complex clinical vaccine safety inquiries from U.S. healthcare providers and health department staff that are not readily addressed by CDC or Advisory Committee on Immunization Practices (ACIP) guidelines. The key activities include: providing expert consultation for approximately 10 complex COVID-19 vaccine safety case reviews or clinical inquiries per week from healthcare providers and health departments in the United States; providing CDC staff with ready access to medical experts in infectious diseases and other medical disciplines for adult and pediatric medicine; maintaining a 24/7 on-call service to address emergency clinical inquiries about COVID-19 vaccine safety; and, assisting CDC and partners in assessing emerging COVID-19 vaccine safety issues. In addition, staff will operate secure tracking databases for COVID-19 vaccine safety clinical consults conducted through the service.

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