Vaccine Risk Monitoring and Evaluation at the Centers for Disease Control and Prevention

Vaccines have been recognized as one of the most significant public health achievements of the 20th century. However, despite rigorous scientific scrutiny, COVID vaccines became suspect to some due to confusion, concern, and mistrust about recommended public health measures employed during the nationwide COVID pandemic public health emergency. The Centers for Disease Control and Prevention's (CDC) Immunization Safety Office (ISO) is responsible for studying vaccine risks once vaccines are administered to the public and was a federal focal point for vaccine risk evaluation prior to and throughout the COVID pandemic.

The CDC requested that the National Academies convene an expert committee to assess ISO's statistical and epidemiological methods in vaccine risk monitoring and evaluation, including processes designed to detect, evaluate, and report potential problems associated with COVID vaccines. The committee was also charged with evaluating CDC's external communication strategies and providing recommendations to sustain and enhance ISO's vaccine risk monitoring and communication systems. The resulting report presents the committee's conclusions and recommendations.

Table of Contents

Front Matter Summary 1 Introduction 2 Data Monitoring and Evaluation 3 Communications 4 Conclusions and Recommendations Appendix A: Committee Member and Staff Biographies Appendix B: Public Meeting Agendas for the Committee to Review the Center for Disease Control and Prevention's COVID-19 Vaccine Safety Research and Communications Appendix C: Westat Key Informant Interviews Findings Report Appendix D: Case Studies Appendix E: Catalog of Data-Driven Literature from CDC Vaccine Safety Monitoring