Consensus Study Report

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COMMITTEE TO REVIEW THE CENTERS FOR DISEASE CONTROL AND PREVENTION’S COVID-19 VACCINE SAFETY RESEARCH AND COMMUNICATIONS

JANE E. HENNEY (Chair)

DENISE H. CHRYSLER, Network for Public Health Law

LAWRENCE DEYTON, George Washington University

FRANCISCO GARCÍA, University of Arizona

KRISHIKA A. GRAHAM, New York City Department of Health and Mental Hygiene

MARIE R. GRIFFIN, Vanderbilt University Medical Center

PERRY N. HALKITIS, Rutgers University

SONIA HERNÁNDEZ-DÍAZ, Harvard T.H. Chan School of Public Health

ALI S. KHAN, University of Nebraska Medical Center

DANIELLA MEEKER, Yale University

GLEN NOWAK, University of Georgia

OLAYINKA SHIYANBOLA, University of Michigan College of Pharmacy

LILLIE D. WILLIAMSON, University of Wisconsin–Madison

National Academy of Medicine Fellow

JENNIFER BACCI, University of Washington School of Pharmacy

Study Staff

KATHLEEN STRATTON, Study Director, Scholar

OGAN K. KUMOVA, Program Officer

DARA ANCONA, Associate Program Officer

KATIE PETERSON, Senior Program Assistant (from December 2024)

OLIVIA LOIBNER, Senior Program Assistant (until August 2024)

ROSE MARIE MARTINEZ, Senior Board Director, Board on Population Health and Public Health Practice

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Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before

its release. The review of this report was overseen by CATHERINE E. WOTECKI, Iowa State University, and PAUL A. VOLBERDING, University of California, San Francisco. They responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Acknowledgments

The Committee to Review the Centers for Disease Control and Prevention’s COVID-19 Vaccine Safety Research and Communications and the Board on Population Health and Public Health Practice staff would like to thank the many individuals who contributed to the development of this report.

The committee acknowledges the support of staff in the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine, particularly the guidance and efforts of Kathleen Stratton (study director), Ogan Kumova (program officer), and Dara Ancona (associate program officer), whose work in gathering research, organizing meetings, and shaping, editing, and fact-checking this report was invaluable. The committee also extends its appreciation to Katie Peterson for her support with meeting logistics and manuscript preparation. Rose Marie Martinez (Senior Board Director, Board on Population Health and Public Health Practice) provided essential guidance to both the committee and staff throughout the process.

The committee would also like to thank Dr. John Su, Ms. Julianne Gee, and Dr. Daniel Jernigan for their informative presentations about the committee’s charge and the current structure and role of the Immunization Safety Office and its safety monitoring systems. Additionally, the committee thanks invited speakers Dr. Reed Tuckson, Dr. Malia Jones, and Dr. Scott Razan for sharing their perspectives on the challenges and opportunities for research and communication related to vaccine safety.

Additional support for this report was provided by Misrak Dabi and Greysi Patton (Finance Business Partners), Crysti Park (Program Coordinator), Lori Brenig (Editorial Projects Coordinator), Taryn Young (Report Review Associate), Leslie Sim (Senior Report Review Officer), Marguerite Romatelli (Communications Specialist), Amber McLaughlin (Director of Communications), and Tasha Bigelow (copyeditor), all of whom offered outstanding assistance during each phase of the study.

Finally, the committee expresses its gratitude to the members of the public who shared their insights via email correspondence and public comments, and to those who participated in the key informant interviews, which informed the committee’s work and enriched the report.

Contents

ACRONYMS AND ABBREVIATIONS

SUMMARY

1 INTRODUCTION

Vaccine Safety Assessment

CDC ISO

Committee Approach to the Statement of Task

Report Structure and Terminology

References

2 DATA MONITORING AND EVALUATION

ISO Monitoring and Evaluation/Assessment Systems

Major Methodologic Strengths/Limitations of Findings/Safety Assessments from Each of the Major Systems

Timeliness and Completeness of Signals

Opportunity/Attention Costs

Additional Unpublished, Real-Time Findings/Safety Assessments

Conclusion

References

3 COMMUNICATIONS

Public Health Communications

Vaccine and Vaccination-Related Benefit–Risk Communication

Vaccine Safety Communications at the Centers for Disease Control and Prevention (CDC)

Communications During the PHE

Assessment of CDC Vaccine Risk Communications

Conclusion

References

4 CONCLUSIONS AND RECOMMENDATIONS

Conclusions

Recommendations

Public Health Emergencies

Concluding Thoughts

References

APPENDIXES

A Committee Member and Staff Biographies

B Public Meeting Agendas

C Westat Key Informant Interviews Findings Report

D Case Studies

E Catalog of Data-Driven Literature from CDC Vaccine Safety Monitoring

Boxes, Figures, and Tables

BOXES

1-1 Statement of Task

1-2 Emergency Use Authorization (EUA)

1-3 Key Functions of the Immunization Safety Office (ISO)

1-4 Salient Points from Public Comment

3-1 CDC Vaccine Safety Communication Efforts

4-1 Principles of a Robust Vaccine Risk Monitoring and Evaluation System That Merits the Nation’s Trust

FIGURES

S-1 Committee’s understanding of ISO workflow

1-1 Committee’s understanding of ISO workflow

3-1 CDC vaccine safety key audiences and communications

3-2 CDC vaccine safety communication activities timeline during the public health emergency

3-3 CDC vaccine safety communications routine clearance process vs. clearance process during the COVID public health emergency

TABLES

S-1 ISO-Affiliated COVID Vaccine Risk Monitoring Systems

1-1 Vaccine Offices in the Department of Health and Human Services

2-1 Key Strengths and Limitations of CDC COVID Vaccine Safety Surveillance Systems

2-2 Description of Non-CDC COVID Vaccine Safety Data Sources Relevant to ISO

2-3 Cross-System Summary of Major COVID Vaccine Safety Signals, Principal Findings, and Surveillance Periods

2-4 Selected COVID Vaccine-Safety Signals—Timeline from Initial VaST Review to Public Disclosure, Peer-Reviewed Evidence, and Action

3-1 Publicly Available CDC Vaccine Safety Communications

3-2 CDC COVID-19 Vaccine Safety Task Force Teams

Acronyms and Abbreviations

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