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Review
. 2021 Jun 23;39(28):3666-3677.
doi: 10.1016/j.vaccine.2021.05.016. Epub 2021 May 14.

U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines

Diane Gubernot  1 , Amelia Jazwa  2 , Manette Niu  3 , Jane Baumblatt  4 , Julianne Gee  5 , Pedro Moro  6 , Jonathan Duffy  7 , Theresa Harrington  8 , Michael M McNeil  9 , Karen Broder  10 , John Su  11 , Satoshi Kamidani  12 , Christine K Olson  13 , Lakshmi Panagiotakopoulos  14 , Tom Shimabukuro  15 , Richard Forshee  16 , Steven Anderson  17 , Sarah Bennett  18
Affiliations
Review

U.S. Population-Based background incidence rates of medical conditions for use in safety assessment of COVID-19 vaccines

Diane Gubernot et al. Vaccine. .

Abstract

The Coronavirus Disease 2019 (COVID-19) pandemic has had a devastating impact on global health, and has resulted in an unprecedented, international collaborative effort to develop vaccines to control the outbreak, protect human lives, and avoid further social and economic disruption. Mass vaccination campaigns are underway in multiple countries and are expected worldwide once more vaccine becomes available. Some early candidate vaccines use novel platforms, such as mRNA encapsulated in lipid nanoparticles, and relatively new platforms, such as replication-deficient viral vectors. While these new vaccine platforms hold promise, limited safety data in humans are available. Serious health outcomes linked to vaccinations are rare, and some outcomes may occur incidentally in the vaccinated population. Knowledge of background incidence rates of these medical conditions is a critical component of vaccine safety monitoring to aid in the assessment of adverse events temporally associated with vaccination and to put these events into context with what would be expected due to chance alone. A list of 22 potential adverse events of special interest (AESI), including neurologic, autoimmune, and cardiovascular disorders, was compiled by subject matter experts at the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. The most recently available U.S. background rates for these medical conditions, overall and by age, sex, and race/ethnicity (when available), were sourced from reported statistics (data published by medical panels/ associations or federal government reports), and literature reviews in PubMed. This review provides estimates of background incidence rates for medical conditions that may be monitored or studied as AESI during safety surveillance and research for COVID-19 vaccines and other new vaccines.

Keywords: Adverse events; Background rates; COVID-19; Incidence rates; Surveillance; Vaccine safety.

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Conflict of interest statement

Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

References

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