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

• Authors: Diane Gubernot, U.S. Food and Drug Administration; Amelia Jazwa, Centers for Disease Control and Prevention, Atlanta; Manette Niu, U.S. Food and Drug Administration; Jane Baumblatt, U.S. Food and Drug Administration; Julianne Gee, Centers for Disease Control and Prevention, Atlanta; Pedro Moro, Centers for Disease Control and Prevention; Jonathan Duffy, Centers for Disease Control and Prevention, Atlanta; Theresa Harrington, Centers for Disease Control and Prevention, Atlanta; MM McNeil, Centers for Disease Control and Prevention, Atlanta; Karen Broder, Centers for Disease Control and Prevention, Atlanta; John Su, Centers for Disease Control and Prevention, Atlanta; Satoshi Kamidani, Emory University; Christine K Olson, Centers for Disease Control and Prevention, Atlanta; Lakshmi Panagiotakopoulos, Centers for Disease Control and Prevention, Atlanta; Tom Shimabukuro, Centers for Disease Control and Prevention, Atlanta; Richard Forshee, U.S. Food and Drug Administration; Steven Anderson, U.S. Food and Drug Administration; Sarah Bennett, Centers for Disease Control and Prevention, Atlanta
• Journal Title: VACCINE
• Volume: Volume 39, Number 28
• Publisher: ELSEVIER SCI LTD | 2021-06-11, Pages 3666-3677
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1016/j.vaccine.2021.05.016
• Subjects: Health Sciences, Medicine and Surgery
• Keywords: Science & Technology; Life Sciences & Biomedicine; Immunology; Medicine, Research & Experimental; Research & Experimental Medicine; Background rates; Incidence rates; Vaccine safety; Adverse events; COVID-19; Surveillance; GUILLAIN-BARRE-SYNDROME; ACUTE DISSEMINATED ENCEPHALOMYELITIS; IDIOPATHIC THROMBOCYTOPENIC PURPURA; H1N1 INFLUENZA VACCINATION; UNITED-STATES; OLMSTED COUNTY; MULTIPLE-SCLEROSIS; SMALLPOX VACCINATION; UNPROVOKED SEIZURES; KAWASAKI-DISEASE

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.