Overview of U.S. COVID-19 vaccine safety surveillance systems

• Published in: Vaccine 2024-09, Vol.42, p.125748, Article 125748
• Main Authors: Gee, Julianne, Shimabukuro, Tom T., Su, John R., Shay, David, Ryan, Margaret, Basavaraju, Sridhar V., Broder, Karen R., Clark, Matthew, Buddy Creech, C., Cunningham, Francesca, Goddard, Kristin, Guy, Harrison, Edwards, Kathryn M., Forshee, Richard, Hamburger, Tanya, Hause, Anne M., Klein, Nicola P., Kracalik, Ian, Lamer, Chris, Loran, David A., McNeil, Michael M., Montgomery, Jay, Moro, Pedro, Myers, Tanya R., Olson, Christine, Oster, Matthew E., Sharma, Andrea J., Schupbach, Ryan, Weintraub, Eric, Whitehead, Brett, Anderson, Steven
• Format: Article
• Language: English
• Subjects: Adverse Drug Reaction Reporting Systems - statistics & numerical data; Adverse events; Centers for Disease Control and Prevention, U.S; Clinical trials; Collaboration; COVID-19; COVID-19 - epidemiology; COVID-19 - prevention & control; COVID-19 infection; COVID-19 vaccines; COVID-19 Vaccines - administration & dosage; COVID-19 Vaccines - adverse effects; Disease control; Electronic health records; Emergency communications systems; Emergency use authorization (EUA); Federal agencies; Federal government; Food and Drug Administration; Guillain-Barre syndrome; Health services; Heart diseases; Humans; Immunization; Immunization Programs; infrastructure; International organizations; Manufacturers; Manufacturing; Monitoring; Monitoring systems; Morbidity; mortality; mRNA; Myocarditis; Pandemics; Post-authorization safety monitoring; Product Surveillance, Postmarketing; Public health; Reporting requirements; Safety; SARS-CoV-2 - immunology; Surveillance; Surveillance systems; Telemedicine; United States; United States Food and Drug Administration; vaccination; Vaccination - adverse effects; Vaccine safety; Vaccine safety surveillance; Vaccines
• ISSN: 0264-410X; 1873-2518; 1873-2518
• DOI: 10.1016/j.vaccine.2024.02.065

The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government’s COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program.