As the Food and Drug Administration (FDA) has approved adding a third COVID-19 vaccine to the rollout, a multicenter study led by Vanderbilt University Medical Center will evaluate how effective the vaccines are in preventing hospitalization from COVID-19.
In 2020, clinical trial data showed that the current SARS-CoV-2 vaccines were effective at preventing infections and severe illness from COVID-19 in the clinical trial setting.
This study will determine how well these vaccines are working in real-world settings as they are given to large populations across the country, said Wesley Self, MD, MPH, associate professor and vice chair for Research in the Department of Emergency Medicine, Vice President for Clinical Research Networks & Strategy in the Vanderbilt Institute for Clinical and Translational Research (VICTR), and the study’s principal investigator.
Hospitalized adults with COVID-19, and two control groups who do not have COVID-19, will be enrolled at 21 hospitals, nationwide, for a 10-month period. The study will be conducted by the Influenza and Other Viruses in the Acutely Ill (IVY) Network, which is a national research collaborative led by VUMC.
“By comparing vaccination rates in the patients hospitalized with COVID-19 and control groups without COVID-19, we will estimate how effective the vaccine is at preventing COVID-19-associated hospitalizations,” Self said. “We will be comparing the effectiveness of different vaccine types that are being used in the U.S. and investigating why some patients have a vaccine failure, that is, why some people become severely ill with COVID-19 despite vaccination.”
“It will be critically important to understand if certain people are not adequately responding to the vaccine or if new viral variants are evading the protection of vaccines,” he said.
Data from this study will be sent to the Centers for Disease Control and Prevention (CDC) every two weeks to help inform those creating U.S. vaccination policies.
“It is an honor to have been selected by CDC to do this important work of evaluating SARS-CoV-2 vaccine effectiveness as the vaccines roll out in the U.S. over the next year. I am incredibly proud of our team, which has been leading the IVY Network for the past two years and has taken on the challenge of conducting clinical research during the pandemic,” Self said.
Other Vanderbilt investigators include, Keipp Talbot, MD, MPH, associate professor of Medicine; Todd Rice, MD, MSc, associate professor of Medicine; Christopher Lindsell, PhD, professor of Biostatistics; Carlos Grijalva, MD, MPH, associate professor of Health Policy; Ian Jones, MD, associate professor of Emergency Medicine; Natasha Halasa, MD, MPH, associate professor of Pediatrics; Jim Chappell, MD, PhD, associate professor of Pediatrics; Bo Stubblefield, MD, instructor in Emergency Medicine; and Jon Casey, MD, MSCI, assistant professor of Medicine.
The study is funded by the CDC,.
