Cassandra Ventrone, research technician in UVM's Vaccine Testing Center, processes materials for the AstraZeneca COVID-19 vaccine trial. (Photo: Ryan Mercer, UVM Medical Center)
The University of Vermont Medical Center and the Vaccine Testing Center at the University of Vermont's Larner College of Medicine have successfully reached and surpassed the targeted number of enrollees for an ongoing Phase 3 clinical trial of the AstraZeneca COVID-19 vaccine.
The goal of 250 enrolled and dosed volunteers was met in just four weeks – with more than 3,100 people registering to take part. The local vaccine trial was able to enroll nearly 65 percent of volunteers who are over the age of 65 – a critically important demographic for testing efficacy and safety and a unique, local contribution to the nationwide study. Additionally, more than 12 percent of participants identify as black, indigenous or persons of color.
Enrollment in the study was completed just before the end of the year on December 22. The UVM Medical Center site dosed 284 individuals with vaccine or placebo, evenly split between men and women.
“We owe a large debt of gratitude to our community volunteers who participated in this important final stage of evaluation of this COVID vaccine with our research team at UVM Medical Center,” said Beth Kirkpatrick, M.D., co-director of the Vaccine Testing Center, chair of microbiology and molecular genetics, and an infectious disease expert at UVM Medical Center. "No COVID vaccine reaches final FDA approval without the incredible dedication and willingness of these many volunteers. We have enjoyed meeting some of the amazing people of Vermont and the region over the past several weeks and we are grateful and very proud of them."
"We would also like to thank the tremendous efforts of the whole research team, all of the many individuals that help us set up the nuts and bolts of this research site, as well as the support of the leadership of UVM Medical Center and the Larner College of Medicine,” said Kristen Pierce, M.D., co-director of the Vaccine Testing Center, professor of medicine, and an infectious disease expert at UVM Medical Center.
Participants in the study will continue to be monitored for about two years. The AstraZeneca vaccine has not yet been approved for use in the United States. It was recently approved for use in the United Kingdom by the U.K. regulatory authorities, based on other, smaller studies performed in the U.K. and Brazil. The U.S.-based trial will be the largest and most uniformly-designed trial of the AstraZeneca COVID-19 vaccine. Data from this trial is hoped to be ready for FDA review in the coming weeks or months. AstraZeneca is thought to have the largest manufacturing capacity for a COVID-19 vaccine, and has created a vaccine that is less expensive and easier to store than other COVID-19 vaccines. The company plans to make 3 billion doses in 2021 for distribution globally.