BARDA Awards $25 Million to Walgreens for Decentralized Clinical Trial

According to a July 23 press release, the Administration for Strategic Preparedness and Response’s Biomedical Advanced Research and Development Authority (BARDA) will provide $25 million in Project NextGen funding to Walgreens to conduct a decentralized clinical trial.

The effort aims to increase access to clinical trials, enabling more people of diverse backgrounds to participate.

“Today’s announcement is the latest demonstration of our commitment to ensuring that health equity is built into all of our preparedness, response and recovery activities,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “Americans are diverse. Clinical trials should be, too. We want to make clinical trials easy to access so that more people who want to participate can do so.”

The press release adds, “The award was made through BARDA’s Rapid Response Partnership Vehicle, managed by Advanced Technologies International. Under the agreement, Walgreens will conduct a Phase IV vaccine correlate of protection clinical study using an FDA-authorized or licensed COVID-19 vaccine.”

Further, “Correlates of protection, also known as correlates of immunity, are measurable markers of immunity that correlate with protection against disease. Establishing correlates helps scientists and others understand more about how the protective immunity of vaccines lasts over time, which in turn informs public health guidelines. Correlates of protection also help scientists evaluate vaccines, providing information on how to improve vaccines, and potentially saving time and reducing the cost of clinical trials for development of future vaccines.”

At present, volunteers often travel far from their homes to central locations that are established as clinical trial sites. For the study, approximately 20 Walgreens pharmacy stores will serve as clinical trial sites in urban, suburban, and rural communities across the United States. Walgreens plans on providing information on how/where to participate, to recruit study volunteers.