The Administration for Strategic Preparedness and Response (ASPR), part of the US Department of Health and Human Services (HHS), today announced $25 million in funding to Walgreen's through the Biomedical Advanced Research and Development Authority (BARDA) Project NextGen to support a COVID vaccine clinical trial featuring a decentralized approach to diversify the pool of study participants.
In a news release, Dawn O'Connell, JD, assistant secretary for preparedness and response at HHS, said, "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 agreement with Walgreens, the first of its kind, will cover a vaccine correlate of protection study using licensed or authorized COVID vaccines. Correlates of protection are measurable immunity markers that correlate with protection against disease. ASPR said identifying correlates helps scientists assess immunity duration and would play a key role in vaccine development, potentially shaving time and cost off future clinical trials.
Study sites include about 20 Walgreens pharmacies
ASPR said throughout the pandemic, pharmacies and retail clinics were hubs for vaccines, treatments, and testing. It added that conducting clinical trials in decentralized locations closer to where participants live would enable scientists to collect data that reflects real-world use and harder-to-reach populations.
The clinical trial sites will include about 20 Walgreens pharmacies in urban, suburban, and rural communities.
Project NextGen is a $5 billion program led by BARDA and the National Institute of Allergy and Infectious Diseases that is geared toward streamlining the development of innovative COVID vaccines and treatments.