Walgreens Wins BARDA Project NextGen Award for New Decentralized COVID-19 Study

Walgreens, based in DEERFIELD, Ill., has been awarded a project valued up to $25 million through the Rapid Response Partnership Vehicle (RRPV) to conduct a Phase IV observational clinical study. This study focuses on assessing Correlates of Protection (CoP), which are responses to a vaccine that predict the level of protection a vaccinated individual will have against future infections, using data from COVID-19 vaccinations. The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services' (HHS) Administration for Strategic Preparedness and Response (ASPR). The partnership aims to advance public health via innovative research, leveraging Walgreens' extensive network of community pharmacies to expand access and representation in clinical trials.

Walgreens has played an essential role in the U.S. healthcare system, particularly evident in its distribution of COVID-19 vaccines and testing during the pandemic. To date, Walgreens has administered over 90 million COVID-19 vaccinations, demonstrating its ability to manage large-scale health initiatives. This collaboration with BARDA seeks to build on that experience by using select Walgreens community pharmacies as clinical trial sites to evaluate the efficacy of FDA-authorized COVID-19 vaccines. The initiative aims to make clinical research more accessible to diverse patient populations, especially communities that have been historically underrepresented in clinical trials.

Ramita Tandon, the chief clinical trials officer at Walgreens, expressed honor at being chosen by BARDA and its RRPV for this significant study. Tandon emphasized that the partnership is a critical step in utilizing public and private collaborations to bring clinical trials to more communities across the nation. Walgreens' extensive experience in immunizations and its trusted relationships with millions of customers position the company uniquely to support this vital research. Walgreens is distinguished as the only retail pharmacy with a national decentralized clinical trial infrastructure and a dedicated clinical research team. The company is committed to enhancing public health preparedness through this study.

The project intends to utilize Walgreens' wide physical presence and its secure decentralized clinical trial platform to recruit participants conveniently. Up to 4,000 participants will be enrolled across 20 retail pharmacy locations nationwide, ensuring a diverse and representative study population. This comprehensive recruitment strategy is designed to reach patients conveniently and enhance their participation in clinical research.

Funding for this initiative comes under Project NextGen, a $5 billion effort by HHS to develop new and innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19 compared to the first-generation COVID vaccines and treatments. BARDA supports the development of new vaccines, therapeutics, and enabling technologies to better tackle waning immunity and resistance to current and future SARS-CoV2 viral strains. The project is funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA).

Walgreens operates nearly 9,000 retail locations across the U.S. and Puerto Rico, serving nearly 9 million customers and patients daily. As a leading healthcare provider, Walgreens offers a wide range of pharmacy and healthcare services, aiming to improve care, lower costs, and assist patients. The company prides itself on providing equitable access to care, especially for underserved populations, and offers an omnichannel experience through its integrated physical and digital platforms.