Walgreens receives BARDA Project NextGen award to conduct novel COVID-19 decentralized clinical study
Walgreens has received a project award valued up to $25 million through the Rapid Response Partnership Vehicle to conduct a Phase IV observational clinical study focused on assessing Correlates of Protection, known as responses to a vaccine that predict how well a vaccinated person will be protected from future infections, using COVID-19 vaccine data.
The RRPV is a consortium funded by the Biomedical Advanced Research and Development Authority, part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services. This partnership underscores a shared commitment to advancing public health through innovative research and leveraging Walgreens’ extensive community pharmacies to increase access and representation in clinical trials, Walgreens said.
As a leading community pharmacy and front door to the U.S. healthcare system, Walgreens played a pivotal role in the distribution of COVID-19 vaccines and testing throughout the pandemic. Walgreens has administered over 90 million COVID-19 vaccinations to date, showcasing its capacity to handle large-scale health initiatives. Building on this experience, through this collaboration, the BARDA-funded study will utilize select Walgreens community pharmacies as clinical trial sites to assess the effectiveness of FDA-authorized COVID-19 vaccines. This initiative aims to enhance access to clinical research across diverse patient populations, particularly in communities historically underrepresented in clinical trials.
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“We are honored to be selected by BARDA and its RRPV for this important study as this is a step forward to utilize public and private partnerships to bring clinical trials into more communities across the country,” said Ramita Tandon, chief clinical trials officer at Walgreens. “With our experience in immunizations and trusted relationship with millions of patients and customers, Walgreens is uniquely positioned to support this critical research. As the only retail pharmacy with a national decentralized clinical trial infrastructure and dedicated clinical research staff, we are committed to helping enhance public health preparedness.”
Walgreens will employ a comprehensive approach to participant recruitment, which will leverage its physical footprint in addition to its compliant and secure decentralized clinical trial platform to reach patients where it’s most convenient for them. The study will enroll up to 4,000 participants across 20 retail pharmacy locations nationwide, ensuring a diverse and representative study population.
Funding for this award was received under Project NextGen, which is a $5 billion initiative by HHS to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19 than the first-generation COVID vaccines and medicines. BARDA is supporting the development of new vaccines, therapeutics and enabling technologies to better address the waning immunity and resistance to current and future SARS-CoV2 viral strains.
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This project is being funded with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Other Transaction number: 75A50123D00005.