Walgreens secures $25M BARDA grant for COVID-19 vaccine trial

Walgreens has secured $25 million in grant funding to carry out a decentralized clinical trial investigating the efficacy of COVID-19 vaccinations in preventing future infections. This funding comes from a consortium supported by the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services (HHS). Notably, this marks BARDA's inaugural collaboration with a major retail pharmacy for such an initiative.

The trial will be a phase IV observational study, utilizing existing COVID-19 vaccination data to identify correlates of protection. These correlates are responses to a vaccine that indicate how effectively a vaccinated individual is shielded from subsequent infections. The primary aim is to enhance access to clinical trials, as current vaccine trial participants often have to travel considerable distances to central locations like hospitals and universities. By leveraging a decentralized approach through Walgreens' extensive geographic reach, the organizations hope to make participation easier and gather real-world data more effectively.

This initiative is seen as a step toward ensuring health equity, according to Dawn O'Connell, HHS’ Assistant Secretary for Preparedness and Response. "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," O'Connell stressed.

Walgreens has been a significant player in the distribution of COVID-19 vaccines, having administered 90 million vaccinations to date. The BARDA-funded study will use selected Walgreens community pharmacies as clinical trial sites to improve access to clinical research, especially in historically underrepresented communities.

Ramita Tandon, Walgreens' Chief Clinical Trials Officer, expressed pride in being chosen for this important study. "With our experience in immunizations and trusted relationship with millions of patients and customers, Walgreens is uniquely positioned to support this critical research," Tandon said. As the only retail pharmacy with a national decentralized clinical trial infrastructure and dedicated clinical research staff, Walgreens is committed to enhancing public health preparedness through this effort.

Establishing correlates of immunity is crucial for scientists to understand the duration of vaccine-induced protective immunity, which can guide public health policies. These metrics also aid in evaluating and improving vaccines.

Walgreens plans to recruit up to 4,000 participants for the study, which will be conducted across 20 retail pharmacy locations nationwide. This trial is part of Walgreens' broader strategy to expand its clinical trials business beyond traditional pharmacy services. The company launched its clinical trials unit in June 2022 and has since signed over 35 clinical trial contracts with pharmaceutical companies, including Freenome and Prothena.

In addition to this study, Walgreens signed an agreement with Boehringer Ingelheim in May to use its community pharmacies as clinical trial sites for individuals dealing with obesity, overweight, and type 2 diabetes.

The funding for this latest award came from Project NextGen, a $5 billion initiative spearheaded by BARDA and the National Institute of Allergy and Infectious Diseases. The project aims to advance new vaccines, therapeutics, and enabling technologies to combat COVID-19. To date, BARDA has allocated $2.6 billion in Project NextGen funds to various industry partners. Moreover, BARDA has launched a new program called D-COHRe, designed to scale up decentralized clinical trials in anticipation of future pandemics.