Walgreens has received $25 million in grant funding to conduct a decentralized clinical trial assessing how well a person vaccinated against COVID-19 is protected from future infections.
The award funding comes from a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), embedded in the U.S. Department of Health and Human Services. The partnership is BARDA’s first with a major retail pharmacy. Walgreens will conduct a phase IV observational clinical study, using COVID vaccine data, to assess 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 initiative’s goal is to increase access to clinical trials. Currently, participants in a vaccine clinical trial often travel to hospitals, universities or other central locations that are far from their homes. Taking a decentralized approach through a geographically diverse retailer like Walgreens can help reach patients where they are and enable the collection of real-world data, the organizations said. The partners also hope that learning what aspects of decentralized clinical trials work for vaccine correlates of protection studies can help drive future studies at scale.
“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,” HHS’ Assistant Secretary for Preparedness and Response Dawn O’Connell said in a press release. “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.”
Walgreens was a major player in the distribution of COVID vaccines and testing, administering 90 million vaccinations to date. Building on this, the BARDA-funded study will use select Walgreens community pharmacies as clinical trial sites. The effort aims to enhance access to clinical research across diverse patient populations, particularly in historically underrepresented communities.
“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,” Ramita Tandon, chief clinical trials officer at Walgreens, said in a press release. “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.”
Establishing correlates of immunity helps scientists understand more about how the protective immunity of vaccines lasts over time, which can inform public health guidelines. These metrics also help scientists evaluate vaccines and figure out how to improve them.
Walgreens plans to leverage its footprint and its decentralized clinical trial platform to recruit participants. The study will enroll up to 4,000 people across 20 retail pharmacy locations across the country.
The retail pharmacy giant continues to build out its clinical trials business as it looks to diversify its business beyond just pharmacy. Walgreens launched its clinical trials unit back in June 2022 as the company's healthcare ambitions continue to grow. The company has signed more than 35 clinical trial contracts with drugmakers including Freenome and Prothena.
The company signed a deal with Boehringer Ingelheim in May to use its community pharmacies as clinical trial sites for people living with obesity, overweight and type 2 diabetes.
Funding for the latest award came from Project NextGen, a $5 billion initiative led by BARDA and the National Institute of Allergy and Infectious Diseases. The initiative aims to advance new vaccines, therapeutics and enabling technologies to address COVID-19. To date, BARDA has provided $2.6 billion in Project NextGen funds to industry partners. BARDA also has a new program, dubbed D-COHRe, that aims to scale up the capacity for decentralized clinical trials in preparation for future pandemics.