Retail pharmacy Walgreens to study effectiveness of COVID-19 vaccines in decentralized clinical study

The HHS has granted Walgreens $25 million to conduct a decentralized COVID-19 vaccine trial, enhancing participation and gathering real-world data from diverse communities.

The US Department of Health and Human Services (HHS) has granted Walgreens $25 million to conduct a decentralized clinical trial evaluating licensed COVID-19 vaccine effectiveness. The phase IV observational study is funded through the Rapid Response Partnership Vehicle (RRPV), a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA). BARDA is part of the Administration for Strategic Preparedness and Response (ASPR) within HHS. The study aims to gather real-world data while increasing participation across diverse age groups and ethnicities.

The study will focus on assessing correlates of protection (CoP) – vaccine responses that predict future infection protection. Walgreens will utilize select community pharmacies as clinical trial sites, enrolling up to 4000 participants across 20 locations nationwide.

Ramita Tandon, Chief Clinical Trials Officer at Walgreens, stated,

“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. With our experience in immunizations and trusted relationship with millions of patients and customers, Walgreens is uniquely positioned to support this critical research.”

This initiative builds on Walgreens’ significant role in COVID-19 vaccine distribution, having administered over 90 million vaccinations to date. The decentralized approach aims to enhance access to clinical research, particularly in communities historically underrepresented in such trials.

Dawn O’Connell, Assistant Secretary for Preparedness and Response, emphasized,

“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. 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 project is part of HHS’s US$5 billion Project NextGen initiative, which aims to advance innovative vaccines and therapeutics for broader and more durable COVID-19 protection. Led by BARDA and the National Institute of Allergy and Infectious Diseases (NIAID), this effort focuses on developing next-generation COVID-19 countermeasures and addressing waning immunity and viral strain resistance.

BARDA Director Gary Disbrow, PhD, commented,

“At BARDA, we are committed to advancing clinical trial capabilities that remove barriers to participation and improve accessibility. Enabling diverse representation and data in clinical trials will help us to develop products that reflect the people and communities that need them most.”

This project is BARDA’s first pharmacy-based decentralized clinical trial, aiming to expand clinical research into more communities across the US. By utilizing Walgreens’ extensive network and secure clinical trial platform, the study intends to provide convenient access for participants and ensure a diverse and representative study population.