BARDA Teams Up with ICON for Advancing COVID-19 Vaccine Clinical Trial

Thursday, September 14, 2023

ICON plc, a globally recognized healthcare intelligence and clinical research organization listed on NASDAQ under the ticker symbol ICLR, has made a noteworthy announcement about its collaboration with the U.S. Biomedical Advanced Research and Development Authority (BARDA). BARDA is an integral part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services. Their joint venture aims to conduct a pivotal clinical trial to assess the effectiveness of the next-generation COVID-19 vaccine candidates.

The decision to explore next-generation COVID-19 vaccines is rooted in their potential to enhance protection against current and future virus variants, prolong the duration of immunity, and provide more robust defenses against illness and transmission compared to existing vaccine technologies. ICON's Government & Public Health Solutions team is tasked with overseeing the execution of a Phase 2b clinical trial, specifically designed to evaluate the relative efficacy of a next-generation COVID-19 vaccine in preventing symptomatic, PCR-confirmed SARS-CoV-2 infection when compared to currently approved or authorized COVID-19 vaccines.

This ambitious clinical trial is set to enroll 10,000 subjects over a period of six months. Notably, BARDA will play a crucial role in selecting the specific vaccine candidate for investigation. This decision will expedite the commencement of the Phase 2b clinical trial and ensure a robust and meaningful comparison with existing vaccines.

ICON brings to the table extensive experience in vaccine clinical development, with active participation in over 184 vaccine studies in the past five years. This wealth of experience has already positioned ICON as a significant contributor to the global efforts to combat COVID-19. The company has been actively involved in the development of several approved vaccines and is currently engaged in or has completed over 86 COVID-19-related trials.

Edward Wright, President of ICON Government & Public Health Solutions, expressed satisfaction with the partnership with BARDA. He underscored the critical role of timely clinical research, particularly in the context of emerging virus variants. ICON's proven expertise in conducting efficient and comprehensive COVID-19 trials positions the company to provide crucial support to scientific leaders in this critical area.

In addition to its Government & Public Health Solutions division, ICON leverages the expertise of its biotech division, which comprises more than 8,000 dedicated professionals serving biotech customers. As the world's largest dedicated biotech division, this team collaborates with over 500 biotech sponsors annually.

Chris Smyth, President of ICON Biotech Solutions, emphasized ICON's deep understanding of the pivotal role played by biotech firms in innovative drug development. He highlighted their unique requirements for portfolio expansion and expressed eagerness for the opportunity to contribute to this significant clinical trial.

This collaboration is an integral part of Project NextGen, a collaborative initiative spanning the U.S. Government and the private sector. It aims to advance innovative vaccines and therapeutics through clinical trials, regulatory scrutiny, and potential commercialization.
BARDA's mission encompasses the development of medical countermeasures to safeguard the U.S. against various threats, including chemical, biological, radiological, nuclear incidents, pandemic influenza, and emerging infectious diseases.

Since 2014, ICON has played a vital role as a member of BARDA's Medical Countermeasures Clinical Studies Network (CSN). ICON actively supports the planning and implementation of clinical studies for medical countermeasure development. Their involvement in numerous clinical trials within this network includes their recent execution of an anthrax vaccine clinical trial.

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