Icon, a prominent Contract Research Organization (CRO), has been chosen by the US Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) to spearhead a critical clinical trial. This extensive study aims to evaluate the efficacy of next-generation COVID-19 vaccines, with a focus on combating future variants of the virus and extending long-term protection.
In an official press release dated September 13, Icon revealed that this groundbreaking trial will encompass a staggering 10,000 patients. The primary objective is to scrutinize the performance of these vaccine candidates against potential mutations of the virus. The enrollment process is slated to span six months, with BARDA making the crucial selection of the vaccine to be subjected to the rigorous phase 2b clinical trial.
While the financial particulars of this collaboration remain undisclosed, the venture is an integral component of Project NextGen. This initiative serves as a vital conduit, fostering collaboration between the US government and the private sector, with the overarching goal of advancing vaccines and therapeutics seamlessly through clinical trials, regulatory evaluations, and, ultimately, potential commercialization.
In a related development, the FDA recently granted approval for modified mRNA vaccines targeting COVID-19, developed by Pfizer-BioNTech and Moderna. These adapted formulations are finely tuned to address the current variants of the disease. Notably, both vaccines are approved for individuals aged 12 and above, with emergency authorization extending to patients as young as 6 months to 11 years old.
“We are pleased to be partnering with BARDA on this research at an important juncture in the fight against COVID-19. As new variants emerge, timely clinical research has a pivotal role to play in helping ensure the development of medicines is accelerating as quickly as possible in line with the virus. Our experience in executing COVID-19 trials effectively, efficiently and thoroughly means we are well placed to support those sponsors who are at the scientific forefront in this area.”
– Edward Wright, President, ICON Government & Public Health Solutions
While these developments signify significant progress in the fight against COVID-19, it’s worth noting that Novavax’s revised COVID-19 vaccine is still awaiting regulatory approval, further underlining the importance of ongoing research and clinical trials in our collective battle against the virus.
Icon’s pivotal role in conducting this expansive clinical trial reinforces the commitment of both public and private sectors to stay ahead of the virus’s mutations, ensuring the ongoing protection and well-being of the population. As the world watches these developments unfold, the collaborative efforts under Project NextGen shine as a beacon of hope in the ongoing fight against COVID-19.
“In addition to our vaccine clinical development experience, we understand the important role biotech companies have in innovative drug development, and the specific requirements they have as they look to develop their portfolios. We are pleased to have the opportunity to work with them on this trial.”
– Chris Smyth, President, ICON Biotech Solutions