Research Centers of America (“RCA”), a CenExel Center of Excellence, joined nearly 100 other clinical research facilities across the United States to test the safety and efficacy of Moderna’s mRNA-1273 vaccine against COVID-19. The published results in The New England Journal of Medicine showcased that the trial enrolled 30,420 volunteers and found an overall vaccine efficacy rate of 94.1%. Although moderate, short-lived reactogenicity occurred more often in the mRNA-1273 group, these reactions are typical for vaccinations. Severe adverse events were rare and occurred roughly as often between both the placebo and mRNA-1273 groups.
Dr. Howard Schwartz, Chief Medical Officer and Principal Investigator at RCA and a widely-published author, contributed the Center’s findings to the study as part of his authoring partnership for the article. “The data demonstrated strong safety and efficacy results from a novel mRNA COVID-19 vaccine,” he said. “These welcome and extremely positive indications are a breath of fresh air after a turbulent year.”
RCA and the entire 5-site CenExel network were uniquely positioned to move this study forward by relying on their profound experience in vaccine research and on-site labs for working with peripheral blood mononuclear cells (PBMC). Professional, full-time staff at these clinical trial facilities have conducted extensive research on vaccines for many viruses already, including seasonal and pandemic influenza, Ebola, smallpox, West Nile Virus, and Zika. The PBMC labs allow for the isolation, cryopreservation, and shipping of PBMC, which is essential for accurate results in a vaccine trial.
“Our whole site network has been able to participate in key studies in Operation Warp Speed,” said Tom Wardle, CenExel CEO. “In the past several years, our Centers have supported over 100 vaccine trials and surpassed recruitment goals by 110%. We have enrolled over 5,000 patients in six of the seven Operation Warp Speed studies, with 40% of the patients representing diverse minority groups. Throughout these efforts, we maintained the strictest safety measures and the highest quality of work.”
The mRNA-1273 vaccine was developed by Moderna and the Vaccine Research Center at the National Institute of Allergy and Infectious Diseases (NIAID), within the National Institutes of Health (NIH). The study was conducted between late July and October, 2020, with adjustments to the site selection and enrollment processes to maximize racial and ethnic minority representation among volunteers.
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About Research Centers of America
RCA (www.RCATrials.com) is a privately-owned, multi-specialty research site that conducts Phase I – IV clinical trials. RCA inpatient and outpatient studies are made up of healthy and special populations ranging from pediatric to geriatric age groups. Our mission is to be the best-in-class clinical research site contributing to the development of new medications by conducting trials at the highest ethical standards. We are a CenExel Center of Excellence, assuring unparalleled patient engagement, staff expertise, and valuable results.
About CenExel Clinical Research
CenExel Clinical Research (www.CenexelResearch.com) provides unparalleled medical and scientific support in the design and execution of clinical trials. The attention to detail assures quality, reliable results and has helped CenExel to consistently achieve and exceed patient recruitment goals. CenExel Centers of Excellence have conducted thousands of studies, the variety and complexity of which have resulted in a vast depth of experience and insight for the principal investigators and research staff in each facility. The CenExel Centers of Excellence deliver the engagement, expertise, and results to ensure that their clients achieve their clinical research goals.