Research Centers of America in southeastern Florida has announced that the independent research site is now conducting COVID-19 vaccine trials, implemented under Operation Warp Speed (OWS), which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by January 2021.
OWS is a partnership that includes the Department of Health and Human Services, the Centers for Disease Control and Prevention (CDC), the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority, and the Department of Defense (DoD).
Research Centers of America said the site is currently recruiting volunteers to participate in clinical trials, working with the federal government and major pharmaceutical companies, which developed a vaccine to potentially prevent COVID-19.
In a July 27 press release Moderna said the first trial is expected to enroll approximately 30,000 participants in the United States. RCA will recruit between 300 to 500 participants for Moderna’s trial alone.
“The randomized, placebo-controlled trial is expected to include approximately 30,000 participants in the United States,” Moderna said in a July 27 statement. “The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2 regardless of symptomology. SARS-CoV-2 is the virus that causes COVID-19.”
To ensure the ongoing safety of participants in the trial, data will be reviewed by an independent Data and Safety Monitoring Board organized by the NIH’s National Institute of Allergy and Infectious Diseases, or NIAID, which is conducting research on SARS CoV-2 and the disease COVID-19 throughout the study.
RCA specializes in conducting Phase I-IV vaccines and trials for pharmaceutical and biotech companies. RCA team members have executed over 1000 research studies across multiple therapeutic areas.
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