Adults who are interested in joining this study can visit www.coronaviruspreventionnetwork.org or visit ClinicalTrials.gov and search identifier NCT04470427 to find a study center to volunteer. ClinicalTrials.gov includes a complete listing of study locations.Information from the National Institutes of Health
SAVANNAH, Georgia – The first Phase III clinical trial of a coronavirus vaccine began yesterday, and the government needs volunteers to research its effectiveness.
The first volunteer was injected with the investigational coronavirus vaccine known as mRNA-1273 yesterday morning in Savannah, Georgia. Dr Anthony Fauci, the Director of the National Institute of Allergy and Infectious Diseases (NIAID) hopes as many as 15,000 volunteers will be in place by the end of the week. The full trial is expected to recruit at least double that number, requesting approximately 30,000 adult volunteers who do not have COVID-19 to take part in the research.
The potential vaccine will be tested at approximately 89 clinical research sites in the country. Investigators will use public health data and incidence trajectory modeling to identify ‘hot zones’, or known vectors of contagion. This information will allow the trial to prioritized volunteer enrollment near the most severely impacted areas of the country.
Hope on the horizon
It will take months to learn if the vaccine produces the desired immune response, but a clinical trial only reaches Phase III after Phases I and II are deemed successful, so perhaps hope is truly on the horizon.
“Results from early-stage clinical testing indicate the investigational mRNA-1273 vaccine is safe and immunogenic, supporting the initiation of a Phase III clinical trial”, said Dr. Anthony Fauci. “This scientifically rigorous, randomized, placebo-controlled trial is designed to determine if the vaccine can prevent COVID-19 and for how long such protection may last.”
The Phase III trial is designed to evaluate several key factors. The primary goals are to confirm the safety of the vaccine and determine if it can prevent symptomatic COVID-19 after two doses. Secondarily, the trial will determine whether the vaccine can prevent severe COVID-19 and death caused by COVID-19, as well as prevent symptomatic COVID-19 with just one dose (as opposed to the two-doses experts currently anticipate).
The right goal for the American People
The mRNA-1273 vaccine was co-developed by Moderna, Inc., a Massachusetts-based biotechnology developer, and the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health. The NIH Coronavirus Prevention Network (CoVPN), assembled from existing NIAID-approved clinical research networks, will assist in conducting the trial.
Moderna, Inc. is leading the trial as both the regulatory sponsor and vaccine supplier. The Biomedical Advanced Research and Development Authority (BARDA) and NIAID are providing funding for this, the first trial to be implemented under Operation Warp Speed, a multi-agency collaboration that “aims to accelerate the development, manufacturing, and distribution of medical countermeasures for COVID-19”.
“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” said NIH Director Francis S. Collins, M.D., Ph.D. “The launch of this Phase III trial in record time while maintaining the most stringent safety measures demonstrates American ingenuity at its best and what can be done when stakeholders come together with unassailable objectivity toward a common goal.”