More than 40 percent of the United States population has now received at least one dose of a COVID-19 vaccine under emergency use authorizations from the Food and Drug Administration (FDA).
Full approval would also instill greater public confidence in the vaccine, says Dr. Adrian Hernandez, executive director of the Duke Clinical Research Institute (DCRI). He offers the following comments for use in your coverage.
“Full FDA approval of the three COVID-19 vaccines currently in use in the U.S. provides the next major step showing the confidence to the public on the substantial benefits versus risks of the vaccines. Full approval would also enable organizations to fully implement vaccination programs, as some organizations may be hesitant to require vaccination for their employees or community with only emergency use authorization,” says Dr. Adrian Hernandez, executive director of the Duke Clinical Research Institute.
“For the three COVID-19 vaccines that are currently in use in the U.S. under FDA emergency use authorization, all necessary clinical trial data has been collected and submitted, and the manufacturing process is complete. In regard to next steps in the approval process, it is now up to the FDA to independently review, replicate or validate data and meet all of the key steps for approval.”
“Because the development process for these vaccines was tightly coordinated with the FDA, we should be able to expect an abbreviated timeline for the approval process, which could take months off the overall time needed for a full approval. The typical FDA review takes about 10 months, but the goal for priority review is 6 months.”
“Each of the vaccines will have different questions that will require further evaluation within a trial or post-market settings, which should not impact the approval process. These questions could include benefits and risks in the context of emerging COVID-19 variants or incomplete dosing (one shot versus two). The vast majority of these questions will need to be addressed through long-term, longitudinal studies that collect real-world evidence, such as the HERO-TOGETHER study being conducted by the Duke Clinical Research Institute.”
Dr. Adrian Hernandez is the executive director of the Duke Clinical Research Institute (DCRI). Dr. Hernandez is a cardiologist and an internationally recognized leader in clinical research, ranging from clinical trials to health services and policy research. As the executive director of DCRI, he oversees institute to ensure the continuance of a broad spectrum of clinical research programs, clinical trials, clinical and pre-clinical education, and shared data and repositories. He has published over 600 articles and is an elected member of the American Society for Clinical Investigation and the Association of American Physicians.
For additional comment, contact Adrian Hernandez at:
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