FROM THE WASHINGTON POST
FDA commissioner: No matter what, only a safe, effective vaccine will get our approval
Stephen M. Hahn, a physician, is commissioner of the Food and Drug Administration.
Since the outbreak of the covid-19 pandemic, developing a safe and effective vaccine has been an urgent worldwide priority: to save lives, and to bolster the public’s confidence in returning to a semblance of normal life.
At the Food and Drug Administration and our parent agency, the Department of Health and Human Services, we recognize the vital importance of vaccine development. The framework in the United States to support a covid-19 vaccine is now in place. Testing is underway and manufacturing capacity is rapidly expanding. But let’s be clear: The development effort must adhere to standards that will ensure any covid-19 vaccine’s safety and effectiveness.
Large-scale clinical trials already have begun for several promising vaccine candidates. The data from these trials will enable the scientists at the FDA to determine which of these candidates has the greatest potential to provide protection from the virus, what the possible side effects are and how long immunity is likely to last. FDA scientists will need the information to decide whether approval of the vaccine for general use is justified. This fall, we expect to start identifying which vaccine candidates are truly viable.