FDA issues vaccine development guidance, authorizes new molecular-based COVID-19 test
The Food and Drug Administration yesterday for the development of a SARS-CoV-2 vaccine, outlining key considerations to satisfy requirements for chemistry, manufacturing and control, nonclinical and clinical data.
The agency said the current goal of vaccine development programs should be 鈥渢o support traditional FDA approval by conducting studies to directly evaluate the ability of the vaccine to protect humans from SARS-CoV-2 infection and/or disease.鈥
FDA also authorized the emergency use of the molecular-based . The agency concluded that the qualitative test鈥檚 known and potential benefits outweigh the risks during the COVID-19 public health emergency.
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