FDA’s SARS-CoV-2 vaccine review needs major dose of transparency

As the federal government’s “Operation Warp Speed” works to quickly deliver a safe, effective vaccine to protect against SARS-CoV-2 infection, the AMA is calling for a big boost in the transparency of the process.

“With COVID-19 vaccine development moving at a rapid pace, it is critical that we ensure physicians are continuously informed of the U.S. Food and Drug Administration’s (FDA) plans for review and that they are provided with the utmost level of transparency regarding the process for authorization or licensure, standards for review, and safety and efficacy data as soon as possible,” AMA Executive Vice President and CEO James L. Madara, MD, wrote in a letter or FDA Commissioner Stephen Hahn, MD.

My latest for the AMA. The whole shebang.