Find the latest COVID-19 news and guidance in Medscape’s Coronavirus Resource Center.
FDA experts evaluate three main areas for all vaccines, including for COVID-19: safety, effectiveness, and manufacturing quality.
Before a COVID-19 vaccine is approved, the FDA will review safety and effectiveness data from at least one well-designed and -performed clinical trial that shows data that are “clear and compelling.”
The FDA is looking for a COVID-19 vaccine that has a minimum of 50% efficacy but is hoping for higher.
The FDA is requiring a “very robust” program to continue to look at safety data after a COVID-19 vaccine is approved, as well as an “aggressive” postmarketing assessment program.
This transcript has been edited for clarity.
John Whyte, MD, MPH: You’re watching Coronavirus in Context. I’m Dr John Whyte, chief medical officer at WebMD. Today I am joined by Dr Stephen Hahn. He’s the commissioner of the US Food