Mayo Clinic Q&A: FDA Sets Stricter Standards for COVID-19 Vaccine Development

In an effort to reassure the public about the safety and effectiveness of a vaccine, the Food and Drug Administration has set stricter standards for COVID-19 vaccine development. These standards include following phase 3 clinical trial participants for at least two months, and having at least five severe COVID-19 cases in the placebo group. The agency's requirements are designed to ensure that there is adequate safety data on any vaccine before it is authorized for emergency use. (Published 10/14/2020)