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.
On the Mayo Clinic Q&A podcast, Dr. Gregory Poland, an infectious diseases expert and head of Mayo Clinic’s Vaccine Research Group, discusses vaccine development standards and shares concerns about the second wave of COVID-19 infections.
Information in this post was accurate at the time of its posting. Due to the fluid nature of the COVID-19 pandemic, scientific understanding, along with guidelines and recommendations, may have changed since the original publication date.