FDA sets stricter standards for COVID-19 vaccine development

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Oct 14, 2020 | Jennifer O'Hara | @jenohara

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

To practice safe social distancing during the COVID-19 pandemic, this interview was conducted using video conferencing. The sound and video quality are representative of the technology used.

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Dr. Poland has served as a consultant for Merck & Co. Inc., Medicago Inc., GlaxoSmithKline plc, Sanofi Pasteur, Emergent BioSolutions Inc., Dynavax Technologies Corp., Genentech Inc., Eli Lilly and Co., Kentucky BioProcessing Inc. and Genevant Sciences Corp., and Janssen Pharmaceuticals Inc. He is a paid scientific adviser for Johnson & Johnson. Honoraria: Elsevier.