Peter Marks, MD, PhD, directs the US FDA's Center for Biologics Evaluation and Research (CBER) and will "call the balls and strikes" on any COVID-19 vaccine, according to FDA Commissioner Stephen Hahn. He joins JAMA Editor Howard Bauchner, MD, for an update on vaccine progress to date and prospects for pre-election political interference in the FDA approval process. Recorded October 5, 2020. Related Article(s): Unwavering Regulatory Safeguards for COVID-19 Vaccines