Make Pre-Approval Covid-19 Vaccines Available Through Expanded Access, Not an EUA

November 9, 2020

(STAT News) – On Monday, Pfizer Inc. and BioNTech SE announced that their experimental Covid-19 vaccine candidate prevented more than 90% of infections in healthy volunteers. Based on these encouraging data — potentially among the most effective for any infectious disease — the companies plan to apply for emergency use authorization (EUA), which would let the U.S. Food and Drug Administration (FDA) formally authorize an unapproved medical product during a state of emergency. While well intentioned, this approach is ultimately misguided. The world faces a crisis not an emergency.