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The US Food and Drug Administration (FDA) will likely issue emergency use authorizations for 2 vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), one developed jointly by Pfizer and BioNTech and the other by Moderna. According to company press releases and data made available by the FDA,1 both vaccines have shown approximately 95% efficacy in preventing symptomatic COVID-19 infections in phase 3 trials, without significant safety concerns that might hinder authorization by the FDA. Additional phase 3 trials of vaccines manufactured by Janssen and AstraZeneca are underway; with rapidly rising case counts in the US, initial results from those trials may not be far behind. All of these trials compare the incidence of symptomatic infection among vaccine recipients with that among a placebo control group. However, once authorized vaccines become widely available, conducting placebo-controlled trials of subsequent vaccine candidates may become challenging.2 Alternative strategies to evaluate those vaccines, and to compare their safety and efficacy with those of authorized products, are needed.
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Corresponding Author: Steven Joffe, MD, MPH, Department of Medical Ethics and Health Policy, University of Pennsylvania Perelman School of Medicine, 423 Guardian Dr, BH1413, Philadelphia, PA 19104 (firstname.lastname@example.org).
Published Online: December 14, 2020. doi:10.1001/jama.2020.25127
Conflict of Interest Disclosures: Dr Joffe is a member of the independent data and safety monitoring board responsible for oversight of SARS-CoV-2 clinical trials supported by Operation Warp Speed, for which he receives an honorarium of $200 per meeting from the National Institute of Allergy and Infectious Diseases. He received research funding from Pfizer through the University of Pennsylvania until May 2020.
Disclaimer: The views expressed here are the author’s own and do not necessarily reflect those of the DSMB or of any of the entities with which it is affiliated.
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