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Evaluating SARS-CoV-2 Vaccines After Emergency Use Authorization or Licensing of Initial Candidate Vaccines

Educational Objective
To identify the key insights or developments described in this article
1 Credit CME

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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Article Information

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 (joffes@upenn.edu).

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.

References
1.
Vaccines and Related Biological Products Advisory Committee December 10, 2020, meeting announcement. US Food and Drug Administration. Accessed December 9, 2020. https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-10-2020-meeting-announcement#event-materials
2.
Zimmer  C , Weiland  N . Should volunteers who got placebo be first to get the real thing? New York Times. December 3, 2020:A7.
3.
Statement on continuation of vaccine trials. International Coalition of Medicines Regulatory Authorities. Published 2020. Accessed December 2, 2020. http://www.icmra.info/drupal/covid-19/statement_on_continuation_of_vaccine_trials
4.
WHO Ad Hoc Expert Group on the Next Steps for Covid-19 Vaccine Evaluation.  Placebo-controlled trials of Covid-19 vaccines—why we still need them.   N Engl J Med. Published online December 2, 2020. doi:10.1056/NEJMp2033538Google Scholar
5.
Goodnough  A. Everything you wanted to know about the shot. New York Times. December 3, 2020:A7.
6.
Center for Biologics Evaluation and Research. Development and licensure of vaccines to prevent COVID-19: guidance for industry. US Food and Drug Administration. Published June 2020. Accessed December 2, 2020. https://www.fda.gov/media/139638/download
7.
Avorn  J , Kesselheim  A .  Regulatory decision-making on COVID-19 vaccines during a public health emergency.   JAMA. 2020;324(13):1284-1285. doi:10.1001/jama.2020.17101PubMedGoogle ScholarCrossref
8.
Temple  R , Ellenberg  SS .  Placebo-controlled trials and active-control trials in the evaluation of new treatments, part 1: ethical and scientific issues.   Ann Intern Med. 2000;133(6):455-463. doi:10.7326/0003-4819-133-6-200009190-00014PubMedGoogle ScholarCrossref
9.
Angus  DC .  Optimizing the trade-off between learning and doing in a pandemic.   JAMA. 2020;323(19):1895-1896. doi:10.1001/jama.2020.4984PubMedGoogle ScholarCrossref
10.
Angus  DC , Derde  L , Al-Beidh  F ,  et al; Writing Committee for the REMAP-CAP Investigators.  Effect of hydrocortisone on mortality and organ support in patients with severe COVID-19: the REMAP-CAP COVID-19 Corticosteroid Domain randomized clinical trial.   JAMA. 2020;324(13):1317-1329. doi:10.1001/jama.2020.17022PubMedGoogle ScholarCrossref
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