key: cord-0883866-prwa48yp
authors: Corey, Lawrence
title: Behind the Scenes Heroes: the COVID-19 Vaccine Data and Safety Monitoring Board
date: 2021-05-19
journal: J Infect Dis
DOI: 10.1093/infdis/jiab267
sha: f9b88b9d3cedb64e450cc3dcc5fc14240790771f
doc_id: 883866
cord_uid: prwa48yp

nan

of explaining the Board's charter and responsibilities but, most importantly, the workings and enormous responsibility of this committee. By way of full disclosure, I was one of the people who felt a single independent DSMB was an essential requirement for the framework of utilizing independently conducted harmonized clinical trials to evaluate COVID-19 vaccines. We did so for reasons the authors articulated in the article to "facilitate informed judgments about the interim analysis;" to provide an independent evaluation of adverse events and, perhaps most importantly, that individual trials would benefit from insights from the complete trial portfolio (ref 2). These statements and the rather dry comment that the group met once a week for two to three hours and ad hoc as needed are major understatements of the effort and wisdom required to perform these tasks.

The COVID-19 vaccine trials that the DSMB oversaw were remarkable in their size and pace. Each trial enrolled from 30,000 to 45,000 persons in 8-10 weeks; on some days, over 2000 persons were enrolled in a single trial (refs 3-5) . The entire country participated in the program, and between 90 and 140 clinical trial sites were utilized for each trial. The trials were staggered at a pace of essentially one 30,000-person trial per month and, hence, as of today, the Board has under review 4 30,000-45,000 persons trials with another scheduled to start in late May 2021 (refs 3-6). Each trial is designed to go for 24 months and, therefore, their job will not be over until late 2023 (ref 7). The trials, while designed to be streamlined, were far from simple, for COVID-19 is not a simple disease. The data from the trials have formed the basis for the remarkable vaccine rollout we are now experiencing. This DSMB was central to all of these events. Perhaps this article will initiate some future dialogue about the issues outlined in the prior paragraph. I hope such deliberations occur.

What is certain now is how central this group of colleagues were to the success of the COVID vaccine clinical trials enterprise. To paraphrase Winston Churchill, we would say, "Never have so many of us in investigative medicine owed so much to so few." (ref 9) All of us should thank these men and women who assisted in this effort; we owe them our gratitude.

The author has no conflicts of interest to declare and reports funding from NIAID UM1 AI068614-14. The author thanks Dr. Mindy Miner for editorial assistance.

A c c e p t e d M a n u s c r i p t 5

Broder B and the CoVPN Community Engagement Team. Utilizing a Robust HIV Prevention Framework to Engage Communities in COVID-19 Prevention Efforts. Oral Presentation. HIV Research for Prevention (R4P)

speech to the House of Commons