Safety board members describe stringent oversight of U.S. COVID-19 vaccine trials

In a new report published in the Journal of Infectious Diseases, the 11-member Data and Safety Monitoring Board (DSMB) that is overseeing the federally funded COVID-19 vaccine trials outlines its mission, procedures, and the challenges that it faced in monitoring these trials during the pandemic.

The report details how the DSMB approach can serve as a model for future situations in which there is an urgent need for coordinated development of multiple therapeutic or preventive interventions to address rapidly evolving public health threats.

Steven Joffe, MD, MPH, the interim chair of the Department of Medical Ethics & Health Policy at the Perelman School of Medicine at the University of Pennsylvania, is the report’s lead author, and Susan Ellenberg, PhD, a professor of Biostatistics, Medical Ethics and Health Policy at Penn co-authored the report. Both served on the DSMB.

Joffe says:

“Given the scope of the COVID-19 pandemic and the multiple entities testing vaccines, we were charged with ensuring that the trials were run according to the highest standards of quality, that the safety of participants was paramount, and that decisions about whether the vaccines were effective were made with rigor and care. This task was challenging due to the large size and rapid pace of the trials and the political climate in which they took place.

“Because the DSMB operated behind the scenes, the public has heard very little about this crucial committee. It’s important for everyone to know that the DSMB reviews the data from the trials in detail, and we are confident that the vaccines were tested according to the highest standards, with patient safety, public health, and trust in the outcomes of the trials as our top priorities.”