Title : Monitoring the Data on Covid-19 Vaccines: The Challenges by Susan Ellenberg, University of Pennsylvania
Susan Ellenberg, University of Pennsylvania 
Ivan S. F. Chan

Abstract: Vaccines to protect against the worldwide COVID-19 pandemic were developed in an astoundingly short time.  The rapid sequencing of the virus SARS-COV-2 allowed vaccine manufacturers to formulate vaccine candidates very quickly, and after initial phase 1 studies were able to launch large scale trials by July 2020, only 6 months after the virus was initially identified.  Five vaccine candidates were selected by the U.S. government for “Operation Warp Speed;” trials of these vaccines were conducted with the involvement of the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority, and were overseen by a single Data and Safety Monitoring Board (DSMB).  The Board faced a number of challenges during the monitoring process, primarily due to the urgent need for safe and effective vaccines, and to the fact that each vaccine manufacturer contracted with its own independent statistical/data management groups to perform interim analyses and present them to the DSMB.

Following the Emergency Use Authorization of vaccines shown to be safe and effective in the clinical trials, the vaccines were rapidly deployed; and just as rapidly, misinterpretation of the emerging post-marketing safety data entered into circulation.  In this presentation I will discuss the challenges of monitoring the vaccines both prior to and after the vaccines became available to the public.


Instructors’ Biography:

Dr. Ellenberg’s research has focused on practical problems and ethical issues in designing, conducting and analyzing data from clinical trials, including surrogate endpoints, data monitoring committees, clinical trial designs, adverse event monitoring, vaccine safety and special issues in cancer and AIDS trials. At Penn, in addition to her teaching and administrative duties she serves as senior statistician for several multicenter clinical trials and directs the Biostatistics Core of the Penn Center for AIDS Research.  She chairs the organizing committee for the annual Penn conference on statistical issues in clinical trials. She also served for many years as Associate Dean for Clinical Research, overseeing the human subjects protections programs, training and centralized research support of the Perelman School of Medicine.

Prior to her appointment at Penn, Dr. Ellenberg held positions of increasing responsibility in the federal government. From 1993 to 2004, she served as Director, Office of Biostatistics and Epidemiology in the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration; prior to that she served as the first Chief of the Biostatistics Research Branch in the Division of AIDS, National Institute of Allergy and Infectious Diseases (1988-1993), and served in the Biometric Research Branch in the Cancer Therapy Evaluation Program, National Cancer Institute (1982-1988).

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