A leading Food and Drug Administration (FDA) official contended in 1999 that modern advances in vaccine technology were rapidly “outpacing researchers” ability to predict potential vaccine-related adverse events” and argued for closer attention to safety issues from the earliest stages of vaccine development. “One of the important things is that the technology used to make these vaccines actually exceeds the science and technology to understand how these vaccines work and to predict how they will work,” stated Dr. Peter Patriarca, MD, Director of the Viral Products Division of the FDA Center for Biological Evaluation and Research (CBER). “So this has the potential for ending up in a situation which I call a “black box” vaccine” referring to a situation of unforeseen and unpredictable vaccine outcomes.”
Dr. Patriarca also voiced concerns…
