EDITORIAL REVIEWS
Product Description A Warning Shot is a story of paradoxes. It is about the failure of government regulatory oversight as well as the heroic efforts of public health officials to respond to the crisis. It is the story of catastrophic production failure at one company and the work of others to fill the void. It is a tale about the failure of national leadership to protect our nation’s vaccine supply at a time when many of these same leaders were taking great care to prepare for a potential pandemic influenza.
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Praise and summary from JAMA This informative monograph, directed at the general public, uses anecdotes to illustrate many of the problems associated with the influenza vaccine shortage of 2004. The first section, tangential to the main topic, describes the 1918 influenza pandemic. The next two sections get back on track by presenting a short history of the development of influenza vaccine followed by a description of current production methods. Regulatory burden has led many manufacturers to withdraw from producing vaccines. By 2004, only three companies were licensed to sell influenza vaccines in the United States. The author discusses the globalization of vaccine production. Some US-based production facilities are owned by foreign companies, and US companies have production facilities outside our boundaries. This obviously complicates oversight by the US Food and Drug Administration (FDA). On October 5, 2004, the sudden announcement that the Chiron vaccine, which constituted almost half the US supply, would not be available caught US policy makers by complete surprise. The chaos and confusion that followed are well described. (excerpt from extensive review in JAMA) W. Paul Glezen, MD Baylor College of Medicine Houston, Tex January 11, 2007