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Shortage of vaccines: USA, Europe, who next?
  1. Ulrich Heininger, European Editor

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We are all aware of the merits of preventing infectious diseases by vaccines and many of us have witnessed impressive examples of successful immunisation strategies: for example, the global eradication of smallpox, the elimination of poliomyelitis in most countries of the world, and the substantial decline of invasive Hib disease in the western world.

However, safety questions raised about certain vaccines—whether true (intussusception associated with rotavirus vaccine) or false (autism due to MMR)—have challenged paediatricians. Nowadays, it frequently requires long discussions, pronounced powers of persuasion and patience to convince parents about the benefits of vaccines. As if this were not enough, a further crisis has arisen: vaccine supplies are running short and/or the range of available vaccines is shrinking in the USA and several European countries. According to the Centers for Disease Control and Prevention, 8 of the 11 routine childhood vaccines are currently in short supply in the US, namely diphtheria, tetanus, and pertussis (DTPa); measles, mumps, rubella (MMR); varicella; and the pentavalent pneumococcal conjugate. The large demand for polysaccharides to be included in the latter may even negatively influence the availability of the familiar 23-valent pneumococcal polysaccharide vaccine, indicated for individuals aged 2 years or older with chronic diseases. In some European countries, formerly available “orphan vaccines” such as DT (without pertussis component) or monovalent diphtheria toxoid with reduced antigen content (“adult formulation”) have disappeared.

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How could this happen? Several recent mergers of pharmaceutical companies have led to market consolidation. Only a few “global players” are still manufacturing vaccines and their perceived duty to shareholders have resulted in some ceasing to produce less profitable vaccines. Similarly, former state owned or subsidised vaccine manufacturers are increasingly being forced to show a profit. Unfortunately, inspections of some plants by regulatory authorities have revealed failures to maintain quality standards as set by GMP guidelines (“good manufacturing practice”). These have led to interruptions of production, thus intensifying the supply shortfall. Further, increasing numbers of different antigen components in modern vaccines make it more and more likely that a given production lot might not fulfil quality criteria for all ingredients.

What is the way out of this dilemma? Logically, the more manufacturers of standard vaccines there are, the less likely is significant shortage of supply. Furthermore, companies producing vaccines should be required to announce ahead of time any withdrawal of vaccines from the market thereby allowing other manufacturers to increase their output. States should consider long term contracts with vaccine manufacturers to assure sufficient supply for their population and, perhaps most importantly, local vaccine producers in less developed countries need to be strongly supported to maintain or increase their output with respect to quality and quantity. The children of the world (and their parents) deserve no less.

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