National Academies Press: OpenBook

Adverse Effects of Pertussis and Rubella Vaccines (1991)

Chapter:Afterword on Research Needs

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Suggested Citation:"Afterword on Research Needs." Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/1815.
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Afterword on Research Needs

In the course of its review, the committee found many gaps and limitations in knowledge bearing directly and indirectly on the safety of vaccines. Such shortcomings relate, for example, to pathologic mechanisms of specific infectious agents, the molecular basis of vaccine injury, and the natural history of conditions such as encephalopathy, mental retardation, and chronic arthritis. Many of the reports of case series suffer from inadequate or inconsistent case definitions, variable details about cases, inclusion of nonrepresentative case groups, and failure to consider potential confounding variables or biases. In addition, existing surveillance systems of vaccine injury have limited capacity to provide persuasive evidence of causation. Many of the population-based epidemiologic studies are too small or have inadequate lengths of follow-up to have a reasonable chance of detecting true adverse effects, unless these effects are large or occur promptly and consistently after vaccination. If research capacity and accomplishment in this field are not improved, future reviews of vaccine safety will be similarly handicapped.

The committee found few experimental studies published in relation to the number of epidemiologic studies published. As noted in Chapter 2, withholding of vaccines can be regarded as unethical. Although the committee was not charged with, and has not attempted, full consideration of the kinds of studies that would be both ethical and especially informative, either in the areas of vaccines that it has been charged to study or more

Suggested Citation:"Afterword on Research Needs." Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/1815.
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Page 207

generally, it recognizes, nevertheless, that opportunities may exist for informative experiments in human populations that take advantage of the possibility of using alternative schedules for administration of vaccines.

A careful review is needed to identify what sorts of questions might be best answered by further investigations and which kinds of studies could be carried out economically. The availability and introduction of new forms of pertussis vaccine, for example, could offer valuable opportunities for comparison of vaccine safety as well as efficacy. The committee is not in a position to make specific recommendations, but its experience points to fresh possibilities and to the need for such a review.

Suggested Citation:"Afterword on Research Needs." Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/1815.
×
Page206
Suggested Citation:"Afterword on Research Needs." Institute of Medicine. 1991. Adverse Effects of Pertussis and Rubella Vaccines. Washington, DC: The National Academies Press. doi: 10.17226/1815.
×
Page207
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Adverse Effects of Pertussis and Rubella Vaccines Get This Book
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Parents have come to depend on vaccines to protect their children from a variety of diseases. Some evidence suggests, however, that vaccination against pertussis (whooping cough) and rubella (German measles) is, in a small number of cases, associated with increased risk of serious illness.

This book examines the controversy over the evidence and offers a comprehensively documented assessment of the risk of illness following immunization with vaccines against pertussis and rubella. Based on extensive review of the evidence from epidemiologic studies, case histories, studies in animals, and other sources of information, the book examines:

  • The relation of pertussis vaccines to a number of serious adverse events, including encephalopathy and other central nervous system disorders, sudden infant death syndrome, autism, Guillain-Barre syndrome, learning disabilities, and Reye syndrome.
  • The relation of rubella vaccines to arthritis, various neuropathies, and thrombocytopenic purpura.

The volume, which includes a description of the committee's methods for evaluating evidence and directions for future research, will be important reading for public health officials, pediatricians, researchers, and concerned parents.

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