Adverse Events Associated with Childhood Vaccines Evidence Bearing on Causality (1994) / Chapter Skim
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1 Executive Summary
1 Executive Summary
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Concern has stretched to other vaccines and has spawned the formation of groups of interested citizens throughout the United States, for example, National Vaccine Information Center/Dissatisfied Parents Together, Determined Parents to Stop Hurting Our Tots, Concerned Health Professionals and Others, and Parents
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In addition to establishing the compensation program, the NCVIA set forth other vaccine-related efforts to be carried out by the U.S. Department of Health and Human Services, including mandatory reporting of specific adverse events following childhood immunizations against diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio (see box entitled The Vaccine Injury Table in Chapter 101; voluntary reporting of any reaction to any immunization to the Vaccine Adverse Event Reporting System (see Chapter 10 for a discussion of this passive surveillance system and Figure B-1 for a copy of the reporting form)
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Like the Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, the Vaccine Safety Committee approached its task from a position of neutrality, presuming neither the presence nor the absence of a causal relation between the vaccines and the adverse events under consideration. THE STUDY PROCESS Over the course of 18 months, the committee met six times, reviewed more than 7,000 abstracts of scientific and medical studies, read more than 2,000 published books and articles (including many sources in the non
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Appendix A contains the Executive Summary of that report. The charge to the Vaccine Safety Committee was to examine adverse events associated with tetanus toxoid as well as tetanus and diphtheria toxoid combination preparations.
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A common combination, as a result of the immunization schedules recommended in the United States, is DPT, oral polio vaccine, and Hib vaccine. Assessment of causality in those reports was more difficult than if the patient had received only one vaccine or vaccine component, but the committee considered that the reports could be theoretically supportive of causality for the combination but not in themselves sufficient to allow a firm judgment regarding causality.
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The evidence favors rejection of a causal relation between: diphtheria and tetanus toxoids and encephalopathy,e infantile spasms,J and death from sudden infant death syndrome (SIDS) fg and conjugate Hib vaccines and early-onset Hib disease.
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Work in these areas will help to ensure that all vaccines used are as free from the risk of causing adverse events as possible. Some of the needs identified are for increased surveillance of reports of demyelinating disease and arthritis following hepatitis B vaccination, better follow-up of reports of death and other serious adverse events following vaccination, increased use of large databases (currently used only on a small scale)
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ADVERSE EVENTS ASSOCIATED WITH CHILDHOOD VACCINES er BL.
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