Adverse Events Associated with Childhood Vaccines Evidence Bearing on Causality (1994) / Chapter Skim
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Appendix B: Strategies for Gathering Information
Appendix B: Strategies for Gathering Information
Pages 318-334
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librarian in the winter of 1992, with follow-up searches for newly published literature carried out in August 1992, December 1992, and March 1993. Table B-1 lists the vaccine and adverse event combinations that were under consideration by the committee and that formed the basis of the search strategies.
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In addition to the initial searches of vaccine and adverse event combinations (Table B-1) , the committee requested searches of the following at
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In all, about 150 items were translated from 18 languages. A bibiliography of references cited in the report and organized both by vaccine and by adverse event entitled "Bibliography of Adverse Consequences Associated with Childhood Vaccines" is available from the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia 22161 (703-487-46501.
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REVIEW OF INTERIM BIBLIOGRAPHY Midway through the project (December 1992) , an interim bibliography of the more than 1,600 citations being reviewed by the committee was sent to 22 individuals representing a range of views on the topic of adverse events following vaccination.
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Health care providers are obligated to report specific adverse events following particular vaccines, as set out in a Vaccine Injury Table also established under the Vaccine Injury Act. Parents, other relatives, or anyone aware of the occurrence of an adverse event may also file a report with VAERS.
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to report reactions to vaccines listed in She vaccine Injury Table. Reports for reactions to other vaccines are voluntary except when required as a condition Ot immunization grant awards.
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These data will be used to increase understanding of adverse events following vaccination and will become part of CDC Privacy Act System 09-20-0136, t`Epidemiologic Studies and Surveillance of Disease Problems". Information identifying the person who received the vaccine orthat person's legal representative will not be made available to the public, but may be available to the vaccines or legal representative.
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, circumstances for delaying the administration of a vaccine, and potential high-risk groups for adverse events following vaccination. She asked the committee to be conscientious about reviewing adverse events that were not a part of its original charge, if the evidence should warrant such a review.
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Committee members were present at the sessions and were provided with full transcripts of the meetings afterward. (Transcripts may be purchased from the National Technical Information Service, 5285 Port Royal Road, Springfield, Virginia, 22161; 703-487-4650.)
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He noted that the National Vaccine Injury Compensation Program must take into account the possibility of post-polio syndrome when developing compensation plans for those who contract polio from the oral vaccine. Jesse Ferguson, Milwaukee, Wisconsin Mr.
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manufactured in the 1950s caused polio disease in addition to those cases reported as part of the well-known Cutter incident. He suggested that polio following IPV should be an adverse event listed in the Vaccine Injury Table of the National Vaccine Injury Compensation Program.
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O Presentations, January 16, 1993, Irvine, California John Brydon, attorney, Long Beach, California Mr. Brydon expressed concern about whether the inactivated polio vaccine produced in the l950s adequately inactivated the poliovirus.
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Hugo questioned the arbitrary time criteria used by the compensation program for determining the relationship between a vaccine and an adverse event, noting that events that fall outside the guidelines by only a few hours are not compensated, are returned to the jurisdiction of the civil courts, and thus result in more lawsuits. He called for the biologic variability of individuals to be taken into account so that the Vaccine Injury Table guidelines would not be considered as rigid rules.
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and expressed a wish that the current committee would avoid the same problems, such as acceptance of studies with flawed designs, improper definitions of control groups, and risk estimates based on the number of doses of vaccine rather than on the number of children vaccinated. She expressed concern about measles vaccine and the possibility that widespread vaccination has increased the case fatality rate for those cases of measles that do occur.
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Bonnie Plumeri Franz, Ogdensburg, New York. Letter regarding concerns about the adequacy and accuracy of research relating to adverse events following receipt of vaccines.
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Centers for Disease Control. Adverse Events Following Immunization: Surveillance Report No.
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