The Anthrax Vaccine Is It Safe? Does It Work? (2002) / Chapter Skim
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5 Safety: Case Reports
5 Safety: Case Reports
Pages 102-117
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From page 102... ...
The committee identified two published case reports related to Anthrax Vaccine Adsorbed (AVA; Kerrison et al., 2002; SwansonBicarman and Krenzelok, 2001~. The most extensive collection of case reports of adverse events following vaccination is contained in the Vaccine Adverse Event Reporting System (VAERS)
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From page 103... ...
VAERS Reporting Process VAERS receives spontaneous reports of adverse events following vaccination. From 1990, when VAERS began, through December 2001, VAERS received more than 126,000 reports on events associated with vaccines of all types (Iskander, 2002~.
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From page 104... ...
Reports are submitted to the VAERS contractor, who acknowledges their receipt with a letter to the reporter (Chen et al., 1994; Singleton et al., 1999~. The contractor assigns a unique identifier to each report, assigns codes to the adverse events reported, and enters the data into a computer database.
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From page 105... ...
Review of VAERS Data by FDA and CDC Both FDA and CDC regularly review data from VAERS reports for patterns in the data that suggest the possibility of previously unrecognized adverse events. For regulatory purposes, FDA reviews individual reports to assess whether the reported events are adequately reflected in product labeling (FDA, 2001~.
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From page 106... ...
A numerator based on the number of reports can be assumed to differ from the true number of events, and there are no data on the total number of doses administered for the denominator (Mootrey, 2000; Singleton et al., 1999; Tilson, 1992~. In the case of AVA, however, DoD has maintained records on vaccine doses administered since the start of the Anthrax Vaccine Immunization Program (AVIP)
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From page 107... ...
. Submission of VAERS Reports DoD, which administers most of the anthrax vaccine used in the United States, has a central role in the reporting of any adverse events that occur following vaccination.
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From page 108... ...
Copies of VAERS reports must also be submitted to a service's reportable disease officer within 7 days of an adverse event. Concerns About Reporting to VAERS Some service members have expressed concern that they have been discouraged from submitting VAERS reports regarding the anthrax vaccine.
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From page 109... ...
However, the submission of reports to VAERS should not be restricted to visits assigned codes that identify them as potentially vaccine related. DoD Access to and Use of VAERS Data The AVIP Agency, which is part of DoD, monitors VAERS reports related to the use of AVA.
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From page 110... ...
. AVEC reviews AVA-related VAERS reports individually to assess the probability of a causal relationship between the reported adverse event and the anthrax vaccine and in aggregate to determine if any patterns are evident from the reports.
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From page 111... ...
. Should information from VAERS reports raise such concerns, AVEC would inform the National Vaccine Injury Compensation Program, which would
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From page 112... ...
AVEC has reviewed a total of 1,623 unique VAERS reports about adverse events following receipt of the anthrax vaccine. This section provides summary information about the nature of the events reported to VAERS, the conclusions reached by AVEC as to the likelihood of a causal association between vaccination with AVA and the reported adverse event, allergic reactions reported through VAERS, and the IOM committee's conclusions from its own review of the VAERS reports concerning serious adverse events (i.e., a death, a life-threatening illness, or an illness that results in a permanent disability, hospitalization, or prolongation of a hospital stay)
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From page 113... ...
SAFETY: CASE REPORTS 113 TABLE 5-1 AVEC Classification of Hospitalizations Reported to VAERS (as of October 2, 2001) Following Anthrax Vaccination and Not Classified as "Very Likely/Certainly" or "Probably" Caused by Anthrax Vaccine Adsorbed Number of VAERS Reports Diagnosis Unclassifiable Unrelated Unlikely Possible Abdominal pain Acute encephalitis Angioedema Aplastic anemia Atrial fibrillation B-cell lymphoma involving central nervous system Bipolar psychiatric disorder Blackout episode Cardiac arrest Cardiomyopathy with atrial fibrillation Diabetes mellitus, insulin requiring Diabetes mellitus, non-insulin requiring Dysesthesias (T1 and below)
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From page 114... ...
Involving Loss of Time from Duty of 24 Hours or More and Considered by AVEC as Certainly or Probably Caused by Anthrax Vaccine Adsorbed Reported Adverse Event Number of Events I
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From page 115... ...
2001. Section J: Reports involving anthrax vaccine submitted to tI7e FDA/CD C Vaccine Adverse Event Reporting System (VAERS)
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From page 116... ...
2001. Statement and documents submitted for the Joint Meeting of the Institute of Medicine Committee to Assess the Safety and Efficacy of the Anthrax Vaccine and the Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program, Meeting III, Washington, D.C.
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From page 117... ...
Presentation to the Joint Meeting of the Institute of Medicine Committee to Assess the Safety and Efficacy of the Anthrax Vaccine and the Institute of Medicine Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program, Meeting III, Washington, D.C. Tilson H
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