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Research Strategies for Assessing Adverse Events Associated with Vaccines A Workshop Summary (1994) / Chapter Skim
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Pages 16-19

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From page 16...
... Recent experience indicates that these populations are suspicious of the true intent of the study, believing that it is a trial of a harmful substance or procedure. Clinical trials for evaluating vaccine efficacy generally do not include sufficient sample sizes to permit adequate evaluations of the risk of adverse reactions.
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From page 17...
... There was concern by some that unvaccinated individuals are so different from vaccinated individuals that these differences cannot be controlled for; that is, completely unvaccinated individuals might possess other health or socioeconomic traits if they are from a population that does not believe in traditional medical treatments, or they might represent a limited gene pool if the population consists of a longstanding, religious sect. One participant argued that comparison with unvaccinated controls might make vaccines look more beneficial than they are, because those who are not vaccinated are more likely to be underprivileged or have more diseases or disorders for other reasons.
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From page 18...
... Adverse Events with Long Latencies Previous discussions examined the potential utility of case reports in assessing causality. This is particularly true for assessing the causalities of adverse events that occur shortly after vaccination.
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From page 19...
... Although technical advances are making it possible to isolate virus from the brains of patients with SSPE and type the RNA as being of the vaccine strain or the wild-type, the failure to isolate vaccine-strain virus does not prove that the vaccine cannot cause SSPE. As was articulated by the IOM committees (Institute of Medicine, 1991, 1994a)
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Key Terms

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  • measles vaccine
  • clinical trials
  • occurring adverse
  • background incidence

  • unvaccinated individuals
  • cause sspe
  • participant commented
  • assessing adverse
  • adverse reactions

  • assessing causality
  • acute outbreaks
  • helpful unless
  • vaccine strain
  • ecologic correlations

  • evaluating vaccine
  • participant noted
  • vaccinated children
  • particularly true
  • medical treatments

  • diabetes mellitus
  • infant mortality
  • participant stressed
  • vaccinated recently
  • gene pool

  • serious adverse
  • percent decrease
  • designed primarily
  • isolated virus
  • conducting studies


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