Adverse Effects of Vaccines Evidence and Causality (2012) / Chapter Skim
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13 Concluding Comments
13 Concluding Comments
Pages 629-634
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From page 629... ...
Determining the rate of specific adverse events following immunization, in the general population or a subset thereof, is challenging. It would be possible, for example, to estimate a rate of the occurrence of a specific adverse effect in a vaccinated population or susceptible subgroup of interest.
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From page 630... ...
for the study's relative risk or absolute risk difference could be estimated, but one would be unable to rule out a possibly increased risk unless the vaccine was significantly protective against that particular adverse effect. Also, including such studies may have exacerbated problems with detection biases unless precautions were taken to ensure equal surveillance for the adverse event in the unvaccinated and vaccinated populations being compared.
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From page 631... ...
Anaphylaxis: Although it is also difficult to estimate rates for very rare conditions, the committee concluded that evidence supports the association of anaphylaxis with certain vaccines in certain circumstances, but the number of events related to each specific vaccine is not known. Rates can be estimated from surveillance studies, but often specific details are missing, and each case cannot be linked with certainty to vaccine.
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From page 632... ...
Anaphylactic reactions to several vaccines are likely caused by the presence of components introduced during manufacturing, such as egg protein, milk protein, or gelatin. When a specific inciting component of the vaccine has been identified and the manufacturers find ways to remove or drastically reduce the amount of the reactive antigen (e.g., egg protein in influenza vaccine)
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From page 633... ...
The committee does want to emphasize many of the adverse events examined are exceedingly rare in the population overall, and in most instances any particular adverse event, be it arthritis, meningitis, or any of the other vaccine–adverse events that the committee considered, are not preceded by immunization. The committee chose cautious and scientific language for our conclusions, because, especially with rare events, it is not possible to prove a negative (i.e., the vaccine did not and cannot cause the event)
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From page 634... ...
2004. MMR vaccination and febrile seizures: Evaluation of suscepti ble subgroups and long-term prognosis.
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