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Adverse Effects of Vaccines: Evidence and Causality

The Institute of Medicine (IOM) of the National Academies

Using epidemiologic and mechanistic evidence, the committee developed 158 causality conclusions and assigned each relationship between a vaccine and an adverse health problem to one of four categories of causation:

  • Evidence convincingly supports a causal relationship
  • Evidence favors acceptance of a causal relationship
  • Evidence favors rejection of a causal relationship
  • Evidence is inadequate to accept or reject a causal relationship

The committee finds that evidence convincingly supports a causal relationship between some vaccines and some adverse events—such as MMR, varicella zoster, influenza, hepatitis B, meningococcal, and tetanus-containing vaccines linked to anaphylaxis. Additionally, evidence favors rejection of five vaccine-adverse event relationships, including MMR vaccine and autism and inactivated influenza vaccine and asthma episodes. However, for the majority of cases (135 vaccine-adverse event pairs), the evidence was inadequate to accept or reject a causal relationship. Overall, the committee concludes that few health problems are caused by or clearly associated with vaccines.

Abstract with link to Full paper.

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