and Rubella Vaccines made determinations of causality only for rubella vaccine and the rubella vaccine component of multivalent vaccines, but not for measles-mumps-rubella vaccine (MMR). Thus, the Vaccine Safety Committee reviewed data regarding immunization with MMR as well as data on monovalent measles and mumps preparations. The committee has made separate determinations of causality for the measles and mumps vaccine components for the adverse events for which data were available, particularly if measles or mumps vaccine-strain virus was isolated from the patient. In circumstances in which a causality assessment specific to monovalent measles or mumps vaccine was not possible, this is stated in the conclusion regarding that specific adverse event.

In circumstances in which the committee determined that a component of a multivalent preparation was causally related to a specific adverse event, but there is no direct experience of such an adverse event being caused by the multivalent preparation, the committee states this, but judges that the combined preparation also is causally related to that adverse event.

Many case reports described an adverse event(s) in a patient who received more than one vaccine. A common combination, as a result of the immunization schedules recommended in the United States, is DPT, oral polio vaccine, and Hib vaccine. Assessment of causality in those reports was more difficult than if the patient had received only one vaccine or vaccine component, but the committee considered that the reports could be theoretically supportive of causality for the combination but not in themselves sufficient to allow a firm judgment regarding causality.

CAUSALITY AND WEIGHT OF EVIDENCE

As discussed in detail in Chapter 2, the committee considered four types of evidence: biologic plausibility; case reports, case series, and uncontrolled observational studies; controlled observational studies; and controlled clinical trials. The committee used qualitative and quantitative approaches to weigh each type of evidence. Table 1-1 contains a summary of the different types of evidence for every vaccine-adverse event relation studied. The committee believes that although it is plausible that there is a causal relation between any of the vaccine-adverse event associations under review, plausibility has been demonstrated only for certain ones of these. Therefore, information on the plausibility of a causal relation was classified in Table 1-1 as either theoretical only or as demonstrated. The other types of evidence were classified in Table 1-1 as nonexistent, indeterminate, or as weighing, on the whole, for or against a determination of a causal relation. The consideration of all four types of evidence as a whole led to a conclusion of the final weight of evidence regarding causality. Table 1-2 contains these conclusions.



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