• oral polio vaccine and Guillain-Barré syndrome, and

  • unconjugated (PRP) Hib vaccine and early-onset Hib disease in children age 18 months or older who receive their first Hib immunization with unconjugated (PRP) vaccine.

The evidence establishes a causal relation between:

  • diphtheria and tetanus toxoids and anaphylaxis,h

  • measles vaccine and death from measles vaccine-strain vital infection, c,i

  • measles-mumps-rubella vaccine and thrombocytopenia and anaphylaxis,

  • oral polio vaccine and poliomyelitis and death from polio-vaccine-strain viral infection,c,i and

  • hepatitis B vaccine and anaphylaxis.

For the vast majority of vaccine-adverse event relations studied, the data came predominantly from uncontrolled studies and case reports. Most of the pathologic conditions studied are rare in the general population. The risk of developing these conditions because of vaccination would seem to be low. Without age-specific incidence rates and relative risk estimates, however, it is not possible to calculate the proportion of individuals whose condition is causally related to a vaccine. When the data permitted, such calculations (i.e., the risk difference or excess risk) were made and can be found in the conclusions in Chapters 5 through 9. Because age-specific incidence rates were not available for many of the pathologic conditions studied and because controlled epidemiologic studies of these relations are lacking, few such estimates could be made.

NEED FOR RESEARCH AND SURVEILLANCE

During its attempt to find evidence regarding causality, the committee identified needs for research and surveillance of adverse events. Work in these areas will help to ensure that all vaccines used are as free from the risk of causing adverse events as possible. Some of the needs identified are for increased surveillance of reports of demyelinating disease and arthritis following hepatitis B vaccination, better follow-up of reports of death and other serious adverse events following vaccination, increased use of large databases (currently used only on a small scale) to supplement passive surveillance reporting systems, and disease registries for the rare pathologic conditions studied by the committee.

REFERENCES

Coulter HL. Vaccination, Social Violence, and Criminality: The Medical Assault on the American Brain. Berkeley. CA: North Atlantic Books: 1990.



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