Kr. Stratton et al., ADVERSE EVENTS ASSOCIATED WITH CHILDHOOD VACCINES OTHER THAN PERTUSSIS AND RUBELLA - SUMMARY OF A REPORT FROM THE INSTITUTE-OF-MEDICINE, JAMA, the journal of the American Medical Association, 271(20), 1994, pp. 1602-1605
In September 1993, the Institute of Medicine released a report entitle
d Adverse Events Associated With Childhood Vaccines: Evidence Bearing
on Causality. The report examined putative serious adverse consequence
s associated with administration of diphtheria and tetanus toxoids; me
asles, mumps, and measles-mumps-rubella vaccines; oral polio vaccine a
nd inactivated polio vaccine; hepatitis B vaccines; and Haemophilus in
fluenzae type b (Hib) vaccines. The committee spent 18 months reviewin
g all available scientific and medical data, from individual case repo
rts (published and unpublished) to controlled clinical trials. The com
mittee found that the evidence favored the rejection of a causal relat
ion between diphtheria and tetanus toxoids and encephalopathy, infanti
le spasms, and sudden infant death syndrome, and between conjugate Hib
vaccines and susceptibility to Hib disease. The committee found that
the evidence favored acceptance of a causal relation between diphtheri
a and tetanus toxoids and Guillain-Barre syndrome and brachial neuriti
s, between measles vaccine and anaphylaxis, between oral polio vaccine
and Guillain-Barre syndrome, and between unconjugated Hib vaccine and
susceptibility to Hib disease. The committee found that the evidence
established causality between diphtheria and tetanus toxoids and anaph
ylaxis, between measles vaccine and death from measles vaccine-strain
viral infection, between measles-mumps-rubella vaccine and thrombocyto
penia and anaphylaxis, between oral polio vaccine and poliomyelitis an
d death from polio vaccine-strain viral infection, and between hepatit
is B vaccine and anaphylaxis. For five vaccine-related adverse events,
there was no evidence identified. For the remaining 33 vaccine-relate
d adverse events, the evidence was inadequate to accept or reject a ca
usal relation.