Adverse Events Associated with Childhood Vaccines: Evidence Bearing on Causality

281 Recommended for incoming undergraduate students, the book provides a quick understanding of the important terms and techniques for current DNA-related research. Its utility for medical students, however, is somewhat limited by its brevity and enormous scope. At almost $40 in hardcover, the book is far too expensive. At $16.95 in softcover, it remains somewhat less so, but may be worth the cost for a rapid introduction to genetic engineering. review of evidence from the scientific literature and from adverse event surveillance systems , concerning causal relationships, or lack thereof, between each adverse experience (AE) and the vaccine that preceded it. It supplements a companion volume (Adverse Effects of Pertussis and Rubella Vaccines) and addresses AE issues related to diphtheria and tetanus (T) toxoids (or DT for children and Td for adults if combined), measles, mumps, polio (OPV and IPV), hepatitis B and Hemophilus influenzae type b vaccines. Evidence on causality of AEs is categorized into five classes, including: no evidence, inadequate evidence, evidence favoring rejection, evidence favoring acceptance or evidence establishing a causal relationship with the given vaccine. Special analyses are included of the evidentiary basis for causality, of the varieties of neurologic and immuno-logic reactions and of post-vaccination death. The last chapter reviews areas most needing additional research and enhanced surveillance. Most of the serious AEs reviewed are rare, a fact that poses some difficulty in assessing causality, since rare serious AEs are typically far less often reported after vaccination compared to the population at large. Additional difficulty arises from the paucity of controlled trial data, a deficiency often impossible to remedy, given the huge populations needed to ensure detection of such rare events. The majority of the data, based on case reports and uncontrolled observational studies, is therefore appropriately graded as indeterminate by the committee. The rarity of the most serious AEs, especially compared to adverse outcomes caused by the respective diseases prevented by vaccination, points to the immense societal benefit in relation to the rare risk of serious harm associated with mass vaccination with these vaccines. Key findings include evidence favoring rejection of causal linkage between encephalopathy, sudden infant death syndrome (SIDS) or infantile spasms and DT or Td (or T separately) and between early onset H. influenzae b disease and related conjugate vaccines. Evidence was judged to favor acceptance of causality between DT, Td or T and brachial neuritis or Guillain-Barre syndrome, between measles vaccine …