Revisiting the possibility of serious adverse events from the whole cell pertussis vaccine: Were metabolically vulnerable children at risk?

SummaryIn the early 1980’s concerns about the safety of the whole cell pertussis vaccine in the United States resulted in declining vaccination rates and the withdrawal of multiple vaccine providers from the market. While the possibility of inflammation and febrile reactions to the vaccine were acknowledged by public health authorities, parents also claimed the vaccine was associated with sudden infant death syndrome and encephalopathy. Epidemiological studies examining this question, however, consistently failed to identify an association. We argue that these reactions may have occurred in metabolically vulnerable children, specifically those with defects in fatty acid oxidation. In these children the combination of anorexia and fever that could be caused by the vaccine may have resulted in hypoglycemic episodes and possibly death. We believe that this association was not detected because these conditions were not recognized at the time and because these conditions are uncommon. Nevertheless, at a population level, enough events could have occurred to cause concern amongst parents.