The Cutter Incident
In April 1955 more than 200,000 children in five Western and mid-Western states received a polio vaccine in which the process of inactivating the live virus proved to be defective. Within days there were reports of paralysis and within a month the first mass vaccination program against polio had to be abandoned. Subsequent investigations revealed that the vaccine, manufactured by the California-based family firm of Cutter Laboratories, had caused 40 000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10.
The Cutter incident led to the effective federal regulation of vaccines, which today enjoy a record of safety `unmatched by any other medical product'. On the other hand, the court ruling that Cutter was liable to pay compensation to those damaged by its polio vaccine—even though it was not found to be negligent in its production—opened the floodgates to a wave of litigation.
In the immediate aftermath of the Cutter incident Salk's inactivated virus was replaced by Sabin's attenuated live-virus, even though the risk of the attenuated virus reactivating and infecting patients was a risk.
References:
Centers for Disease Control and Prevention. Historical Vaccine Safety Concerns: Cutter Incident, 1955. https://www.cdc.gov/vaccinesafety/concerns/concerns-history.html
Fitzpatrick M. (2006). The Cutter Incident: How America's First Polio Vaccine Led to a Growing Vaccine Crisis. Journal of the Royal Society of Medicine, 99(3), 156.
