Cutter Incident

About Cutter Incident

The Cutter Incident of 1955 was one of the worst pharmaceutical disasters in US history. After the Salk polio vaccine was licensed on April 12, 1955, production was rushed to meet demand. Cutter Laboratories in Berkeley, California, failed to properly inactivate the virus in some batches. About 120,000 doses containing live poliovirus were distributed. Among vaccinated children, about 40,000 developed abortive polio, 56 developed paralytic polio, and 5 died; further spread to family and community contacts caused additional paralysis and deaths. The disaster triggered immediate suspension of the vaccination program. Regulatory oversight was strengthened. Wyeth also had production problems. The Cutter Incident led to the creation of the Division of Biologics Standards within the NIH, which later became the CBER division of the FDA. The incident established rigorous quality control requirements for vaccine production. Despite the disaster, the polio vaccination program resumed and succeeded. The incident is studied in public health ethics as a case study in the balance between speed and safety.