The cutter vaccine incident
The mistake produced 120,000 doses of polio vaccine that contained live polio virus. Of children who received the vaccine, 40,000 developed abortive poliomyelitis (a form of the disease that does not involve the central nervous system), 56 developed paralytic poliomyelitis—and of these, five children died from polio.[2] The exposures led to an epidemic of polio in the families and communities of the affected children, resulting in a further 113 people paralyzed and 5 deaths.[3]
Surgeon General Scheele sent Drs. William Tripp and Karl Habel from the NIH to inspect Cutter's Berkeley facilities, question workers, and examine records. After a thorough investigation, they found nothing wrong with Cutter's production methods.
The Cutter incident was one of the worst pharmaceutical disasters in US history, and exposed several thousand children to live polio virus on vaccination.[3] The NIH Laboratory of Biologics Control, which had certified the Cutter polio vaccine, had received advance warnings of problems: in 1954, staff member Dr. Bernice Eddy had reported to her superiors that some inoculated monkeys had become paralyzed (pictures were sent as well). William Sebrell, the director of NIH wouldn't hear of such a thing.[4]