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Saving Vaccines: A Look at How Current Liability Laws Are Keeping Much-Needed Vaccines Off the Market

By Paul A. Offit, M.D.
February 28, 2006

On April 12, 1955, Thomas Francis stood on a podium at the University of Michigan and announced that Jonas Salk's polio vaccine was safe and effective. At last, Americans would be freed from the bonds of polio, a disease that routinely crippled as many as 50,000 children every year. However, triumph quickly turned to tragedy.

On April 28, 1955, 2 weeks after millions of doses of Salk's formaldehyde-inactivated polio vaccine had been sold to the public, several children developed paralysis. All of the paralyzed children lived in the West and Southwest; all first developed paralysis in the arm that was injected and, although five companies made polio vaccine in 1955, all had received vaccine made by one company ' Cutter Laboratories of Berkeley, CA.

The federal agency responsible for licensing vaccines in 1955, the Laboratory of Biologics Control, asked Cutter to recall all of its vaccine. Unfortunately, it was too late; 120,000 children had already been injected with a vaccine that inadvertently contained live, dangerous polio virus. As a consequence, 40,000 children developed mild polio; 200 were permanently paralyzed, and 10 were killed. It was one of the worst pharmaceutical disasters in U.S. history.

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