1955 – Polio Vaccine (Cutter Labs, USA)

On April 12, 1955, Cutter Laboratories was one of several companies that the United States government licensed to produce the Salk polio vaccine. In what became known as the “Cutter Incident,” some lots of the Cutter vaccine (despite passing required safety tests) contained live polio virus in what was supposed to be an inactivated-virus vaccine. 

Cutter withdrew its vaccine from the market on April 27th after vaccine-associated cases of polio were reported. This tragedy resulted in 10 deaths and 51 children being paralyzed.

Several possible reasons for this incident were pinpointed, including:

• Inconsistent viral inactivation process
• Quick scale-up of production without proper validation of the inactivation steps – essentially that Cutter Labs was trying to meet market demands without adequate Quality Control in place.
• A scale-up of heat inactivation step which may not have been enough

What GMP Lessons Can We Learn From This?

One of the obvious solutions would have been the introduction of a robust process validation coupled with batch by batch quality control (QC) Testing and batch release system.

If you are not familiar with process validation, it is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.