The Cutter Incident’s 70th Anniversary: Learning from History and Application to Host Cell Proteins

The BEBPA HCP Conference will be held during the 70th anniversary of The Cutter Incident - one of the most tragic and extensive medical disasters in history. In 1955, over 120,000 people in the United States (mostly children) were injected with an inactivated polio vaccine product that had residual amounts of live polio virus. It was estimated that at least 220,000 people were infected through these injections and subsequent interpersonal contacts. Of these, 70,000 developed muscle weakness, 164 were severely paralyzed, and 10 died.(1) Despite this, few people today have heard of the Cutter Incident or know how it permanently reshaped the scientific, legal, business, and societal landscape for vaccine and biologics development. The key science-related mistakes that led to the Cutter Incident can be summarized as follows:

1. The production process was not robust: methods used for inactivation and purification of the product were not properly designed, scaled up, or monitored.
2. Analytical and bioassays were not fit to measure the safety of the final product.
3. Company managers and executives who had little-to-no scientific or medical expertise ignored warning signs.
4. Governmental regulatory authorities had little-to-no scientific expertise in virology and were pressured by internal and external entities to approve the product.

Throughout the last 15 years of my work in HCP analysis of vaccines, blood-derived products, and recombinant biologics, I have personally witnessed multiple instances of the first three mistakes listed above being made with respect to HCPs in products, especially when startup companies and CDMOs were involved. While these mistakes did not kill patients, the consequences were still serious and significant. With companies aiming for faster product development timelines in response to rapidly emerging infectious diseases, business pressures, or political pressures, a review of the steps that led to the Cutter Incident is timely.

(1) “The Cutter Incident: how America’s first polio vaccine led to the growing vaccine crisis” by Paul Offit, M.D. (2005) Yale University Press.