“Operation Needle”

Abstract

The successful polio vaccine trial signaled unprecedented changes in vaccine development and use. This chapter explores the inauguration of the mass immunization of children, reveals how the lack of adequate federal regulation led to the tragic Cutter Incident, describes the emergence of additional antigen, and outlines the context for the guidelines protecting human subjects. Revelations about experiments on institutionalized children at Willowbrook State School and African Americans at Tuskegee Institute played significant roles. Using the Nuremberg Code as a basis, the Declaration of Helsinki and Belmont Report formalized enforceable guidelines for the protection of human subjects.

According to Edith Powell and John F. Hume, A Black Oasis: Tuskegee Institute’s Fight Against Infantile Paralysis , 1941–1975 (Tuskegee, AL: Tuskegee University, 2008), medical authorities in Montgomery, Alabama, designated the immunization campaign as “Operation Needle” (131).