Making history: Thomas Francis, Jr, MD, and the 1954 Salk Poliomyelitis Vaccine Field Trial.

Abstract

This article focuses on the poliomyelitis vaccine field trial directed by Thomas Francis,Jr, MD, of the University of Michigan Vaccine Evaluation Center and sponsored by the National Foundation for Infantile Paralysis (NFIP) or, as it was better known to the public, the March of Dimes. It was a landmark in the widescale testing of a vaccine and the ethical use of human subjects. Millions of American parents readily volunteered their healthy children to participate. A total of 150,000 volunteers, including schoolteachers, physicians, nurses, and health officers all endorsed the study and donated their time and effort to make it successful. Avoiding the use of marginalized groups, the field trial purposefully did not involve institutionalized children; instead, it was based in 15,000 public schools in 44 of the 48 states as clinic sites. A group of 650,000 children received some type of injection, either the vaccine or a placebo, and another 1.18 million served as controls. The field trial depended, most essentially, on both public support and the participation of millions of children who remained enrolled in a study that required a series of 3 injections and a 6-month evaluation period. Enlisting the huge number of participants presented practical examples of the difficulties in experimenting on human subjects. On April 26, 1954, Randy Kerr, a participant or "Polio Pioneer" as the children involved were called, received the first inoculation of the Salk poliomyelitis vaccine. The nationwide study "designed to test the safety and efficacy" of the Salk vaccine had officially begun.