The 1954 Salk poliomyelitis vaccine field trial

On April 12, 1955, Thomas Francis, Jr., Professor of Epidemiology at the University of Michigan, held a press conference in Ann Arbor to announce the results of a ‘field trial’ of an experimental poliomyelitis vaccine. ‘Some of the best educated persons in American journalism’ elbowed each other aside to get their hands on a copy of the press release. The journalists’ ardor was not surprising: more Americans knew about the vaccine trial ‘than knew the full name of the President of the United States’ [1]. The ‘biggest public health experiment ever’ had enrolled 1,022,684 school children in 44 states. 300,000 school teachers, ‘classroom mothers’ and ‘clubwomen,’ nurses, physical therapists, doctors, and public health officials had volunteered to organize the immunizations and track polio cases [2,3]. Around the country, vaccine supplies were stockpiled, as families, physicians, and government officials waited to hear whether the new vaccine had worked. Francis’ announcement that the vaccine was ‘80 to 90 per cent effective against paralytic poliomyelitis’ did not satisfy Jonas Salk, the vaccine’s inventor, who promised future results of ‘100 per cent’ effectiveness [1,4]. No medical study, before or since, approaches the 1954 Salk vaccine field trial in size, complexity, or the extent of public involvement. The trial was initiated not by the federal government but by a private organization, the National Foundation for Infantile Paralysis (NFIP), which raised its money from millions of small donations. Ordinary citizens paid for the study, recruited the children who took the vaccine and the volunteers who helped administer it. It is a small wonder that trialists and vaccine researchers look back admiringly, even longingly, at the study [5–8]. Yet, the most remarkable fact about the 1954 field trial may not be the massive organizational effort involved, or the rigorous methodological design ultimately imposed. Given repeated controversies about the vaccine’s safety and the field trial’s design, it is remarkable that the trial was ever begun, much less successfully completed. The sciences of vaccine testing and of clinical trials are complex. Add parents, physicians, school, and health officials from 3100þ communities and the process grows even messier, little resembling the orderly procedure the textbooks prescribe. In Pittsburgh, Jonas Salk continued modifying the test vaccine until a few months before the study was launched. The field trial itself was shaped by decisions taken not only in New York at the NFIP’s headquarters, or in Francis’ Ann Arbor, but also in places like Montgomery, Alabama, where local health and school officials decided to go ahead with the trial, and Arlington, Virginia, where the community decided against participation. In this article I will try to capture the difficulties trial organizers faced, the contingencies they encountered along the way and the actions taken to overcome these obstacles.