311 



the Salk vaccine. It involved such questions as whether the Federal 

 Government should assume direct responsibility for vaccinating all 

 children or only those of indigent families; ^yhether distribution 

 should be managed by the Federal Govermnent or by State or local 

 medical organizations, or by the medical profession privately; 

 whether DHEW had been sufficiently vigorous in taking appropriate 

 action when the vaccine became known, or unduly hasty in putting 

 it to work ; and whether the control over manufacture of the vaccine 

 should extend to the testing of all lots produced, or merely rely on 

 detailed descriptions (called "protocols") by the manufacturers of 

 their production steps. 



Another set of controversies centered on the basic soundness of the 

 Salk vaccine in concept. Dr. Salk's decision to develop a vaccine based 

 on the controversial use of killed rather than an attenuated live virus 

 was questioned by Albert Sabin, working on an oral attenuated vac- 

 cine, and by other virologists inside and outside of the Public Health 

 Service. These critics challenged Salk's claims about the safety and 

 efficacy of his vaccine. They "* * * thought the trials were prema- 

 ture;" there would be "* * * difficulties in killing the polio virus by 

 the Salk methods;" and there were instances reported of firms pro- 

 ducing the vaccine who had to reject unsafe lots containing live 

 virus, without knowing "* * * why some viruses were not being 

 inactivated." ^ 



Some dissatisfaction over the Salk testing program may be attrib- 

 uted to the manner in which the results of the test were announced. 

 The testing program itself had involved almost 2 million children in 

 44 States, of whom 500,000 received one or more doses of the vaccine 

 while the rest received placebos or served as observed controls. Dr. 

 Thomas Francis, Jr., head of the Poliomyelitis Vaccine Evaluation 

 Center, University of Michigan, and a renowned epidemiologist, had 

 directed the field study and the analysis of the data. However, contrary 

 to the usual medical practice of announcing scientific results in a med- 

 ical journal, for professional evaluation, the results of the Francis 

 study were disclosed at a widely publicized press conference, attended 

 by Dr. Salk, Dr. Francis, and officials of the NFIP and the Public 

 Health Service, and televised to doctors throughout the country. The 

 vaf^rine was described as successful because it had proven in this mass 

 test to be 60 to 90 percent effective in preventing polio. 



An immediate technical problem was encountered by the Public 

 Health Service in licensing the new vaccine.^ The PHS had worked 

 closely with Dr. Salk and NFIP in setting requirements for the vac- 

 cine and its commercial production. However, Dr. James Shannon, 

 Assistant Director of the National Institutes of Health, in DHEW, 

 had repeatedly recommended revision of minimum requirements to 

 assure a greater margin of safety of the vaccine. He questioned Salk's 

 belief that the virus could be adequately inactivated with formalin. 

 Nevertheless, despite the initial uncertainties over quality control, the 

 Secretary of DHEW, Mrs. Oveta Gulp Hobby, announced that PHS 

 had given its approval of the vaccine and that its manufacture had 



3 p. J. Fisher. The Polio Storv. (London, Heinemann, 1967), pp. 71-72, 

 * Section 351 of the Biologies Control Act of the PHS Organic Act instructs the PHS 

 to set requirements for the safety and efficacy of vaccines proposed for general medical use. 



