321 



cent effective in preventing paralytic polio in those inoculated. Then 

 he cautiously gave some indication of the calculated risk theme which 

 would later be questioned in depth by the House Committee on Inter- 

 state and Foreign Commerce. He explained that a vaccine cannot be 

 100 percent perfect : 



It is a wonderfully effective vaccine, but like most vaccines and serums we 

 have developed througli time are never perfect. We are constantly improving 

 them, and you have probably discovered that even now reports are made on work 

 that has been in progress for a number of years on types of polio vaccine, other 

 than the Salk vaccine.^^ 



When asked if PHS had rushed into licensing the vaccine and if 

 that was the cause of the current problems, Dr. Scheele answered that 

 PHS had determined to take a calculated risk, but that appropriate 

 safeguards had been taken : 



* * * Well, that, I think, would be a matter of opinion. It is one of these 

 difficult problems. A member of my staff tried to describe this thing as taking 

 all of the scientific data, and the scientists' opinions, of the known and the 

 unknown — and in science we have many unknowns — and you can spread them 

 out over a spectrum and they will run through shades of gray, but when it 

 comes then to decisions as to whether or not smallpox vaccine is ready to go or 

 typhoid vaccine was ready to go, yellow fever vaccine was ready to go, at a 

 certain point, someone interested in overall public health, an epidemiologist, 

 or someone else with similar qualifications, makes a decision as to whether the 

 factors in the imknown overweigh the factors in the known sufficiently, in rela- 

 tion to the disease one is trying to conquer to lead us to wait. 



Now, we could have waited. There were people who said that the field trials 

 should not have been done, and there were people who said that this year's 

 large-scale program should not be done. But those people were also saying in- 

 directly that another 30 or 40 thousand children should have polio. 



So what we have here, I think, both in the case of the field trial, and the 

 program on a large scale this year, we had a weighed, medical decision that 

 we should go ahead. We must remember that 5% million children — of that 

 number, 300,000 or so had Cutter, and we can cross that off as we don't know 

 the answer to whether that was the problem or not at the moment, we can 

 cross that off — had vaccine safely, with 12 cases of polio in that group. That 

 is running below our expected occurrence, that we would expect to occur 

 naturally. 



So, I would say, the balance is way in favor of the decision taken at the 

 present time, and we have safeguards, we have additional safeguards * * *.^ 



He then told how the Public Health Service had prescribed re- 

 quirements for production of the vaccine and for safety testing and 

 had then proceeded to license six manufacturers to produce the serum. 

 He explained the limitations of licensing : 



A license means that the company, the plant, is good, that there is demonstrated 

 experience in production of biological products, and that in general, there is 

 confidence in the ability of the plant to produce a suitable product * * *. A 

 license does not however clear vaccine for use.** 



Dr. Scheele then defined the responsibility of PHS, under the Bio- 

 logics Control Act, to check the product for safety, PHS, he said, did 

 not test all lots or even samples of all lots, but relied on the written 

 history of the manufacturing process : 



As the manufacturer gains experience, and as we see ourselves that his proc- 

 essing is good, we then approve lots of vaccine, after very critical review of a 

 document we call a protocol. A protocol is a series of about 30 pages of informa- 

 tion recorded by the people manufacturing the vaccine, giving every stage in 

 that process, and we are able normally in that review to detect flaws in the 



^ House. Committee on Banking and Currency. Salk vaccine hearings, op. cit., p. 10. 

 ^ Ibid., p. 58. 

 3" Ibid., p. 11. 



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