326 



safety test in the light of the manufacturers' experience was less than satis- 

 factory. It appeared, though it was not yet establislied, that live virus might be 

 surviving even the most rigorous processing and escaping detection in the safety 

 test * * *. 



On the basis of this new information, the committee agreed that changes in 

 the minimum requirements should be considered. They felt that inactivation could 

 be more rigidly controlled and safety testing could be improved * * *. 



[Additional information] indicated that all [the] plants were having problems 

 in processing that tended to lessen confidence in the safety of commercially 

 processed vaccine in general * * *. 



[Additionally secured] data were studied, and indicated a lack of sensitivity 

 of the safety test, and this convinced the scientific advisers that even more 

 stringent criteria must lie applied both to finished lots, waiting to be assessed 

 for release, and to those still in production or to be produced * * *. 



The committee, on May 23, recommended changes in processing controls and 

 in safety tests. 



* * * Some vaccine, but not as much as we hoped, is going to be available 

 soon.^^ 



On June 10, 1955, Dr. Sclieele released the technical report com- 

 pleted by the HEAV Vaccine Advisory Committee on the Salk vaccine. 

 It was qnite candid in citinpf problems encountered in the inactivation 

 process itself, and in detailincf mistakes made by both manufacturers 

 and the PHS. First the report criticized the manufacturers for not 

 reportino; problems they had encountered in the inactivation process 

 of lots not reviewed by PHS : 



The intensive investigations of the past 5 weeks indicate that the records which 

 manufacturers were required to submit did not include certain data which are 

 essential for an adequate as.sessment of consistenc.v in performance. The protocols 

 sul)mitted related only to lots of vaccine proposed for clearance, and gave no 

 information concerning lots discarded in the course of manufacture. Further, 

 the information requested did not bring out certain data on processing and testing 

 now known to be important. 



The total experience of the manufacturers now reveals that the process of 

 inactivation did not always follow the predicted course, since positive tissue 

 culture tests not infrequently occurred after the expected completion of the 

 inactivation process. Greater dependence, therefore, must be placed on sensitive 

 tests for very small quantities of residual live virus as part of process control 

 than would otherwise l)e the case.^" 



By implication, Scheele's report also criticized the NFIP for its 

 haste in rushino- to develop and manufacture the vaccine before the 

 accumulation of adequate scientific knowledge: 



The vaccine has progressed from the experimental level to large-scale pro- 

 duction with unprecedented rapidity * * *, 



Events have been telescoped in time that the vaccine has been developed, 

 tested, and used in a matter of months instead of years. Procedures which 

 appeared sound and adequate several months ago on the basis of experience 

 up to that time, have had to be modified in the light of scientific and technical 

 data now available."" 



Included in the report were PHS's new official mandatory regula- 

 tions for safety testing and processing. Among them were: "Required 

 uniformity of sampling," "application of more tests at two critical 

 points in the manufacturing process," necessity for the manufacturer 

 to "test a random sample of vaccine from the final containers of each 



"^sibld., pp. 47-50. 



^"U.S. Department of Henlth, Education, and Welfare. Public Health Service. Technical 

 Report on Salk Poliomyelitis Vaccine. June 195.5 ([Washington], Department of Health, 

 Education, and Welfare. June 1955. mimeo), p. 3. 



60 Ibid., pp. 4, 88. 



