313 



emergency protection for want of ability to pay for it." ® It was then 

 reported that the President would submit legislation recommending a 

 voluntary State progi*am partially financed by Federal funds for 

 indigent children. 



Early difficulties with quantity production 



Apparently unknown to the reporters questioning the President on 

 April 27, it was announced that same day that the Surgeon General 

 had requested the Cutter Laboratories to withdraw its vaccine lots from 

 tlie NFIP inoculation program. The Surgeon General reported that 

 some children inoculated with vaccine from the Cutter lots were getting 

 polio — in the limb where the injection was made. Other reports stated 

 that some inoculated children were transmitting the disease to those 

 not inoculated and to susceptible parents. 



On April 30, 18 days after the announcement of the success of the 

 vaccine, the Surgeon General advised manufacturers that approval of 

 new lots of vaccine had to await pending revision of PHS minimum 

 safety and production standards. And on May 8, the vaccination pro- 

 gram was wholly suspended while the manufacturing processes of all 

 the licensed pharmaceutical firms were reappraised by PHS. On 

 May 27, the PHS promulgated revised manufacturing standards and 

 safety test regulations. Small amounts of vaccine again began to be 

 released to the NFIP; however, the Cutter contractural arrangements 

 were canceled. Finally on June 10, the PHS attributed the problem to 

 faulty manufacturing processes : Clumps of live virus in the vaccine 

 were not being inactivated by the formalin. 



The distribution issue in congressional hearings 



The administration's distribution plan was introduced on May 16, 

 1955, by Senator H. Alexander Smith, Republican of New Jersey, 

 (S. 1984). It proposed a voluntarv system at the State level aided 

 by $28 million in grants to the States to vaccinate only children 

 in low-income groups. Democratic Members of Congress presented 

 several alternatives for tighter Federal control of distribution, includ- 

 ing: (a) free vaccination of all children of critical age groups regard- 

 less of need ; (b) a Federal program to buy and directly distribute the 

 vaccine to all regardless of means (S. 1781, S. 2147, H.R. 5599, H.R. 

 5611, H.R. 5696, H.R. 5983, and H.R. 5987) ; (c) standby or permanent 

 mandatorv Federal controls and regulations for the distribution and 

 use of vaccines (S.J. Res. 68, S. 1925, S. 1691, H.J. Res. 297, H.J. Res. 

 298. H.J. Res. 299, H.J. Res. 300, and H.J. Res. 302). 



The initial concern of the congressional committees looking at the 

 issue of polio vaccine was to evaluate the legislative alternatives for 

 distribution. The questions of safety and efficacy were also cautiously 

 explored. Legislators questioned whether the committees concerned 

 with distribution possessed the capability or jurisdictional prerogative 

 to investigate polio research and PHS safety testing and licensing pro- 

 cedures. Yet they realized that the technical issue was intimately re- 

 lated to the legislative alternatives for distribution. Congress sought 

 assurance that it would not be financing distribution of a hazardous 

 biological. It received this assurance and proceeded to arrange for 

 assistance in a national program of distribution. As to the technical 

 problems in PHS, no legislative action was found necessary. 



s President Dwlght David Eisenhower. The President's news conference of May 4, 1955. 

 In ibid., p. 460. 



