U.S. Tightens Standard Of Polio Vaccine

Press, Volume XCI, Issue 27669, 27 May 1955, Page 13

U.S. Tightens Standard Of Polio Vaccine

(Rec. 9 p.m.) WASHINGTON; May 25 The United States Government tightened its safety standards for the Salk poliomyelitis vaccine today and set up a special committee of scientists to advise on each batch of the vaccine before it is cleared for use. The Surgeon-General (Dr. Leonard Scheele) said the erpation of the clearance committee was the first step towards a resumption of the mass vaccination programme. The Government should be able to say soon when inoculations could get under way again, he added. The Federal Health Service said the committee would hold its first meeting tomorrow. Its members include Dr. Jonas Salk, who developed the vaccine, and Dr. Thomas Francis, who prepared the original report on its effectiveness. The committee will use the revised safety standards in its new study of the safety reports submitted by the vaccine manufacturers. Mr E. N. Beesley, president of the

Eli Lilly Company, one of the largest vaccine manufacturers, said he expected the standards to be realistic and practical. Some manufacturers earlier had feared the Government might go to what they described as “unrealistic” extremes to establish the safety of the vaccine.

The committee will review all the vaccine already produced but not yet released for inoculations, and all vaccine produced in the future. Dr. Scheele will make the final decision on clearance.

Dr. Scheele said the Government had confirmed the safety of all the Salk vaccine produced by drug companies, except possibly two lots made by the Cutter Laboratories of Berkeley, California.

He said: “There is strong presumptive evidence that there i 3 a cause and effect relationship between certain of paralytic poliomyelitis and the use of two lots of Cutter vaccine out of the nine released.”

But he did not say that such a relationship had been proved to exist. “It appears that the incidence of cases associated with the Cutter vaccine is probably over, although there may be a few widely-scattered cases whiqh have not yet been reported.”

The Cutter vaccine was withdrawn from use on April 27. The Public Health Service, in its latest report, says that 60 persons who received the Cutter vaccine subsequently developed poliomyelitis. Another 32 children who

contracted the disease after inoculation had received vaccine from three other companies. All but 19 of the 92 children have paralytic poliomyelitis. Dr. Salk did not attend the session of scientists yesterday to discuss the problems. Questioned today by reporters, he would not say why he was absent, but he added: “Dr. Scheele knows.” He said the reason was not, as had been previously reported, that he had other commitments.

When Dr. Scheele was asked about the scientist’s absence, he said: “Ask Dr. Salk. I am not the person to say why he was not there.” Detectives yesterday traced 1260 shots of Salk vaccine which were earlier reported to have disappeared from New Haven. The vaccine was discovered at Meriden, Connecticut It apparently had been delivered there in error.