1955

Congress passes Poliomyelitis Vaccination and Assistance Acts following federal approval of Salk vaccine (Sealander, 337-339) following unanimous approval of committee of Laboratory of Biologics Control on 12 April after only 2.5 hours of discussion (it now requires one year to get new vaccine approval). The Laboratory never saw information. Bernice Eddy, responsible for polio vaccine, had given to William Ward that three of the six samples of vaccine submitted by Cutter Laboratory to the laboratory months earlier contained live polio virus. Within nine days of receiving Cutter Lab injections of vaccine, between April 25-37, 1955, six children in Chicago and CA. developed paralysis, initially at site of Cutter injection (Offit, loc 720ff.). By 30 April, within 48 hours of Surgeon General’s recall of all Cutter vaccines, the vaccine had killed or paralyzed 25 children (loc 891). In all, two lots of Cutter vaccine, contained live virus of the most virulent Mahoney strain, paralyzed 51 and killed 5 children; plus, extrapolating from 1957 study of Idaho school children, one of three children (at least 40k) contracted abortive polio. Since abortive polio develops in about one of three children infected with natural polio, “it is likely that all 120,000 children were injected with live virulent polio virus” (loc 984). In all 9 of Cutter’s 27 lots failed to pass safety tests. Actually, all five labs licensed to produce Salk vaccine were having trouble producing lots with 100% killed vaccines with formaldehyde within the 14 days stipulated in the protocol. One, Wyeth, brought to market a single bad lot that caused paralysis, but it was hushed up and never released to media, lest the public lose confidence in the entire program. Better to pin it all on Cutter, the smallest and least well known of the manufacturers. Seven events at Cutter that resulted in its contaminated polio vaccine: (1) It used the deadly Mahoney strain (like the other four companies); It used the troublesome glass filtration method rather than the reliable Seitz filters; (3) safety tests were inadequate: “Of all the companies, Cutter used the least amount of vaccine to test for safety – one-tenth as much as Lilly”; (4)Cutter, alone among the five companies, let filtered virus sit in refrigerator for long periods before inactivating it with formaldehyde; (5) Cutter, alone among the five companies, never constructed a graph to determine how long to treat polio virus with formaldehyde; (6) Cutter never told other polio researchers it was having problems; (7) fed. govt didn’t know Cutter was having a problems. The fed. govt dropped consistency requirement of 11 consecutive lots of vaccine that passed safety tests than the Natl. Foundation had imposed on Lilly and Parke-Davis during the field trial of 1954 (Offit, chap. 6).