Monday, May. 23, 1955
Vaccine Evidence
All week long, the casualty list among children inoculated with Salk vaccine kept going up, but fortunately the rate of climb was slowed. The U.S. Public Health Service got moving on its promised "re appraisal" of all vaccine so far finished by the manufacturers. By week's end the reappraisal teams were authorizing renewed release of vaccine, and inoculations could resume this week.
Clean Bill. First manufacturer to get a going-over was Detroit's Parke, Davis & Co. -- largely, no doubt, because its vac cine so far had a spotless record and there was every reason to believe that the PHS would have good news about it. The in vestigating team did not repeat the whole testing procedure, which takes three months. Instead, it quizzed the technicians in the testing rooms. Team members not only again pored over the bulky "pro tocols" (elaborate reports from manufac turer to Washington, showing the result of every phase of every test); they also leafed through the underlying data.
After two days' inspection, the reap-praisers okayed the Parke, Davis vaccine.
Most of it has been shipped and used al ready, but on hand was enough vaccine for about a million shots. An additional batch of 350,000 cc., ready for shipping, was held back to give the PHS time to reappraise its own reappraisal.
With Parke, Davis in the clear, teams headed for the other labs. Still under ban were the. Cutter Laboratories in Berkeley, Calif. No positive proof could yet be drawn from the raw data on Cutter, but a top epidemiologist called them, in his professional patter, "clear evidence that [outbreaks in California and Idaho] have all the characteristics of a common-source epidemic, the Cutter vaccine being the vehicle of infection."
Damning Incidence. At week's end, Surgeon General Scheele told the House Banking & Currency Committee that there had been 67 cases of polio among vaccinated children: 55 after Cutter vaccine, ten after vaccine from Eli Lilly & Co., two after Wyeth Laboratories vaccine.
The damning fact was what the experts call incidence. Among the 294,000 children who received Cutter vaccine, at the time of year and in the regions concerned, polio cases would be expected by chance at the rate of one a week. But there had been five cases in the week ended April 23, and no fewer than 30 in the next week. Among the 5,200,000 who got vaccine frorrTbther labs, the reverse was true : there were actually fewer polio cases than would have been expected by chance. Ruminating on what could have gone wrong in vaccine mass production (see below), one expert said: "It seems clear that polio vaccine which, by all tests, shows no live virus is still able to infect some people."
Apart from Cutter's, is the vaccine newly cleared by the Government safe?
Said Surgeon General Scheele: "I wish to reaffirm my faith in the vaccine." But the doubts raised by-the Cutter trouble could not be undone. This week, more over, with Secretary Oveta Gulp Hobby finally submitting her long-promised recommendations on "voluntary controls" to the President, the confused issue of distribution would once more be added to the problem of safety. All things considered, more and more experts now agreed with last year's skeptics that, instead of rushing into mass production and distribution of the vaccine, it would have been better to give over 1955 to further tests and careful preparation.
This file is automatically generated by a robot program, so reader's discretion is required.