Government halts vaccine approval pending safety review

WASHINGTON, May 6, 1955 (UP) - Dr. Leonard A. Scheele, U.S. surgeon general, said today the Government has stopped approving the newly manufactured Salk polio vaccine pending review of safety standards. Scheele told congressmen that does not mean that the actual manufacture of the vaccine has been halted.

He testified that the Government has not approved any new vaccine production for the past several days. He said approval has been "brought to a standstill until we can evaluate standards and safety."


Scheele spoke as Dr. Jonas A. Salk and other top polio scientists held a secret meeting on future production and use of the vaccine.

Scheele told a House committee today that the shots should go on.

He confirmed that 44 children inoculated with the Salk vaccine have developed polio. At least 36 of them had received Cutter Laboratory vaccine.

But Scheele pointed out that between 4,000,000 and 6,000,000 had been vaccinated and that he felt there was not necessarily any cause and effect in the 44 cases.

Scheele said he felt confident that the scientists, who are meeting at nearby Bethesda, Md., will announce that the program should be continued.

Scheele also told the committee that the Government is considering a plan to have U.S. Public Health Service experts test every batch of vaccine before it is cleared for use.


This was done during the Salk tests last spring but has not been followed this year. Only samples from the various drug firms have teen tested in federal laboratories.

The companies, of course, are running their own tests on all vaccine.

Technically, the scientists meeting at Bethesda are deciding whether new tests and production controls are necessary to insure the safety of the vaccine.

But pending their decisions:

The output of vaccine is grinding to a halt, with major producing companies refusing to complete the final processing steps on stocks of vaccine in their plants.

The government's voluntary plan for allocating and distributing the vaccine is being held up. Originally scheduled to be submitted to President Eisenhower today, it will be delayed at least until next the week.

Despite the veil of secrecy, informed sources confirmed the serious and far-reaching nature of the deliberations.

They attributed this to:

Mounting concern that the number of children who have contracted polio after receiving vaccine produced by the Cutter Laboratories, Berkeley, Calif., may be more than coincidence.

A California health department spokesman admitted today a considerable amount of the Cutter vaccine still is on the market despite urgent efforts to call it all back.


Reluctance of some states - including New York and Massachusetts - to go ahead with vaccinations and severe criticism of the programs by some medical groups - including the California State Medical Society - which are urging the scientists to exercise great caution.

The virtual halt in the output of vaccine - suspected for several days and confirmed in part Wednesday by the Public Health Service -- was revealed today by a spokesman for Ell Lilly & Co. of Indianapolis, the largest producer.

The spokesman said that, pending final decisions by the scientists meeting in Washington, Eli Lilly was not putting the finishing touches on a "considerable" stock of vaccine now piling up in its laboratory.

The other four drug firms turning out vaccine presumably are following the same course.

The Lilly spokesman explained that if the scientists proposed new tests or additional processing, all vaccine on which final production steps were completed would be lost.

For that reason, he said, the company is not adding preservative and packaging vaccine which otherwise would be ready for distribution.

This will make it possible to run further tests on the unfinished vaccine or make changes in it if the scientists so recommend.


The spokesman added that final "clearance" of some batches of Lilly vaccine also is being held up by the Public Health Service in Washington -- presumably also pending the outcome of the meeting.

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