Cutter Verdict

The polio vaccination program took a body blow last spring when the disease developed in children injected with vaccine from the Cutter Laboratories of Berkeley. Calif. (TIME, May 9, et seq.). Doctors suspected that some of the vaccine must have contained live virus. Last week, after four months of investigation, the U.S. Public Health Service found fault with the Cutter vaccine and its own inadequate safety tests, since drastically revised. The PHS report:

-- An estimated 401,000 children received shots of Cutter vaccine in the fortnight before it was recalled. Polio struck 79 of the vaccinated children and 90 others who came into contact with them.

-- Cases from eleven of the 17 Cutter lots "were not higher than could be expected," but the other six lots resulted in an abnormally high number (at least 103 cases).

-- Lab studies isolated live Type 1 virus in three of the six lots. The Type i virus also showed up in the stools of 59 out of 60 polio victims, either children vaccinated from the six suspect lots, or persons who came in contact with them. Conclusion: "Infective amounts of live virus were contained in the six lots."

How did it get there? "The exact reasons," the PHS reported, "could not be found." But the PHS ruled out contamination after manufacture and testing. The only alternative: "Inadequate inactivation" of the virus, not caught because of "fundamental weaknesses" in PHS's own safety tests.*

Cutter public-relations men prepared a statement hailing the report as a complete vindication. "A weight is off my shoulders," Dr. Cutter told a friend. "I'm going home and work with my camellias.'' But U.S. Surgeon General Leonard Scheele said: "[The report] was not favorable or unfavorable ... It says there was some virus in some Cutter vaccine." Asked if PHS found Cutter production or testing was "sloppy," Scheele replied: "No evidence was found to indicate anything done by Cutter to short cut or be sloppy deliberately."

As of last week, instead of the scheduled 20 million children, only 6.5 million had been vaccinated. But the effects of the Cutter crisis were not all destructive. The PHS shook up and expanded its Laboratory of Biologies Control. Scientists, led by Dr. Jonas Salk himself, buckled down to the search for an improved vaccine. The National Foundation for-Infantile Paralysis, which rushed the vaccine program prematurely this year, grimly planned a bigger and better program for 1956.

* The virus is inactivated by mixing it with a formaldehyde solution. The key to the correct process is using just the right amount of formaldehyde and letting the brew simmer for just the right duration; too much or too long may cook the virus to a point where the vaccine is useless, while the opposite may allow live virus to remain. Under the new PHS safety procedures, manufacturers must make numerous tests on large batches of the formaldehyde-virus broth (only small samples were tested before). Now samples of every batch of vaccine are submitted to PHS laboratories (earlier, PHS examined mostly written reports).

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