Vaccine Crisis

The big blackboard seemed to loom over the auditorium at California's Department of Public Health in Berkeley. It also loomed over the nation. For the blackboard charted every case of polio that had developed after use of vaccine made by Berkeley's Cutter Laboratories; it listed the date and site of vaccination, date of symptoms' onset, location of paralysis, age and sex--but not the name--of victims. As the week went on, the impersonal box score grew. The Salk vaccine still meant to most people what it had the week before--banishment of a crippling disease. But suddenly and tragically, its safety had been put in question.

The first sign that anything was wrong came when a six-year-old San Diego youngster, Lawrence Vicker, got home for lunch from Eugene Field School and complained that he did not feel like eating. What was more, he had a stiff neck. His mother took his temperature: 103DEG. Here were three symptoms of polio (although several other diseases cause similar symptoms). Yet Larry, like 26,000 other San Diego children, had been inoculated only five days earlier with the Salk vaccine.

In the hospital, it became clear that Larry indeed had polio. There were two possibilities. Since it was, after all, the beginning of the polio season, he might have been exposed to it before he was inoculated. Or he might have caught the disease from defective vaccine.

What Went Wrong? On the day Larry Vicker was stricken, a 13-month-old boy in Pocatello, Idaho got sick too. He had been vaccinated eight days earlier. Also in Pocatello, Susan Pierce, seven, became ill with bulbar polio three days after her inoculation. Within two days she was dead. In Moscow, Idaho, another seven-year-old girl died. A rash of cases was reported, from Napa, Calif, to Chicago.

The U.S. Public Health Service made a hurried check. All reported cases of polio among vaccinated children were youngsters who had received vaccine made by the Cutter Laboratories. This raised the agonizing possibility that a batch of vaccine had gone through with some live virus in it. Like all vaccines, the Salk preparation contains germs of the disease that it is meant to fight. In the Salk process, these virus particles are killed, with formaldehyde, so that they cannot keep the power to infect (but retain the power to help the system build antibodies). Although this apparently did not happen in a single case during last year's tests, it was conceivable that somewhere along the line there had been a laboratory slip-up in the job of killing the virus.

Just what could have gone wrong? No one may be sure for weeks (or even years). But one difficulty is suspected by doctors. The formaldehyde to kill the virus must be used in just the right amount: too little leaves some deadly live virus; too much may destroy it so thoroughly that it cannot stimulate the production of antibodies. This means a narrow margin of safety. Last year's Salk vaccine, made in small pilot plants under laboratory conditions, apparently succeeded in staying within this margin. But it may develop that the margin is too slight for large-scale commercial production. If so, the Salk vaccine may have to be modified by using different strains of virus, or different ways of killing them. Both can be done.

How Good Are the Tests? Every batch of vaccine is, of course, tested for defects.* Last year each batch was subject to three rigorous tests: by the manufacturer, by the Salk laboratory, and by the National Institutes of Health's Biologies Control Laboratory. This year the full testing is being done only by the manufacturers, while the federal lab merely makes spot checks.

Every batch of Cutter vaccine has been recalled. The shipping room at the Cutter Laboratories is not shipping anything: instead, it is piled high with boxes full of bright red vaccine, being returned for testing from all over the U.S. The job will take weeks. As for the children already vaccinated, the evidence might be almost as long in coming. The incubation period--when polio virus can be multiplying in the human body without causing detectable symptoms--varies from three to 35 days. And the vaccine does not begin to be effective (that is, to develop antibodies against the multiplication of the virus) in less than seven to ten days.

What of Non-Cutter Vaccine? Weighing the evidence, the Public Health Service faced a tough decision. Paralytic cases seemed to follow the Cutter vaccine: to Idaho, Washington state and even to Denver. At the same time, there were thousands of children who had got Cutter vaccine without developing polio. But the PHS took the only course it could for safety's sake: it forbade further use of Cutter vaccine anywhere until the life-and-death question was answered. Federal virologists were painstakingly checking the Cutter Laboratories. Said Vaccine-Maker Robert Cutter: "We don't believe that they are going to find anything.''

Meanwhile, what of non-Cutter vaccine? In California, which seemed worried to the point of panic, many doctors insisted that it would take years to prove the Salk vaccine's safety, and said they would not give it to their own children. The California State Board of Public Health and a 17-man advisory committee of medical experts decreed that no Salk vaccine of any kind should be used for at least a week. That, they hoped, would give time enough to find out whether non-Cutter vaccine, at least, was safe. By week's end, only three cases of polio had occurred in children inoculated with non-Cutter vaccine (made by Eli Lilly & Co.).

In Washington, meanwhile, the nation's top polio experts met with U.S. Surgeon General Leonard A. Scheele to weigh the crisis. Among them were Dr. Salk, Dr. Thomas Francis Jr., who had tabulated last year's tests, and Dr. John Enders, Nobel Prizewinner whose discoveries had made the vaccine possible. After two days, the group told the country:

P: Cutter vaccine must stay banned, although there is no conclusive evidence that it was faulty;

P: Continued inoculation with non-Cutter vaccine is "warranted"; there is no cause to change plans. Reason: polio cases after use of non-Cutter vaccine did not develop in "significant" numbers.

At the same time, said the experts, full-force testing and investigation must continue.

* Samples of vaccine are mixed with cultures of monkey-kidney tissue. If the tissue cells go on growing normally, there is no active virus present. Also, as one of numerous further checks, vaccine is injected directly into the brains of monkeys, where any live virus would quickly cause paralysis.

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