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Guillain-Barré Syndrome

What NIIP did not and could not survive, however, was the second blow, finding cases of Guillain-Barré syndrome (GBS) among persons receiving swine flu immunizations. As of 1976, >50 “antecedent events” had been identified in temporal relationship to GBS, events that were considered as possible factors in its cause. The list included viral infections, injections, and “being struck by lightning.” Whether or not any of the antecedents had a causal relationship to GBS was, and remains, unclear. When cases of GBS were identified among recipients of the swine flu vaccines, they were, of course, well covered by the press. Because GBS cases are always present in the population, the necessary public health questions concerning the cases among vaccine recipients were “Is the number of cases of GBS among vaccine recipients higher than would be expected? And if so, are the increased cases the result of increased surveillance or a true increase?” Leading epidemiologists debated these points, but the consensus, based on the intensified surveillance for GBS (and other conditions) in recipients of the vaccines, was that the number of cases of GBS appeared to be an excess.

Had H1N1 influenza been transmitted at that time, the small apparent risk of GBS from immunization would have been eclipsed by the obvious immediate benefit of vaccine-induced protection against swine flu. However, in December 1976, with >40 million persons immunized and no evidence of H1N1 transmission, federal health officials decided that the possibility of an association of GBS with the vaccine, however small, necessitated stopping immunization, at least until the issue could be explored. A moratorium on the use of the influenza vaccines was announced on December 16; it effectively ended NIIP of 1976. Four days later the New York Times published an op-ed article that began by asserting, “Misunderstandings and misconceptions … have marked Government … during the last eight years,” attributing NIIP and its consequences to “political expediency” and “the self interest of government health bureaucracy” (Schwartz, 1976). These simple and sinister innuendos had traction, as did 2 epithets used in the article to describe the program, “debacle” in the text and “Swine Flu Fiasco” in the title.

On February 7, the new secretary of DHEW, Joseph A. Califano, announced the resumption of immunization of high-risk populations with monovalent A/Victoria vaccine that had been prepared as part of the federal contracts, and he dismissed the director of CDC.

Lessons Learned

NIIP may offer lessons for today’s policymakers, who are faced with a potential pandemic of avian influenza and struggling with decisions about preventing it (Box A11-1). Two of these lessons bear further scrutiny here.



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