The Swine Influenza Immunization Program began in January 1976 with an outbreak of swine influenza among trainees at Ft. Dix, New Jersey. The program ended in December 1976 after an increased incidence of Guillain-Barre syndrome was attributed to the vaccine. The issues and events of 1976 provide valuable lessons for the future. A thorough and objective review of the swine flu program should be a prerequisite for influenza pandemic planning. Strong consideration should be given to creating separate structures for risk assessment and risk management. Risk assessment estimates the probability of a pandemic, the options available for control, and the relative benefits of those options as situations change. Risk management is the political response to that assessment.
In February of 1976, the Centers for Disease Control (CDC) investigated and confirmed that an influenza outbreak at Fort Dix had been caused by the swine-type influenza A virus. Subsequently, the Department of Health, Education and Welfare, as well as numerous medical experts, became concerned that a major flu epidemic was imminent for the coming fall. Fear of influenza deaths in numbers similar to the 1918 flu epidemic led to a recommendation that the federal government vaccinate all Americans.
When insurance companies refused to provide coverage to the vaccine manufacturers, the government agreed to accept liability for claims of adverse events (Neustadt). This obstacle having been cleared, the National Influenza Immunization Program (NIIP) officially started in October of 1976.
The number of vaccinations given each week increased rapidly from less than one million in early October to more than four million in the later weeks of the month, and reached a peak of more than six million doses a week by the middle of November 1976 (Marks). The NIIP was unique in the annals of epidemiology: an organized surveillance effort was in place from the very beginning, and over forty million people were vaccinated during the short time the NIIP was in effect.
However, on December 16, 1976 the NIIP was suspended following reports from more than ten states of Guillain-Barré syndrome (GBS) in vaccinees.
By January of 1977, more than 500 cases of GBS had been reported, with 25 deaths (Langmuir, 1979). Millions of dollars in lawsuits and many years later, we present in this paper a summary of the epidemiologic evidence of the possible causal association between influenza A/New Jersey/76 vaccine and GBS.
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Despite the lack of a definitive biological explanation for the association between the swine flu vaccine and GBS, there is strong evidence for a causal relationship. In the multiple studies performed immediately following the discontinuation of the NIIP as well as in those done almost a decade later, and using at least three distinct sources of data, there were consistent findings of increased numbers of GBS cases during the six weeks following vaccination.
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