1976 Swine Flu Pandemic Scare
On 27 January 1976, an outbreak of respiratory disease was identified at Ft. Dix, New Jersey. On 04 February 1976, after leaving his sick bed and making a forced, five-mile, night march, Private David Lewis, Fort Dix recruit, collapsed and died. The virus caused disease with radiologic evidence of pneumonia in at least 4 soldiers and 1 death; all of these patients had previously been healthy. On 12 February 1976 the CDC influenza laboratory notified the CDC Director that a swine influenza virus strain (H1N1) had been isolated from patients that possessed hemagglutinin and neuraminidase subtypes that had not circulated for more than 50 years - the H1(swine) N1r virus that was the putative virus of the 1918 Spanish Flu [that turned out not to be the case - the virus implicated in 1918 was probably derived from an avian species of the flu virus]. Experience had led scientists to conclude at that time that introduction of a new strain inevitably resulted in a pandemic. This new flu strain might conceivably become as big a killer as the flu of 1918, the worst ever.
One death, thirteen sick men [other accounts say that as many as 240 people fell ill, but it seems these were due to the Victoria seasonal flu virus] and up to 500 recruits who evidently had caught and resisted the disease, all in one Army camp, were the only established instances of human-to-human swine flu found around the world as February turned into March, the last month of flu season in the Northern Hemisphere. Nothing quite like Fort Dix and the lack of spread beyond it had been seen before. But an epidemic spreading into a pandemic had to be anticipated as a possibility. There was also for the first time the possibility to better the quite dismal record of 1957 and of 1968 in getting vaccine to Americans ahead of a pandemic.
On 24 March 1976 President Gerald R. Ford met with CDC, FDA, and NIH representatives and other experts. There was a unanimous recommendation to initiate mass immunization. An appropriation in precisely the amount requested was tacked onto a pending supplemental bill by an accommodating Senate Appropriations Committee. It was voted by the Senate April 9, by the House April 12, and signed into law (Public Law 94-266) on April 15, 1976, providing over $135 million for the swine flu program.
This program was an unprecedented venture in preventive medicine. It was the Government's first attempt at immunization of the entire US population. Faced with the possibility of an epidemic that could cost many lives and billions of dollars and offered a chance to prevent it, the Department of Health, Education, and Welfare (EW) planned, and the Congress approved, the $135 million swine flu program.
By June 1976 no swine flu had shown up anywhere, not even in the southern hemisphere where flu season would shortly reach its peak. All around the world there had not been a single case of swine flu for six months. The lack of cases had changed the feelings of most specialists, who sensed that odds of a pandemic were dropping week by week. Top advisers met with President Ford on 19 July 1976. Since a pandemic remained "possible," with probabilities "unknown", the vaccination program continued.
In June 1976 the lack of available liability coverage for several program participants including vaccine manufacturers and some States became threatened the successful implementation of the program. Thus ended hopes of immunizing anybody in July or even August. Nothing like that had ever occurred with immunization programs. Polio immunization had entailed far fewer numbers with sponsorship free from political taint, in a relatively unlitigious era. To resolve the liability problem, the Congress, in August 1976, enacted Public Law 94-380. Under this act, the Federal Government assumed liability for personal injuries or death resulting from the swine flu vaccine. The act provided that claims and lawsuits for injury or death resulting from the swine flu program must be filed against the Federal Government and decided through procedures of the Federal Tort Claims Act (28 U.S.C. 2671 et seq.). The new legislation became effective with the start of the new fiscal year on 01 October. Until then, manufacturers and their insurers were determined that nobody would use swine vaccine on anybody.
The first vaccine dose was given 7.5 months after the virus was identified. By 9.5 months, 150 million doses of vaccine had been produced under a federal contract. All vaccine which was released for use in the swine flu program ultimately met Food and Drug Administration potency and safety standards. Almost 30 percent of the vaccine was considered subpotent, and the agency did not permit its release to the public until the minimum potency requirement was met. Tests showed that some of the trial vaccine did not meet specified potency levels, and trial participants were not given the same protection as the general publi:. The potency test does not accurately indicate the protection provided by the vaccine.
The first vaccine was shipped to State Health Departments on 22 September 1976 and the first injections were given on 01 October 1976. HEW estimated in late March 1976 that manufacturers could produce and deliver 200 million doses of vaccine by the end of November. Primarily because of the unresolved liability questions, the first delivery was delayed -- from July to October. Vaccine available then could immunize only about 12 percent of the population. Although three of the four manufacturers said they continued to produce at full capacity during the delay and the fourth had met its original estimate, vaccine production fell short of the original estimates by about 43 million doses and required over 2 months longer to produce.
On October 11, at Pittsburgh, Pennsylvania, three persons over 70, all with cardiac conditions, dropped dead shortly after receiving swine flu shots at the same clinic. President Ford and his family got televised flu shots. On October 14, the hullabaloo subsided.
HEW officials estimated, based on past experience and trials, that the swine flu vaccine would adequately protect 70 to 90 percent of those vaccinated. Vaccination programs proceeded based on state plans and capacities, with some aggressively implementing mass vaccination and others implementing more limited programs. Overall, between October 1 and December 16, more than 40 million civilians were vaccinated. In November 1976, several cases of Guillain-Barré syndrome (GBS) - a severe neurological condition associated with paralysis that may include the respiratory muscles and may be fatal - were reported from Minnesota.
On 16 December 1976, based on CDC's recommendation and after consultation with the President, the Assistant Secretary for Health announced the suspension of the swine influenza vaccination program. The risk of developing Guillain-Barré syndrome seemed to be eleven times greater with vaccination than without. But the risk was still remote, about 1 in 105,000, and the risk of death but 1 in 2 million.
Before the swine flu program there were comparatively few vaccine-related claims made against the Government. Since 1963, Public Health Service records showed that only 27 non-swine flu claims were filed. However, as of December 31, 1979, a total of 3,839 claims and 988 lawsuits had been filed against the Government alleging injury, death, or other damage resulting from the 45 million swine flu immunizations given under the program. been filed. As of October 2, 1980, 3,965 claims and 1,384 lawsuits had been filed. Of the 3,965 claims filed, 316 claims had been settled for about $12.3 million, 2,666 claims had been denied, 151 claims had been closed, 694 claims had become lawsuits before an administrative decision was made on the claims, and 138 claims were pending action by the Justice Department. As of October 2, 1980, Federal payments for swine flu claims ($12.3 million) and lawsuits ($0.9 million) amounted to about $13.2 million.
The killer never came. The fact that it was feared is one of many things to show how little experts understand the flu, and thus how shaky are the health initiatives launched in its name. It is still not clear why the 1976 swine flu didn't spread beyond the Fort Dix base. The factors limiting its spread and duration are unknown. Nor is it known exactly how the virus was introduced. The Fort Dix outbreak may have been a zoonotic anomaly caused by introduction of an animal virus into a stressed population in close contact in crowded facilities during a cold winter. However, the impact of A/New Jersey virus on this healthy young population was severe in terms of estimated infections, hospitalizations, and duration of the outbreak.
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