The 1976 Swine Flu Vaccine Debacle – A Cautionary Tale for 2020

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By Peter Chow

In January 1976 several soldiers at Fort Dix, New Jersey, complained of a respiratory illness diagnosed as influenza.

18 year old Private David Lewis, had flu symptoms, and despite being cleared to remain in quarters for 48 hours, loaded his 50 lb. pack and joined his platoon for an all-night 5 mile forced march in the bitter New Jersey winter.

After a few hours he collapsed. He died just hours after reaching the base hospital.

It would never be known for certain whether he died because he was infected with a particularly lethal, virulent strain of influenza, or if he died because he went on an overnight winter full-pack forced march while in peak viremia with a modestly dangerous influenza strain.

It is exceedingly rare for a healthy teenager to die of influenza. However, a hallmark of the great 1918 influenza pandemic was the virus’s spectacular ability to kill young adults.

The New Jersey Department of Health tested samples from the Fort Dix soldiers. The majority of samples were of the more common A/Victoria/75 flu strain, an influenza A/H3N2, which was the prevalent flu strain in the world in the January 1976.

But two were not, including the samples from Private Lewis. The atypical samples were sent to the Centers for Disease Control in Atlanta, Georgia, which found evidence of H1N1 Swine influenza A, dubbed influenza A/New Jersey/H1N1 and antigenically closely related to the 1918 flu pandemic which had killed 50 million people worldwide.

Panic ensued.

Eventually 155 cases of H1N1 flu were found at Fort Dix. The entire U.S. health care establishment waited with bated breath for signs of further mass spread.

The consequences of denying the possibility that Private Lewis’s death was a harbinger of an epidemic akin to that of 1918-1919, and then having such a devastating event catch the country unprepared, was simply too dreadful. The CDC was rightfully overwhelmed by the fear of having hundreds of thousands of deaths attributed to health officials who had chosen to take a wait-and-see approach.

The Center for Disease Control verified the findings and informed the World Health Organization. On February 13, the CDC sent out a memo detailing the evidence for a Swine Flu outbreak and calling for mass immunization, requesting $135 million for development and distribution of a vaccine.

President Gerald Ford was officially informed of the outbreak and the suggested immunization program on March 15. He met with a “blue ribbon” panel which included polio vaccine inventors Jonas Salk and Albert Sabin. Ford then made a televised announcement in support of the mass immunization program.

Congress had no choice but to support the President. A bill approving $135 million for the Swine Flu immunization program was passed on April 5.

As he signed the bill, Ford dropped all pretense of doubt or conjecture, saying that the Fort Dix virus “was the cause of a pandemic in 1918 and 1919 that resulted in over half a million deaths in the United States.”

For several months, the four drug firms that developed the vaccine — Merck’s Sharp & Dohme, Merrell, Wyeth, and Parke-Davis — refused to sell to the government the vaccine they had manufactured until they got full liability indemnity and a guaranteed profit.

Congress ended up passing a bill that guaranteed their profits and officially waived corporate liability for Swine Flu vaccines.

Merck made the first shipment of vaccines to state health departments by September 22. The first swine flu inoculations were given at the Indiana State Fair.

The President and his family received their immunizations before the television cameras.

Then, in late November, cases of Guillain-Barré syndrome affecting vaccinated patients were reported in several states.

Guillain–Barré syndrome (GBS) is a rare, usually reversible, occasionally lethal, rapid-onset muscle weakness caused by the immune system damaging the peripheral nervous system. The initial symptoms are typically changes in sensation or pain along with muscle weakness, beginning in the feet and hands, often spreading to the arms and upper body, with both sides being involved. The symptoms may develop over hours to a few weeks. During the acute phase, the disorder can be life-threatening, with about 15 percent of people developing weakness of the breathing muscles and, therefore, requiring mechanical ventilation. Some are affected by changes in the function of the autonomic nervous system, which can lead to dangerous abnormalities in heart rate and blood pressure.

The underlying cause involves an autoimmune disorder in which the body’s immune system mistakenly attacks the peripheral nerves and damages their myelin insulation. Sometimes this immune dysfunction is triggered by an infection and rarely by vaccination.

More cases of Guillain-Barré were reported in early December and the investigation into cases of it spread to eleven states. On December 16, a suspension of the vaccination program was announced by the CDC. The CDC estimated that the incidence of Guillain-Barré was four times higher in vaccinated people than in those not receiving the swine flu vaccine.

Of the 45 million people vaccinated against the 1976 swine flu, 450 people developed Guillain-Barré syndrome, a prevalence of 1 in 100,000.

The vaccination program was over. H1N1 never did appear. December 1976 was remarkable for the lack of any influenza epidemic.

Lawyers flooded the U.S. Attorney General’s office with claims on behalf of clients alleging they had suffered damages of various kinds due to the Swine Flu vaccine. 4,181 claims were filed seeking a total of $3.2 billion. After a decade and a half, the government would settle 393 claims for $37,789,000. Another 1,605 cases would end up in court, with 110 resulting in judgements against the federal government for a total of $47,693,000.

In the end, the U.S. government paid out over $100 million in taxpayer dollars to Swine Flu vaccine claimants.

The 1976 Swine Flu debacle set a precedent that would haunt all vaccine efforts in the United States for decades, and shatter the confidence of vaccine manufacturers, and their insurers, not only for their U.S. markets, but globally. Most pharmaceutical companies abandoned vaccine production entirely, leaving only four companies committed to production of vaccines.

Still, the Swine Flu affair fails to tell us whether, in the face of scientific uncertainty, it is better to err on the side of caution or aggressive intervention.

The chilling effect of that tsunami of litigation from the Swine Flu vaccination program inhibited the federal government from underwriting any mass immunizations in subsequent decades.

There was no national program in 2009 when another H1N1 Swine Influenza-A virus became a pandemic and infected an estimated 60 million Americans and killed 12,469. Instead, the Food and Drug Administration approved four vaccines that were biological cousins of existing flu inoculations. They were widely distributed to those groups most at risk, but were less effective for adults than for children.

Much of the American public’s hesitance to embrace vaccines — the flu vaccine in particular – can be attributed to the long-lasting effects of the failed 1976 campaign to mass-vaccinate the public against a strain of the Swine Flu virus. This government-led campaign was a debacle that put an irreparable dent in future public health initiatives, as well as contributing to the public’s skepticism of flu vaccination and vaccines in general.

The world is racing to develop a vaccine for Covid-19. Efficacy and safety are paramount and need to be firmly established before mass-vaccination begins.

It may not be as quick and easy as people may think.

The Public Health Legacy of the 1976 Swine Flu Outbreak …

https://www.discovermagazine.com/health/the-public-health-legacy-of-the-1976-swine-flu-outbreak

30 Sep 2013

The Long Shadow of the 1976 Swine Flu Vaccine ‘Fiasco …

https://www.smithsonianmag.com/smart-news/long-shadow-1976-swine-flu-vaccine-fiasco-180961994/

6 Feb 2017

Reflections on the 1976 Swine Flu Vaccination Program – CDC

https://wwwnc.cdc.gov/eid/article/12/1/05-1007_article

16 Feb 2012

Swine flu of 1976: lessons from the past – WHO

https://www.who.int/bulletin/volumes/87/6/09-040609/en/

 

1 COMMENT

  1. I always appreciate your articles! Well researched and informative. I don’t think lessons of the past will stop researchers from trying to produce a covid vaccine as quickly as possible. Big bucks and “we did it first” mentality…

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