Thursday, August 19, 2021

A Short History Lesson on Vaccine

 Back in the 1950s, polio spread across the U.S., and everyone was afraid that their children would be the next to get the disease.  Dr.Salk came up with a polio vaccine that would save thousands of children.  Things were on track to eliminate the deadly disease.  Cutter Laboratories was approved to start the production of the vaccine.

Cutter Laboratories was a family-owned pharmaceutical company located in Berkeley, California, founded by Edward Ahern Cutter in 1897. Cutter's early products included anthrax vaccine, hog cholera (swine fever), anti-hog cholera serum—and eventually a hog cholera vaccine. The hog cholera vaccine was the first tissue culture vaccine, human or veterinary, ever produced. The company expanded considerably during World War II due to government contracts for blood plasma and penicillin. After Edward Cutter's death, his three sons—Dr. Robert K. Cutter (president), Edward "Ted" A. Cutter Jr. (vice-president), and Frederick A. Cutter—ran the company. In the next generation, Robert's son David followed his father as president of the company. The Bayer pharmaceutical company bought Cutter Laboratories in 1974.

On April 12, 1955, following the announcement of the success of the polio vaccine trial, Cutter Laboratories became one of several companies that were recommended to be given a license by the United States government to produce Salk's polio vaccine. In anticipation of the demand for vaccines, the companies had already produced stocks of the vaccine, and these were issued once the licenses were signed.

In what became known as the Cutter incident, some lots of the Cutter vaccine—despite passing required safety tests—contained live poliovirus in what was supposed to be an inactivated-virus vaccine. Cutter withdrew its vaccine from the market fifteen days later, on April 27, after vaccine-associated cases were reported.

The mistake produced 120,000 doses of polio vaccine that contained live poliovirus. Of children who received the vaccine, 40,000 developed abortive poliomyelitis (a form of the disease that does not involve the central nervous system), 56 developed paralytic poliomyelitis—and of these, five children died from polio. The exposures led to an epidemic of polio in the families and communities of the affected children, resulting in a further 113 people being paralyzed and five deaths. The director of the microbiology institute lost his job, as did the equivalent of the assistant secretary for health. Secretary of Health, Education, and Welfare Oveta Culp Hobby stepped down. Dr. William H. Sebrell Jr, the director of the NIH, resigned.

Surgeon General Scheele sent Drs. William Tripp and Karl Habel from the NIH to inspect Cutter's Berkeley facilities, question workers, and examine records. After a thorough investigation, they found nothing wrong with Cutter's production methods. A congressional hearing in June 1955 concluded that the problem was primarily the lack of scrutiny from the NIH Laboratory of Biologics Control (and its excessive trust in the National Foundation for Infantile Paralysis reports).

Several civil lawsuits were filed against Cutter Laboratories in subsequent years, the first of which was Gottsdanker v. Cutter Laboratories. The jury found Cutter not negligent but liable for breach of an implied warranty and awarded the plaintiffs monetary damages. This set a precedent for later lawsuits. All five companies that produced the Salk vaccine in 1955—Eli Lilly, Parke-Davis, Wyeth, Pitman-Moore, and Cutter—had difficulty completely inactivating the poliovirus. Three companies other than Cutter were sued, but the cases settled out of court.

The Cutter incident was one of the worst pharmaceutical disasters in U.S. history and exposed several thousand children to live poliovirus on vaccination. The NIH Laboratory of Biologics Control, which had certified the Cutter polio vaccine, had received advanced warnings of problems: in 1954, staff member Dr. Bernice Eddy reported to her superiors that some inoculated monkeys had become paralyzed provided photographs. William Sebrell, the director of NIH, rejected the report.

For a brief period, the "Cutter Incident" shut down the ambitious vaccination program and threatened to scuttle the effort that ultimately eliminated polio from the United States. The accidental paralysis of those healthy children is now all but forgotten. Still, University of Pennsylvania pediatrician Dr. Paul Offit called it "one of the worst pharmaceutical disasters in U.S. history."

So, with this page from history, is there anything wrong with someone questioning the experimental vaccine that has killed more than ten people and thousands of people who have had adverse reactions that have changed them for life.  At least Cutter stopped what they were doing before hundreds were killed.  I find a significant contrast between what happened then and what is happening now.  The director of the microbiology institute lost his job, as did the equivalent of the assistant secretary for health. Secretary of Health, Education, and Welfare Oveta Culp Hobby stepped down. Dr. William H. Sebrell Jr, the director of the NIH, resigned.  Even after questions of safety, Johnson and Johnson's vaccine is still on the market.  The FDA announced a very slight risk that people getting the vaccine could develop Guillain-Barre syndrome. It's a neurological issue that can lead to muscle weakness, sometimes paralysis. And it's not good, but it is very rare. About 100 cases have been reported to the CDC.  Rather than taking it off the market, it was allowed to continue.  Even after all the problems in the past with vaccines, you would think the FDA would be more proactive in stopping unsafe vaccines. 

Earlier this spring, there were contamination issues for Johnson and Johnson at their Baltimore factory. In April, a rare blood clotting disorder caused the vaccine to be put on pause. This is one vaccine supplier.  There have been significant issues with all the vaccines, which I might add vaccines are in the experimental stage and not approved by the FDA as a safe vaccine.  There is not one vaccine on the market that will keep you from getting COVID.  The CDC is not tracking the "breakthrough" cases, so they have no idea how many vaccinated people have died from COVID.  Even the vaccinated people are carriers of COVID and can infect even the vaccinated.

If someone does not wish to take the vaccine, those who have taken the vaccine should respect their choice of not taking the vaccine.  I find it interesting that those who have taken the vaccine and discover the long-term dangers of the vaccine are now having "buyer's regret." I have listened to people bemoan the fact they took the vaccine.  They wish they had done more research on the long-term effects on their health.  With more than 70% of those over six-five having taken the vaccine.  In some areas, 100% of those over sixty-five are vaccinated.  What will be the adverse effects on older people in the next few years? 

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