Long before the breakthrough of the first trials of a polio vaccine, the disease had been one of the most dreaded in the United States. Americans feared polio only “second to the atomic bomb.” The devastation that polio came with especially on children like paralysis and death, necessitated the need for a vaccine to end the scourge. The relief of a new vaccine was also mixed with a faulty manufacturing process that ultimately resulted in hundreds of children being sickened, paralyzed, and some even died.
The breakthrough of the 1955 polio vaccine has been described as one of America’s greatest medical developments and at the same time one of its worst biological disasters. The pressure and urgency to create a vaccine in the fastest time available saw Cutter Laboratories from California creating faulty vaccines, even though they had passed safety tests. The process of inactivating the live virus proved to be defective. The faulty vaccine caused 40 000 cases of polio, leaving 200 children with varying degrees of paralysis and killing 10. This is now commonly referred to as the ‘Cutter Incident.’
Almost every parent in the United States in the 20th century, before the vaccine came, was utterly terrified of polio. Although the 1950s summer outbreaks caused tens of thousands of cases, most people would recover, but hundreds were left paralyzed and some died. Perhaps the most notable victim of polio was President Franklin D Roosevelt, who experienced paralysis when polio hit him when he was 39.
Paul A. Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, gave an account of how people were gripped by fear of polio, just as people are terrified of COVID-19 now.
“People weren’t sure how you got it. Therefore, they were scared of everything. They didn’t want to buy a piece of fruit at the grocery store. It’s the same now… Everybody’s walking around with gloves on, with masks on, scared to shake anybody’s hand.”
The 1952 polio outbreak was severely devastating. This outbreak infected 57,000 people, paralyzed 21,000, and killed 3,145. The next year there were 35,000 infections, and 38,000 the year after that.
Surviving polio often meant that one was subjected to wearing painful metal braces on their paralyzed legs or had to be placed in so-called iron lungs, which helped them breathe. And this was because there was no treatment or vaccine yet.
Jonas Salk of the University of Pittsburgh received a grant from the National Foundation for Infantile Paralysis in 1951 to find a new vaccine. The onerous task of finding a new vaccine saw him taking live poliovirus, killing it with formaldehyde until it was not infectious, but the killed virus still provided virus-fighting antibodies. It was safe. Tests had proved that his method of developing the new vaccine (killing the poliovirus) was safe. Public pressure then mounted for large-scale trials of the vaccine.
Salk tested the vaccine on himself, his wife, and three children in 1953. In April 1954, a 6-year-old second-grader became the first to be vaccinated in a massive field study. Salk’s vaccine was given to 420,000 children. A placebo was given to 200,000. And 1.2 million were given nothing. The conclusion from these studies carried a concrete resolution - children who did not get the vaccine were three times more likely to be paralyzed with polio than those who received the vaccine.
Against this backdrop, there was a rush from drug manufacturing companies to acquire licenses to commence the production of the vaccine. One of the companies that were granted the license was Cutter Laboratories. In August 1954, when new batches of the vaccine were being checked for safety purposes, it was discovered that a sample from Cutter Laboratories had given polio to a test monkey. Instead of containing the killed virus, the sample from Cutter contained live, infectious virus. But the officials granting licenses were never made aware of the faulty vaccine from Cutter Laboratories.
Five drug firms issued the new vaccine. Cutter Laboratories issued 165 000 doses of the vaccine. Cases of children falling sick, being paralyzed and dying soon ensued. A faulty vaccine was being administered to children and it was a disaster. Some who got the vaccine from Cutter went on to infect family members and neighbors. On government orders, the Cutter vaccine was withdrawn from the market, but the damage had been done already.
In the context of the world today, where there is intense public pressure to develop a vaccine for COVID-19, extreme caution must be exercised. It would be a disaster to repeat the Cutter Incident by delivering faulty vaccines. Interestingly, the Cutter Incident led to increased safety of vaccines, but the trauma of those who were victims of the faulty vaccine was enormous.
Paul Offit exonerates Cutter Laboratories from liability arising out of their negligence, and concludes that “the federal government, through its vaccine regulatory agency... was in the best position to avoid the Cutter tragedy.” Other companies produced a safe vaccine. He argues that the inexperience at Cutter resulted in the faulty vaccines. The courts did not find Cutter liable, saying that it [Cutter] had done it's best making a new drug that was complicated to produce.
This history provides a sufficient lesson on why a COVID-19 vaccine must not be rushed due to global public pressure. The world needs to be patient with a vaccine – a vaccine that must pass all regulation and safety tests, a vaccine that must be safe for everyone in the world.