Their concern that the FDA might be moving too fast increased when FDA Commissioner Dr. Steven Hahn told the Financial Times that his agency could consider an Emergency Authorization (EUA) for a Covid-19 vaccine before late-stage clinical trials are completed if the data shows strong enough evidence to keep people safe.
Otherwise, vaccines have had to go through the entire clinical trial and FDA approval process, which can take months or years.
When the vaccine manufacturing process was speeded up, the results were poor.
The cutter incident
On April 12, 1955, the government announced the first vaccine to protect children from polio. In a matter of days, laboratories had produced thousands of vaccines. Batches from one company, Cutter Labs, accidentally contained live poliovirus and caused an outbreak.
More than 200,000 children received the polio vaccine, but within a few days the government had to cancel the program.
“Forty thousand children developed polio. Some had low scores, a few hundred were paralyzed, and about ten died,” said Dr. Howard Markel, pediatrician, distinguished professor and director of the Center for the History of Medicine at the University of Michigan. The government suspended the vaccination program until it could determine what had gone wrong.
However, increased supervision could not find any other problem with the polio vaccine.
“The way they would grow the virus was on monkey tissues. These rhesus monkeys were imported from India, tens of thousands of them,” said medical anthropologist S. Lochlann Jain. “They were locked up in gangs and under those conditions those who didn’t die on the trip got sick and the virus spread quickly,” added Jain, who taught a vaccination history course at Stanford and is working on a publication on the incident. Scientists mistakenly thought the formaldehyde they were using would kill the virus. “It has been broadcast to millions of Americans,” Jain said.
No vaccines currently contain the SV40 virus, according to the CDC, and there is no evidence that the contamination has harmed anyone.
The epidemic that never existed
In 1976, scientists predicted a pandemic of a new strain of influenza called swine flu. More than 40 years later, some historians call it “the flu epidemic that never existed”.
“President Ford was basically told by his advisors that we have a pandemic flu called swine flu, which can be as bad as Spanish flu,” said Michael Kinch, professor of radiation oncology at Washington University’s Medical School in Washington St. Louis. His latest book, Between Hope and Fear, examines the history of vaccines.
“Ford was persuaded to propose a vaccine, which was hastily put together. If you have a brand new exposure situation like this, you had to do it on the fly,” Kinch said.
Ford made the decision to make vaccination mandatory.
The government started the program in about seven months and 40 million people were vaccinated against swine flu, according to the CDC. This vaccination campaign was later linked to cases of a neurological disorder called Guillain-Barre syndrome, which can develop after infection or rarely after vaccination with a live vaccine.
“It was kind of a fiasco,” said Markel. “The good news is that there never was a swine flu epidemic. So we were safe, but that shows you what could happen.”
Growing distrust in the USA
It took several incidents before people began to distrust vaccines. Even after thousands of children fell ill from the first polio vaccine in 1955, when the program restarted, parents made sure their children were vaccinated. They had clear memories of epidemics that paralyzed between 13,000 and 20,000 children each year. Some were so paralyzed that they could not breathe easily on their own and relied on machines called iron lungs to help them breathe.
“Parents urged their children to get to the top of the line to get the polio vaccine because they had seen epidemics every summer for years and saw children in iron lungs and were afraid,” Markel said.
Markel said people’s attitudes changed between 1955 and the troubled 1976 swine flu vaccination project.
“You have civil rights when people see the cops on TV beating people up. You have the Vietnam War where people start getting angry about the killing. You have Watergate when the president literally lies through the teeth.” said Markel. “This has led to a real distrust of the authorities and the federal government and has spread to doctors and scientists. And that has only developed over time.”
A “colossally stupid” move
Markel said people’s distrust of the system makes the idea that the FDA would speed up this process before the late-stage clinical trials are completed “Colossally stupid.”
“This is one of the most ridiculous things I’ve heard from this government,” said Markel. “All it takes is one bad side effect to botch a vaccination program that we desperately need against this virus. It’s a recipe for disaster.”
FDA Commissioner Hahn said the vaccination decision will be based on data, not policy, but Kinch shares Markel’s concern.
“This could do significant damage,” Kinch said. Kinch, who is himself a patient in one of the vaccine studies, said the clinical trial process must be followed through to the end. An EUA too early for a vaccine could create a “nightmare scenario” for several reasons.
First, the vaccine may not be safe. Second, when it’s not safe, people lose confidence in vaccines. Third, when a vaccine does not provide full protection, people feel a false sense of security and increase their risk. Fourth, if a poor quality vaccine is given an EEA, a better vaccine may never get approved because people are reluctant to participate in trials and run the risk of being given a placebo instead of a vaccine.
“People will die needlessly if we take risks with it,” Kinch said. “We have to do this right.”