FDA Commissioner Drs. Steven Hahn told the Financial Times that the FDA is moving too fast, with his concern that his agency may consider an Emergency Use Authority (EUA) for the Kovid-19 vaccine, before a late clinical The test is complete. Show strong evidence it will protect people.
Otherwise, the vaccines have gone through the entire clinical trial process and the FDA approval process, which may take months or years.
When the vaccine-making process has been accelerated, poor results have been reported.
On April 12, 1955, the government announced the first vaccine to protect children from polio. Within days, laboratories had produced thousands of lots of vaccines. Batches made by one company, Cutter Labs, accidentally contained the polio virus and caused an outbreak.
More than 200,000 children received the polio vaccine, but the government had to abandon the program within a few days.
Pediatrician, Distinguished Professor, and Director of History of the History of Medicine Dr. Howard Merkel said, “Forty thousand children became polio. Some had low levels, some were left with paralysis, and about 10 died.” University of Michigan. The government suspended the vaccination program until it could determine what went wrong.
However, the increased overlight failed to detect another problem with the polio vaccine.
Medical anthropologist S. Lochan Jain said, “The way they develop the virus was on monkey tissues. These rhesus macaques were imported from India, thousands of them.” Jain, who teaches the history of the vaccine course at Stanford and is working for the publication, said, “The gang of people stopped and in the circumstances that did not die, many became ill and the virus spread quickly.” About the incident. Scientists wrongly thought that the formaldehyde they used would kill the virus. “It was being transferred to millions of Americans,” Jain said.
No current vaccine carries the SV40 virus, the CDC states, and there is no evidence that contamination has harmed anyone.
Epidemic that was never
In 1976, scientists predicted an epidemic of a new strain of influenza called swine flu. More than 40 years later, some historians call it a “flu pandemic that was never there”.
“President Ford was originally told by his advisors that, look, we have an epidemic flu called swine flu that can be as bad as the Spanish flu,” said Michael Kinch, a professor of radiation oncology at the University of Medicine School at Washington University. St. Louis. His latest book, “Between Hope and Fear”, explores the history of vaccines.
Kinch said, “Ford was being cajoled to put in a vaccine that was put in a hurry. When you have such a new stress situation, they had to do it on the fly,” Kinch he said.
Ford decided to make vaccination mandatory.
According to the CDC, the government launched the program in about seven months and 40 million people were vaccinated with the swine flu. That vaccination campaign was later linked to cases of a neurological disorder called Guillain-Barre syndrome, which may develop after an infection or, rarely, after vaccination with a live vaccine.
“It was kind of a nuisance,” Merkel said. “The good news is that there was never an epidemic of swine flu. So we were safe, but it shows what can happen.”
Increased mistrust in America
Many incidents took place to get people started to get vaccinated. Even after thousands of children fell ill with the first polio vaccine in 1955, when the program resumed, parents ensured that their children get vaccinated. He had clear memories of the epidemic that crippled between 13,000 and 20,000 children each year. Some were so paralyzed that they could not even breathe easily on their own, and relied on machines called iron lungs to help them breathe.
“Parents were insisting on getting their children to the head of the line to get the polio vaccine, as they had seen the summer epidemic every year, and saw the children in iron lungs and were terrified , “Merkel said.
Markle said that people’s attitudes began to change between 1955 and the problematic 1976 swine flu vaccination project.
“You’ve got civil rights, when people see the police beating people of hell on TV. You’ve got the Vietnam War where people hate killing. You got Watergate when the president literally lied. Is. Through his teeth, “Merkel said. “This led to a real distrust of officials and the federal government, and it spread to doctors and scientists. And, it has only progressed over time.”
A ‘callously stupid’ trick
Merkel said people’s distrust of the system creates the idea that the FDA will start the process late before clinical trials are completed. “Broadly stupid.”
“It’s one of the most ridiculous things I’ve heard this administration say,” Merkel said. “It is basically a vaccine program that we desperately need against this virus is a bad side effect for the botch. It is a prescription for disaster.”
FDA Commissioner Hahn said the vaccine’s decision would be based on politically based data, but Kinch shared Merkel’s concern.
“It can do a lot of damage,” Kinch said. Kinch, who is a patient in one of the vaccine tests, said the clinical trial process needed to be followed to the end. Too soon the EUA for vaccines may cause a “nightmare scenario” for a few reasons.
One, the vaccine may not be safe. Two, if it is not safe, people will lose faith in vaccines. Three, if a vaccine does not provide complete protection, people will have a wrong sense of security and their risk will increase. Four, if a substandard vaccine gets the EUA, a better vaccine may never be approved, as people would be reluctant to enroll in a trial and could afford to receive a placebo instead of a vaccine.
“If we pay attention to this, people are going to die unnecessarily,” said Kinch. “We have got this right.”