FDA signals vaccine could green light early

Their concern that the FDA may be moving too quickly heightened when FDA Commissioner Dr. Steven Hahn told the Financial Times that his agency could consider an emergency use authorization (EUA) for a Covid-19 vaccine before late stage clinical trials are complete if the data show strong enough evidence it would protect people.

The commissioner has the authority to allow unapproved medical products to be used in an emergency when there are no adequate or approved alternatives. An EUA is not the same as full approval and it can be withdrawn.

That’s what happened with hydroxychloroquine and chloroquine. The FDA granted an EUA to the drugs – much praised by President Donald Trump – on March 28. It subsequently revoked its EUA in June after studies showed they were not effective and could also potentially cause serious heart problems.

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Growing distrust in the US

It took several incidents for people to start distrusting vaccines. Even after thousands of kids got sick from the first polio vaccine in 1955, when the program restarted, parents made sure their children got vaccinated. They had clear memories of epidemics that paralyzed between 13,000 and 20,000 children every year. Some were so profoundly paralyzed that they could not even breathe easily on their own, and relied on machines called iron lungs to help them breathe.

“Parents were pushing their kids to get to the head of the line to get the polio vaccine, because they had seen epidemics every summer for years, and saw kids in iron lungs and they were terrified,” Markel said.

Markel said people’s attitudes started to change between 1955 and the problematic 1976 swine flu vaccination project.

“You’ve got civil rights, when people see the cops beating the hell out of people on TV. You’ve got the Vietnam War where people start to get disgusted with the killing. You’ve got Watergate when the president is literally lying through his teeth,” Markel said. “That led to a real distrust of authorities and federal government, and it extended to doctors and scientists. And, that’s only progressed as time