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Tags: Biden Administration | Coronavirus | Health Topics | Vaccines | Cold/Flu | scott gottlieb | vaccine approval

Public Health Using 'Peacetime Process' for Vax Approval in 'Wartime Setting'

the scales of justice in an illustration with coronavirus and vials of the covid-19 vaccine
(Dreamstime)

By    |   Sunday, 26 September 2021 03:13 PM

The nation used a "peacetime process" for vaccination approval during a "wartime setting," former Food and Drug Administration commissioner Dr. Scott Gottlieb lamented Sunday.

"There should be a different process entirely; we used a peacetime process for a wartime setting," Gottlieb told CBS News' "Face the Nation."

"The way it works right now is the FDA renders a judgment about a vaccine and then it goes to a [Centers for Disease Control and Prevention] advisory panel. And the CDC oftentimes narrows the scope of the FDA approvals in terms of defining who should be eligible for a vaccine."

The process "looked messy," but it is a built-in design, he said.

"The process was designed to create conflict," he said. "We need to recognize that we used a process for adjudicating what vaccines should go into pediatric vaccine administration schedule to define who should get an adult vaccine in the setting of a public health emergency.

"The process that we use intentionally creates conflict between FDA and CDC," he added. "Because you want that process to be highly deliberative, you want to be slow. You want it to reflect very careful analysis because decisions about what vaccines should be mandated for pediatric population across the country are very weighty decisions.

"But a slow, deliberative process that creates conflict that's visible to the public isn't optimal in the setting of a public health emergency, where you need to move quickly, and you want to show that public health officials are unified. "

According to Gottlieb, the CDC and FDA should have been brought together "from the outset."

"I think in terms of how they handled it, though, I think they handled it well within the confines of the process that they were using by announcing about a month ago that they were going to pursue boosters," he added.

Gottlieb also said the data is not yet clear that everybody needs to get a booster — especially if you are under 50.

"The data is still to be determined on that question," he said.

"They authorize it for anyone 65 and above and in a long-term care facility," he noted. "I think that you can make an argument that the data suggests that people above the age of 60 and maybe even above the age of 50 should get a booster based on just a risk-benefit analysis."

"And that's where the FDA ultimately was heading in the discussion that they had. But people below the age of 50 who are otherwise healthy, I think it's an open question right now," he said.

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The nation used a "peacetime process" for vaccination approval during a "wartime setting," former Food and Drug Administration commissioner Dr. Scott Gottlieb lamented Sunday.
scott gottlieb, vaccine approval, fda, cdc, commissioner
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2021-13-26
Sunday, 26 September 2021 03:13 PM
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