The meeting of the U.S. Food and Drug Administration’s (FDA) vaccines advisory committee last week was perhaps the most momentous in the agency’s history. A panel of outside experts chosen by the agency was asked whether the FDA should authorize emergency use of a still-experimental vaccine to curb the pandemic that has killed hundreds of thousands of Americans and devastated the nation.

But the FDA and the acting chairman of the committee, a former consultant to one of the companies that made the vaccine, curbed and corralled the discussion — cutting off questions, limiting debate and forcing committee members to cast an up-or-down vote without giving them a chance to vote on any refinement to the authorization.

In the end, the committee voted 17 – 4 with one abstention to recommend emergency authorization of the vaccine developed by Pfizer and its partner BioNTech.

Whether that was the best decision — whether the vaccine’s benefits outweigh its risks for people 16 and older — isn’t the issue here. At issue here is part of the process by which the FDA and its advisory committee arrived at that conclusion.

As it unfolded online, the virtual meeting on Dec.10 seemed to degenerate into a race to the finish — and an outcome that seemed all but preordained.

The FDA’s handpicked acting committee chairman, University of Michigan professor of epidemiology Dr. Arnold Monto, 87, punctuated the dialogue with efforts to hurry it along.

“Okay, we have many, many questions and we’re going to have to limit them.”

“We need to keep it brief.”

“No follow up. We’re pressed for time. I got 10 people who want to ask questions.”

“I’m going to excuse Dr. Fink” — Doran Fink of the FDA — “from having to answer that part of the question.”

“Okay, we’re going to not worry about adaptive and innate immune responses right now. We’ll take that offline.”

“I think we want to stay away from more discussions about immune response and other things that could be taken offline.”

“Very quickly!”

“Let’s keep the answer relatively short. That’s a very big question.”

“One part only!”

Toward the end of the daylong meeting, a committee member from the National Institutes of Health tried to ask a two-part question.

“That would be my first question,” he said. “The other — ”

Monto cut him off.

“I said one part only.”

“Well, I’m just going to put my hand up again then, Arnold,” the committee member said.

“Then you’ll go to the bottom of the queue,” Monto said.

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Via https://childrenshealthdefense.org/defender/how-fda-approved-pfizer-covid-vaccine-warp-speed/