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.
Dr. Arnold Monto, the acting chairman of the vaccines advisory committee, curbed and corralled the discussion to authorize emergency use of the Pfizer vaccine — 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.
Was the FDA interested in what its advisory committee members had to say? Or was it more interested in going through the motions of consulting outside experts and projecting the appearance of a thorough and objective process?
As committee members pointed out, they had weighty issues to consider. With more people dying from COVID-19 each day than perished in the terrorist attacks of September 11, the nation has become desperate for relief. But the vaccine employs pathbreaking mRNA technology, and, in an ongoing clinical trial, test subjects had been followed for a median of only two months of safety observations after receiving the second of two doses.
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